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Sumitomo Corporation Jobs

- 63 Jobs
  • Director, Regulatory Affairs

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Richmond, VA

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring. **Job Duties and Responsibilities** + Manage and Develop Talent + May train/mentor junior staff + Phases I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT) + As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product + Competently represents GRA on project team meetings + Leads and coordinates project team members in developing strategy for applicable documents/ activities. + Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines + Leads documentation of regulatory authority interactions including decisions and outcomes + Provides updates at the Global Regulatory Team meetings and project teams as needed + Collaborates effectively with regulatory operations leader (ROL) + Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed + Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy + Leads and coordinates local project team members in developing strategy for applicable documents/activities + Ensures the quality and content of all submissions to Health Authorities + Leads the regional health authority meetings, liaison with local Health Authority, + Document owner of briefing book documentation to Health Authorities + Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required + Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide strategic review of dossier summaries, expert statements, and development management plans + Provide updates to the GRT, project teams, and governance boards as needed + Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions + May be responsible for creating and reviewing SOPs and regulatory department operating procedures. **Key Core Competencies** + Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required + Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values + Ability to work in a diverse environment + Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization + Demonstrated ability to facilitate appropriate team decisions + Sense of urgency and perseverance to achieve results + Experience contributing to electronic regulatory submissions and working with regulatory templates + Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed + Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution + Proven success/major involvement in NDA/MAA/CTD submissions and approval + Capable of effectively negotiating with others while maintaining composure + Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to learn new therapeutic areas when necessary + Prior history with post-marketing/brand optimization strategies and commercial awareness + Expertise on regulations governing promotion and advertising of assigned products + Experience interacting with the FDA and ex-US Health Authorities + Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings + Ability to make complex decisions and willingness to defend difficult positions. + Comfortable presenting to all levels of the organization including Senior Management. + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs. + Master's degree required (preferably in a scientific discipline) The base salary range for this role is $183,000 to $228,800. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $183k-228.8k yearly 60d+ ago
  • Senior Clinical Project Manager, Oncology

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** Responsible for the planning, implementation, execution and management of multiple clinical studies and/or global studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations (CRO) if applicable. **Job Duties and Responsibilities** + Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines. + Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data. + Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company. + Provides oversight and management of CROs, consultants and vendors. + Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact. + Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines. + Monitors the status of clinical data collection of assigned clinical trials. + Prepares potential investigator site lists and assists with their evaluation for inclusion in the study. + Prepares and reviews study-related documents when required. + Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies. + Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required. + Participates in meetings - i.e. Study Team Meetings, Investigator Meetings, Monitors' workshops and CRO Training. + Reviews correspondences and monitoring reports relating to the studies. + Prepare and deliver program/study updates. + Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members. + Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team. + Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable). + Provides input into contracts, work orders and/or change orders. + Manages escalation of study related issues and communicates as appropriate with management and other R&D functions. + Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight. + Ensures assigned studies adhere to all applicable regulations and requirements. + Provides input as the subject matter expert for the assigned studies during regulatory inspections. + Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates. + Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required. + Evaluate CRO and vendor performance and support the improvement initiatives. + Participate in the preparation, review, updating and training of SOPs. + Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities. + May Mentor other team members. + Perform other duties as requested by the senior management. **Key Core Competencies** + Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills. + Demonstrated skills working within a matrix environment. + Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan. + Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance. + Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders + Strong attention to detail and the ability to establish priorities, schedule and meet deadlines. + Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems. + Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas + Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards. + Strong analytical skills with a data driven approach to planning, executing, and problem solving + Working knowledge of current global regulatory requirements and guidelines for clinical trials. **Education and Experience** + Bachelor's degree in a related field required. + M.S./Ph.D. in a related life science discipline is preferred. + Thorough understanding of the oncology arena. + Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials. The base salary range for this role is $137,100 to $171,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $137.1k-171.5k yearly 11d ago
  • 2nd Shift Machine Operator

    Aphena Pharma Solutions 4.2company rating

    Easton, MD Job

    Job Details Experienced Liquid & Topicals Division - Maryland - Easton, MD N/A Full Time High School $18.00 - $20.00 Hourly None Graveyard ManufacturingDescription Aphena Pharma Solutions is looking for Experienced Machine Operators on 2nd Shift to join our team in Easton, Maryland! We are a dynamic pharma solutions provider focused on contract packaging, repackaging and manufacturing for the pharmaceutical, OTC, dietary supplement, animal health and medical device marketplaces. BENEFITS INCLUDE: Employee Medical Premiums Paid at 75% by Aphena Company Pays Portion of Medical Deductible Company Paid Short Term Disability & Life Insurance 401k Match PTO Awarded After 30 Days Paid Holidays & MORE! JOB TASKS: Change material rolls of various sizes Clean and maintain ink printers Change gears, sprockets and chains Maintain jaws and replace tape as needed Stacking of raw materials and finished goods Maintain machines on a regular basis Be able to identify and replace broken and/or damaged parts Adjust computerized attributes as necessary, identify and correct machine or raw material discrepancies to assure product control Maintain safe and clean work area Record all information as specified by documented procedures Perform and record most preventative maintenance, assistance required from mechanical staff Machine setup, partial, assistance for mechanical staff required Perform hourly inspections and document results Clean/sanitize equipment or work area and document as required Move items using material handling equipment as needed Assist with varied tasks as needed JOB SKILLS: Have the ability to analyze and solve mechanical problems with assistance from Level 2 operator or mechanic Willingness to learn Technical skill and knowledge Skilled in reading, writing and counting Willingness to be trained to work on FDA regulated product lines Ability to work with other employees Ability to be open-minded to all views and decisions Attendance must be at an acceptable level Skilled in utilizing and understanding the following: inventory counting lot control multi-meter artworks & drawings measuring equipment hand tools Ability to read, write and count Possess general working knowledge of electrical controls Skilled in using required material handling equipment Receive instructions through oral communications accurately and quickly Convey answers or instructions to other workers accurately, loudly, and quickly PHYSICAL REQUIREMENTS: Must be able to lift and move materials up to a maximum of 65 pounds and carry 8 feet frequently The machine operator will be subject to dust, noise, fumes, and odors The machine operator will be exposed to inside and outside environmental conditions The physical activity of this position includes, but is not limited to: climbing, walking, stooping, kneeling, crouching, reaching, standing, pushing, pulling, lifting, grasping, twisting, sitting, and feeling Safety equipment will be provided where needed and required to be worn PERSONAL ATTRIBUTES: Energetic Works well with others Works well under pressure Works well with minimal supervision Can manage multiple priorities Self-motivated Trustworthy Good personal hygiene Dependable EDUCATION EXPERIENCE & REQUIREMENTS: HS diploma Prefer vocational training Operator/mechanic experience is a plus and will be compensated manufacturing: 2 years (Preferred) machine operator: 1 year (Preferred) Must be willing to work Monday through Thursday, 4 x 10-hour shifts from 5:30P-7:00A with possible mandatory overtime on Friday as needed from 3:30P-12:00A The schedule for the shift and workstation maybe subject to change Normal work week is 40 hours per week Qualifications JOB SKILLS: Have the ability to analyze and solve mechanical problems with assistance from Level 2 operator or mechanic Willingness to learn Technical skill and knowledge Skilled in reading, writing and counting Willingness to be trained to work on FDA regulated product lines Ability to work with other employees Ability to be open-minded to all views and decisions Attendance must be at an acceptable level Skilled in utilizing and understanding the following: inventory counting lot control multi-meter artworks & drawings measuring equipment hand tools Ability to read, write and count Possess general working knowledge of electrical controls Skilled in using required material handling equipment Receive instructions through oral communications accurately and quickly Convey answers or instructions to other workers accurately, loudly, and quickly PHYSICAL REQUIREMENTS: Must be able to lift and move materials up to a maximum of 65 pounds and carry 8 feet frequently The machine operator will be subject to dust, noise, fumes, and odors The machine operator will be exposed to inside and outside environmental conditions The physical activity of this position includes, but is not limited to: climbing, walking, stooping, kneeling, crouching, reaching, standing, pushing, pulling, lifting, grasping, twisting, sitting, and feeling Safety equipment will be provided where needed and required to be worn PERSONAL ATTRIBUTES: Energetic Works well with others Works well under pressure Works well with minimal supervision Can manage multiple priorities Self-motivated Trustworthy Good personal hygiene Dependable EDUCATION EXPERIENCE & REQUIREMENTS: HS diploma Prefer vocational training Operator/mechanic experience is a plus and will be compensated manufacturing: 2 years (Preferred) machine operator: 1 year (Preferred) Must be willing to work Monday through Thursday, 4 x 10-hour shifts from 5:30P-7:00A with possible mandatory overtime on Friday as needed from 3:30P-12:00A The schedule for the shift and workstation maybe subject to change Normal work week is 40 hours per week
    $18-20 hourly 50d ago
  • Perrigo Aspire Commercial Internship Program - Marketing Summer 2025

    Perrigo Company Corporate 4.9company rating

    Charlottesville, VA Job

    At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care. Description Overview Aspire for Greatness at Perrigo! Perrigo started more than 130 years ago in rural Michigan, and today it is one of the largest over the counter (OTC) self-care companies selling products globally. Our team is focused on North America and we are driven by our mission to bring quality, affordable self-care products to our consumers and retail partners. We're looking for individuals who display strong teamwork, analytical skills, and a solution-oriented mindset to join our marketing teams as we expand into new and exciting categories. Join the Aspire program to elevate your journey This summer, embrace the opportunity to learn, grow, and aspire for greatness. Perrigo provides the framework; it's up to you to write your story of achievement. At Perrigo, we're more than a step in your career; we're a bridge to your future greatness. Join Our Dynamic Marketing Teams We seek individuals with strong teamwork, analytical prowess, and a solution-oriented mindset. In the 14-week Marketing Internship, you will drive initiatives that create customer value and contribute to sales goals. Work alongside a dedicated category team on challenging projects that will enhance your technical, communication, and leadership skills outside the classroom. This role will support our Infant Nutrition business unit, encompassing both branded and store-branded products. Scope of the Role * Lead one or more strategic projects and present final project(s) to our CSCA executive leadership team. * Dive into market research and industry data to validate trends, consumer preferences, and competitive advantages. * Spearhead new product innovations and category strategies rooted in consumer insights and sales data. * Support customer and consumer marketing, outreach, and planning. * Recommend pricing and promotional strategies that can supercharge sales and boost margins. * Collaborate cross-functionally, gaining insights into sales support, supply chain, innovation, manufacturing, finance, design, eCommerce, and consumer insights. * Set performance goals, define learning objectives, and meet project deadlines with the guidance of your supervisor and mentor. * Immerse yourself in company-sponsored training and intern events that hone your skills in marketing, sales, and personal development. * Absorb the Perrigo company culture, policies, and practices that shape every facet of our business. Experience Required * Undergraduate student majoring in Business, Marketing, or related field; junior or senior standing preferred. * Prior experience in Marketing is a plus. * Showcase excellent communication, teamwork, leadership, and problem-solving skills. * Demonstrate the ability to work independently and engage professionally with leadership at all levels. * Proficiency in Microsoft Office Suite is required. Additional Considerations * Opening in Charlottesville, Virginia * Full-time, 40 hours per week * 14- week internship: May-Aug 2025 Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV #weareperrigo Nearest Major Market: Charlottesville Nearest Secondary Market: Virginia
    $22k-33k yearly est. 27d ago
  • Blender Technician

    Aphena Pharma Solutions 4.2company rating

    Easton, MD Job

    Job Details Experienced Liquid & Topicals Division - Maryland - Easton, MD N/A Full Time High School $20.00 - $24.00 Hourly None Any ManufacturingDescription Aphena Pharma Solutions is looking for Blending Technicians to join our team in Easton. MD!. We are a dynamic pharma solutions provider focused on contract packaging, repackaging and manufacturing for the pharmaceutical, OTC, dietary supplement, animal health and medical device marketplaces. Position Responsibilities • Understand and follow cGMP for all activities. • Move items using a pallet jack or forklift from the production floor to the appropriate blending area. • Execute/ensure blends are accurately prepared according to MBR's and documented procedures. Document results. Consult with Lab as needed. • Provide properly labeled samples to Lab for testing as required. • Clean/sanitize tanks and/or work areas & document as required by instructions. • Record all information as specified by documented procedures. • Ability to use and understand blending software. • Knowledge on handling, pre-weighing and disposing of hazardous materials including understanding and ability to don appropriate PPE. • Update all Log Books (Blending Activity, Preventative Maintenance, and Set Up) for Blend Work Centers. • Perform daily calibration of blending equipment such as floor scales and pH meter. • Perform or assist with preventative maintenance as necessary. • Install chart recorder as needed. • Setup blending centers in preparation for upcoming blending activities. • Assist with training other employees to become blender technicians. • Ground equipment as required. • Perform pH testing for blends when required. • NOTE: Overtime may be mandatory to maintain required production schedules. Qualifications Personal Attributes • Energetic • Works well with others • Works well under pressure • Detail oriented • Self-starter • Trustworthy • Good personal hygiene • Dependable • Works well without constant supervision Education Preference will be given to high school graduates with some vocational training Actual blending experience is a plus. Physical Requirements: • Receive instructions through oral communications accurately and quickly • Convey answers or instructions to other workers accurately, loudly, and quickly • Must be able to lift and move materials up to a maximum of 65 pounds and carry 8 feet frequently • The employee will be subject to dust, noise, fumes, and odors • Ability to don full face respirator, Self-contained Breathing Apparatus (SCBA) when required • The employee will be exposed to inside and outside environmental conditions • The physical activity of this position includes, but is not limited to: • climbing, walking, stooping, kneeling, crouching, reaching, standing, pushing, pulling, lifting, grasping, twisting, sitting, and feeling • Safety equipment will be provided where needed and required to be worn
    $20-24 hourly 60d+ ago
  • Executive Director Head of Medical Strategy

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy** will be a key member of the Medical Affairs Leadership team reporting to the Vice President, Medical Affairs. The job is responsible for managing the team of Strategy Heads for each therapeutic area and playing a critical role developing the strategy with each Therapeutic Area Strategy Head and key role with internal company cross functional alignment and external facing interactions. This job will be a key role on the Leadership team and play a highly visible role internally and externally, and effectively lead and communicate with cross-functional team members to develop and execute the strategy. The role will also collaborate closely with Commercial leadership, as appropriate, and R&D team on strategic initiatives. **Job Duties and Responsibilities** + Support one team, patient first, high energy, positive dynamic culture. + Aligning with CMO, and VP of MA, to drive medical affairs strategy for Sumitomo Pharma America Inc. + Provide input to Global/Sumitomo Pharma America Inc. R&D Strategy and other corporate functions. + Provide input to VP Medical Affairs to support budget creation and manage costs to keep within budget of Medical Affairs. + Lead, develop and mentor team members . + Specify, develop and sustain optimal internal processes, capacities and capabilities. + Develops and aligns Medical Affairs strategic plans with brand strategic imperatives based on external engagement, MSL/cross functional input and impactful insights, supporting data generation, and data communication, education and awareness stakeholders. + Support alliances, ensuring coordination and alignment of all Medical Affairs activities and budget within SMPA and with alliance partners. + Oversee the strategy and development of Medical Affairs plans and scientific platforms. + Ensure cross-functional medical alignment with the US Field Medical team, Medical Communications & Operations, RWE & HEOR and ex-US colleagues. + Direct the implementation of plans that will be executed through multi-modal medical education channels, including publications, presentations, congresses, advisory boards, CME, medical symposia and other channels. + Oversee the development and implementation of detailed scientific Publication Plans. + Work with cross functional team to develop and execute Advisory Board. + External engagement and maintain a highly visible role during exchanges within the medical/scientific community to develop close relationships with a group of scientific key opinion leaders. + Work closely with the commercial organization to bring the medical perspective to commercial strategies and tactics, aligning with Marketing & Market Access to collaborate on the most efficient and effective ways to work together. + Define and attend relevant medical and scientific conferences. + Support strategy and oversight for the development of a supportive US Investigator Initiated Study and Collaborative Research program. + Ensures that all interactions and activities in the US adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information. + Ability to travel (domestic and some international) to attend scientific congresses, participate in internal meetings, and meet key stakeholders in the development of Medical Affairs activities - up to 30% travel. **Key Core Competencies** + Dynamic leadership skills. + Strategic thinking, critical analysis and reviewing primary data to develop insights. + Ability to independently engage external stakeholders. + Excellent verbal and written communication skills, as the position will interface with key opinion leaders and a wide range of internal employees. + Ability to effectively communicate, collaborate and deliver excellent work in a fast-paced, and rapidly changing dynamic company. + Must have excellent interpersonal skills, with experience in conflict management and relationship building. + Ability to analyze complex issues critically and develop realistic and accomplishable plans and solutions, familiarity with the use and measurement of Key Performance Indicators. + One-Team attitude with the capability to work cross-functionally with peer, and other colleagues, as appropriate. + Capable of translating brand goals and objectives into actionable medical and scientific strategies. + Proven track record of detailed, medically accurate, and scientifically relevant writing and review skills in line with compliance requirements. + Experience representing a broad range of stakeholders in the development and communication of medical activities and plans. **Education and Experience** + Bachelor's degree in a related field required. + Advanced degree in medical science (MD, or PhD); MD with relevant specialization preferred. + 8+ years of relevant Medical Affairs work experience in biotech or pharmaceutical industry, or equivalent professional clinical experience. + Experience leading in a matrix team environment is considered a plus. The base salary range for this role is $274,800 to $343,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $274.8k-343.5k yearly 60d+ ago
  • Associate Scientist Strain Improvement - Columbia, MD

    DSM 4.3company rating

    Columbia, MD Job

    Associate Scientist Strain Improvement Columbia, MD, US On-Site The Strain Improvement Team has an exciting opening for an Associate Scientist! Join our Columbia Science and Research Team as we develop innovative bioprocesses in a collaborative, global and fast-paced environment. Apply and grow your expertise in strain improvement, microbiology and microbial physiology to design and execute strain development and optimization experiments at our site in Columbia, MD. At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated. Your key responsibilities * Advancing our understanding of naturally sourced and engineered organisms. * Use classical strain improvement techniques including random mutagenesis and adaptive laboratory evolution to produce new, improved organisms that deliver on project targets. * Assessing the performance of new microbial strains at small scale using high throughput assays and lower throughput orthogonal assays. * Work collaboratively in cross-functional teams that include strain, fermentation, downstream processing and analytics to achieve project goals. * Contribute to the maintenance and care of our world class culture collection and the preparation of working cell banks for our production sites. * Preparing, documenting and presenting results and scientific findings to project teams, stakeholders and management. We bring * Opportunities for growth and advancement for those who embrace innovation and take initiative. * Supportive environment where your efforts and accomplishments are recognized and celebrated. * Opportunity to build a career making a significant impact on billions of lives, with the freedom to shape your own path. * Collaboration with experts in health, nutrition and beauty to drive progress. * Dedication to creating better futures for customers, communities, people and the planet. You bring * Master's degree or BS in microbiology, biology or biochemistry with equivalent experience in microbiology, genetics, microbial cell physiology, biochemistry, microbial culturing, fermentation or related field. * Minimum of 3 years' experience in industry or professional academia, in or related to Strain Improvement or Bioprocess * A desire and dedication to a sustainable future for our customers, communities, people and the planet. * Hands-on experience with culturing and analysing microbial cells in small scale cultivation systems. * Experience with classical strain improvement and adaptive laboratory evolution a plus. * Experience with high-throughput screening methods such as liquid handling robotics, microscopy, fluorescent labelling and/or flow cytometry The application process Interested in this position? Please apply on-line by uploading your resume in English via our career portal by February 20, 2025. Equal Opportunities Commitment dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there's a place for everyone at dsm-firmenich. dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law. We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know. About dsm-firmenich As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life every day, everywhere, for billions of people. ********************* Agency Note Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency's fees, percentages or similar.
    $59k-84k yearly est. 5d ago
  • Counsel, Contracts

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a qualified, highly motivated, experienced individual for the position of **Counsel** . The position reports to **Senior Counsel** . **Counsel** will be part of a team of attorneys and legal professionals, and will help support the contracting and legal functions at Sumitomo Pharma America, Inc. The position reports to the Senior Counsel and the location is remote. This individual will be instrumental in supporting the business. He or she will primarily focus on drafting, negotiating, and managing contracts related to commercial, clinical, operational, and privacy activities and will manage issues escalated by the business related to contract intake, negotiation, drafting, records or processing, risk assessments, and guidance for a variety of business groups. Moreover, the Counsel position will also have the opportunity advise and support general matters related to technology, including artificial intelligence, privacy, employment, and disputes. **Job Duties and Responsibilities** Contract Review and Management + Independently draft, review, negotiate, and finalize commercial contracts, including NDA's, MSA's, SOW's, procurement agreements, consulting agreements, HR agreements, SaaS/technology agreements, and a variety of other agreements common in the pharmaceutical industry + Independently draft, review, negotiate, and finalize a high volume of Data Protection Addenda and other privacy agreements + Ensure contract terms are consistent with company policies and best practices + Involve relevant stakeholders in evaluating legal, compliance, financial, and business risks associated with contracts to the best protect company interests, and facilitate the escalation and resolution of complex issues as needed + Serve as a liaison with outside counsel and manage vendors + Manage one's own commercial contracts and requests within a contract lifecycle management database/platform General Advice, Counseling, and Special Projects + Advising the internal business partners on various legal matters related to contracts and technology, including artificial intelligence + Generate reports, presentations, spreadsheets, memos and other documents for the Legal Department, clients and/or the senior management team + Complete special projects such as collaborating on department-wide or company-wide initiatives Partnerships, Policy, and Training + Conduct legal research + Support the company's Strategic Sourcing group in their partnership in the contracts management process + Assist in implementing new policies and procedures + Train and guide the internal business teams on the use of new policies and procedures including use of artificial intelligence and their relevant legal issues **Key Core Competencies** + Treats people with respect and inspires the trust of others + Works creatively and with a passion for the mission of the company (" _We are in the constant pursuit of self-innovation to deliver patient first, innovative products and services with speed so that people around the world can lead healthier and more fulfilling lives_ ") + Works with integrity and ethically in accordance with company's Code of Business Conduct, policies, and procedures + Able to collaborate, as well as work independently while balancing competing priorities in a fast-paced, deadline-driven environment with a high level of professionalism + Demonstrates daily customer-service orientation and a positive, 'can do' attitude + Exhibits honesty, integrity, and trust-building behaviors in all interactions + Prioritizes self-motivation, reliability, and responsibility + Demonstrates excellent verbal and written communication skills + Able to be flexible and shift priorities as needed, and is willing to accept new responsibilities and develop professionally in substantive areas + Exercises discretion and good judgment while handling confidential and sensitive information **Education and Experience** Education + Juris Doctor from an accredited U.S. law school; admitted/licensed to practice law Experience + At least 4-8 years of experience drafting and negotiating contracts in the life sciences industry + Prior experience with biotechnology or a pharmaceutical company within a firm and/or in-house setting + Experience with new product launches is strongly preferred + Working knowledge of relevant laws, regulations, guidance and industry codes related to the pharmaceutical industry including privacy laws and regulations including as they relate to technology and artificial intelligence The base salary range for this role is $174,400 to $218,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $52k-98k yearly est. 19d ago
  • Director, Medical Affairs Strategy (Hematology/Oncology)

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** The Director, Medical Affairs Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy. In this role, individuals are responsible for Medical Affairs strategic direction and management for Pipeline Hematology/Oncology asset(s), leading the Medical Affair planning for both internal company programs and external facing interactions. The job will oversee the management peri-, pre-, and post-launch activities related to Medical Affairs function. This individual will lead program coordination with Clinical Development leadership to ensure alignment between Medical Affairs, Advocacy, Translational Medicine, and Commercial launch strategy and guide the tactical implementation of Medical Affairs plans. The Director will also collaborate with company outreach and patient advocacy efforts to ensure that Medical Affairs activities align with these patient focused programs. **Job Duties and Responsibilities** + Ensure leadership and alignment of all Medical Affairs activities and budgets for Pipeline Hematology/Oncology Product(s) within SMPA. + Manage the development of Medical Affairs strategic plans and scientific platforms in support of Pipeline Hematology/Oncology Product(s). + Represent the Oncology Products Medical Strategy Team within the Medical Affairs leadership and executive leadership teams, including presentations at the Global Medical Affair Monthly and Global Product Development Monthly Meetings. + Serve as Subject Matter Expert within Medical Affairs Team provide medical training, evaluation, motivation, and control of activities in alignment with the company's corporate strategies and objectives. + Lead cross-functional medical alignment with the US Field Medical team, Medical Communications & Operations, Japan medical affairs colleagues, RWE (Real World Evidence) & HEOR (Health Economics and Outcomes Research) for SMPA and ex-US colleagues (Basel and Canada). + Develop and direct the implementation of plans that will be executed through multi-modal medical education channels, including publications, presentations, congresses, advisory boards, CME (Continuing Medical Education), medical symposia, and other channels in support of combination therapy commercialization. + Manage the development and implementation of detailed scientific Publication Plans, Medical Advisory Boards, and Patient Advisory Boards upon review and approval of Legal and Compliance process. + Represent the Medical Affairs department on the lifecycle team to provide medical affairs input to Clinical Development and Clinical Operation's needs. + Proactively seek and create relationships directly with key opinion leaders, prominent clinical investigators, and scientific advisory groups in designated therapeutic area, providing them with credible, fair, balanced, scientific information about product development, research activities, and therapy(s) + Upon submission of NDA (New Drug Application) and approval of the VP of Medical Affairs, work closely with the commercial organization to bring the medical and pharmacoeconomic perspectives to commercial strategies and tactics, aligning with Marketing & Market Access to collaborate. + Partner with the Clinical Development organization for ongoing and post-marketing clinical development activities. + Provide detailed and compliant medical review and approval of external resources, communications, and publications - ensuring medical accuracy, relevance, and fair-balance. + Define and attend relevant medical and scientific conferences to help coordinate medical affairs activities, as well as support speakers and presenters, ensure the success of publication/communication goals, and participate in the collection and reporting of competitive intelligence within company guidelines. + Provide input into budget and long-term Medical Education programming or Medical Sponsorships. + Develop Areas of Research Interest that supports a robust and active Investigator Initiated Study program. + Ensure that all interactions and activities in the US adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information. + Serves as Medical Affairs Lead on select therapeutics topics, and provides input into developing scientific messages, + Provide feedback on Medical Information response documents. + Ability to travel (domestic and some international) to attend scientific congresses, participate in internal meetings, and meet key stakeholders in the development of medical activities - up to 30% travel. **Key Core Competencies** + Excellent verbal and written communication skills, as the position will interface with key opinion leaders and a wide range of internal employees. + Ability to effectively communicate, collaborate and deliver excellent work in a fast-paced, and rapidly changing dynamic company. + Must have excellent interpersonal skills, with experience in conflict management and relationship building. + Ability to analyze complex issues critically and develop realistic and accomplishable plans and solutions. + Mentorship attitude with the capability to work cross-functionally with peers and other colleagues, as appropriate. + Capable of translating broad corporate objectives into actionable medical and scientific strategies. + Proven record of accomplishment of detailed, medically accurate, and scientifically relevant writing and review skills in line with compliance requirements. + Experience representing a broad range of stakeholders in the development and communication of medical activities and plans. **Education and Experience** + Advanced degree in medical science (MD, PharmD, PhD) or equivalent professional hematology/oncology clinical experience; with knowledge of the acute myeloid leukemia (AML) landscape is required. + 8-10+ years of relevant professional experience in biotech, pharmaceutical industry, or related healthcare experience. + Medical Affairs and strategic planning experience within a matrix team environment is considered a plus. + Strong organizational skills, and familiarity working on PCs and the Microsoft Office Suite. The base salary range for this role is $187,800 to $234,700. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $187.8k-234.7k yearly 60d+ ago
  • Senior Manager, Biostatistics

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior** **Manager, Biostatistics.** This role will support clinical development programs by providing strategic and technical leadership in the design, analysis, and reporting of clinical studies. The Senior Manager will collaborate with cross-functional teams to ensure statistical integrity, regulatory compliance, and innovative data-driven decision-making throughout the drug development lifecycle. This role will be working as a biostats liaison between Sumitomo Pharma (SMP) and Sumitomo Pharma America, Inc. (SMPA) teams for certain projects. **Job** **Duties** **and** **Responsibilities** + List specific task and duties expected of the employee. + Include any relevant projects or initiatives the employee will be involved in + Highlight any key responsibilities that differentiate this role from others. **Statistical Leadership** + Lead statistical activities for assigned clinical studies, including protocol development, statistical analysis plan (SAP) creation, and final study reporting. + Collaborate with cross-functional teams, including clinical, regulatory, and medical affairs, to ensure study designs meet scientific and regulatory standards. + Provide statistical expertise in study design, endpoint selection, sample size determination, and innovative methodologies (e.g., adaptive designs, Bayesian methods). **Analysis and Interpretation** + Oversee and validate programming and statistical analyses conducted by internal or external teams. + Interpret and communicate statistical findings to non-statistical audiences, including senior leadership, regulatory agencies, and external stakeholders. + Prepare and present study results for regulatory submissions, publications, and internal decision-making. **Global Collaboration** + Work closely with SMPA teams and collaborate with counterparts at Sumitomo Pharma (SMP) in Japan on global projects, ensuring alignment on statistical methodologies, regulatory strategies, and data analyses. + Participate in joint meetings and initiatives to harmonize processes and share best practices across regions. **Regulatory and Compliance** + Ensure statistical deliverables comply with regulatory guidelines (FDA, EMA, ICH, etc.) and company SOPs. + Contribute to the preparation of regulatory submissions, including briefing documents, responses to agency queries, and integrated summaries of safety and efficacy (ISS/ISE). **Team Collaboration and Development** + Mentor and guide junior biostatisticians and statistical programmers. + Work closely with data management, clinical operations, clinical research, and external vendors to align statistical requirements with operational deliverables. + Stay current on advancements in biostatistics, regulatory requirements, and industry trends to bring innovative solutions to SMPA. + Identify the key competencies or attributes required to excel in the role. + Examples may include problem-solving, teamwork, communication, etc. + Highlight any specific qualities or traits that are important for success in the role. + These could include attention to detail, adaptability, creativity, etc. **Key** **Core** **Competencies** **Technical Skills** + Proficiency in statistical programming languages such as SAS and R. + Strong understanding of statistical methodologies and clinical trial design. + Knowledge of CDISC standards (SDTM, ADaM) and data visualization tools. **Soft Skills** + Excellent verbal and written communication skills. + Strong problem-solving and critical-thinking abilities. + Effective leadership and collaboration skills in a cross-functional team environment. **Education and Experience** + Master's degree in Statistics, Biostatistics, or a related field (Ph.D. preferred). + 4+ years of biostatistics experience in the pharmaceutical, biotechnology, or CRO industry. + Proven track record of leading statistical activities for clinical trials in various phases (I-IV). + Experience with regulatory submissions (e.g., INDs, NDAs, BLAs) and interacting with health authorities. + Familiarity with therapeutic areas such as oncology, CNS, urology, or women's health is a plus. The base salary range for this role is $138,400 to $173,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $138.4k-173k yearly 18d ago
  • Senior Manager, Medical Affairs Technology and Digital Innovation

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job Duties and Responsibilities** + Supports the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well as serve as the subject matter expert + Serves as the Medical Information insights and reporting subject matter expert through the Medical Information call center vendor IRMS DV system + This position will focus on Medical Information Systems for both the US and Myfembree Canada. + Ensures our Medical Information platforms and content are reliable, compliant, and scalable to support current products as well as pipeline products. + Supports and understands Medical Information and Medical Affairs systems and databases: + Perform overall management and administrative responsibilities of Veeva Vault Med Comms (content management system for medical review), IRMS, Microsoft office suite, team rooms, and other content management systems on daily bases (i.e. User Access Maintenance, Report generation, overall auditing) through technical expertise, managing new users, upgrading workflows for all review committees, identifying enhancements that can improve process efficiencies, and maintaining compliant solutions. + Manages the MIRF process + Create, implement and execute a newly enhanced SMPA Medical Affairs website after which manage and maintain (current) the SMPA website (*************************** for content, access, and upgrades/ enhancements to ensure updates and all technical maintenance updates are managed. + Continuously seek improvements within systems to ease end user experience and make sure content is updated + Manage Medical Review Committee MRC) + Make sure it adequately complies with the FDA requirements and SMPA policies regarding the dissemination of medical, scientific, and health economics and outcomes research (HEOR) information to healthcare professionals, both proactively and reactively. + Identify if the material is appropriate for MRC review and upload material to Veeva Vault MedComms for review. + Upload any offline discussions into Veeva Vault as a reference supporting material to ensure proper documentation of verdicts rendered by reviewers. + Communicate monthly MSRC/MedComms updates and metrics to Medical Affairs team. + Schedule and facilitate MRC face-to-face meetings when requested by reviewer or sponsors. + Continuously seek MRC process/workflow improvement + Manage the process and SOP + Develops and execute project plans that ensure pre- and post-product launch preparedness for medical affairs content + Implements innovations with respect to quality control mechanisms, supportive systems/databases, efficient inquiry handling workstreams, and overall dissemination of scientific information. + Assists with the execution of publication plans and supports publication team needs including but not limited to publication workflows, reports and tracking of key congress dates and milestones (where applicable and needed) + Executes ad-hoc projects that require additional technical support **Key Core Competencies** + Excellent oral and written communication skills. + Customer service skills. + Organizational, time management, and planning skills. + Highly self-motivated and able to handle multiple tasks in a timely fashion. + Critical to this individual's success will be his/her ability to interact with a wide range of functional areas within the organization, maintain a solution-oriented mentality, develop partnership and alignment among multiple internal stakeholders. + Will be bold and innovative in thinking and yet pragmatic and efficient in approach. **Education and Experience** + Bachelor's degree in a related field required. + 2-3+ years Medical Information or Medical Affairs or equivalent pharmaceutical industry experience is preferred. + Familiarity with PC based applications, including Microsoft Word, Excel and PowerPoint. + Technical expertise with content management systems (Veeva Vault) and customer relationship management systems (IRMS, Salesforce) + The role requires experience with commercial organizations, legal, medical and regulatory needs as well as internal pharmaceutical and biotechnology business processes and program/project management familiarity. + The individual will also be responsible for project coordination to improve processes and should be versed on operational efficiencies. + This candidate will have knowledge regarding AI technologies in a patient centric environment. + The role requires experience working independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive solutions forward. The ideal candidate can lead a project effectively. The base salary range for this role is $142,800 to $178,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $142.8k-178.5k yearly 60d ago
  • Associate Director Global Innovation HNC Ingredient Platforms - Flexible Location North America

    DSM 4.3company rating

    Columbia, MD Job

    Associate Director Global Innovation HNC Ingredient Platforms Location: Flexible Company within North America (Dartmouth, Canada, Columbia, MD, Arcadia, WI) Place of Work: Hybrid We know the importance of good nutrition and ways to stay healthy and so do you. We have a vacancy in our HNC Ingredient Platforms innovation team for Associate Director Global Innovation HNC. We need a dynamic and visionary candidate who will shape and develop the nutritional lipids innovation portfolio, in close alignment with the Marketing Segment Leads, Product Management team and customers. Join our team and bring progress to life with our customers. At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated. Your key responsibilities * You will have end-to-end leadership & accountability for the lipid Innovation pipeline for the HNC business group and be accountable for the delivery of the lipids ingredient platform launch pipeline from ideation to customer engagement & market launch * Scope clearly defined innovation projects within the ingredient platform and bring them to the Innovation Team for review and provide project updates * Collaborate with R&D centers to establish a strong scientific foundation for assigned projects, translating existing science on our products and ingredients into appealing and attractive claims that can be used towards customers and consumers * Drive and manage cross-functional teams including Marketing, Regulatory, Product Management and Operations to deliver projects until launch * Inspire internal & external stakeholders by bringing new ideas, staying up to date with latest scientific and technological trends, and communicating about projects and science in an accessible way * Manage external engagement with partners and customers to understand their strategic pipeline needs and to make sure the lipids ingredient platform pipeline is aligned to our customer's needs. Frequently work with external partners (academic or private companies) to deliver on pipeline deliverables. This position is eligible for the dsm-firmenich Hybrid Working model, spending 2-3 days per week in the company office and the balance of the week in a home office. We bring * A rich history and a promising future of bold scientific innovation and passionate creation with our customers, in a category of one * A space to grow by encouraging and supporting curiosity and an open mindset * The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose * A flexible work environment that empowers people to take accountability for their work and own the outcome * Barrier-free communities within our organization where every employee is equally valued and respected - regardless of their background, beliefs, or identity * A firm belief that working together with our customers is the key to achieving great things * An eagerness to be one team and learn from each other to bring progress to life and create a better future You bring * Minimum 7 years of experience in the Nutrition & Life Sciences industry, with at least years of experience in Innovation Management and/or R&D required * Minimum 5 years of experience in the lipids industry required * Proven capability to work transversally and independently and deliver product launches and exercise business impact with a strong network in the lipids space * Proven people management skills along with excellent communication & problem-solving skills * Strong project management skills and good understanding of project management processes * Master's degree in a technical discipline required Our recruitment process Interested in this position? Please apply online by uploading your resume in English via our career portal by February 24, 2025. About dsm-firmenich As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life every day, everywhere, for billions of people. ********************* dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there's a place for everyone at dsm-firmenich. dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law. We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable sharing this, please let us know. Agency Note Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency's fees, percentages or similar.
    $116k-155k yearly est. 1d ago
  • Executive Director Head of Medical Strategy

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Annapolis, MD

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy** will be a key member of the Medical Affairs Leadership team reporting to the Vice President, Medical Affairs. The job is responsible for managing the team of Strategy Heads for each therapeutic area and playing a critical role developing the strategy with each Therapeutic Area Strategy Head and key role with internal company cross functional alignment and external facing interactions. This job will be a key role on the Leadership team and play a highly visible role internally and externally, and effectively lead and communicate with cross-functional team members to develop and execute the strategy. The role will also collaborate closely with Commercial leadership, as appropriate, and R&D team on strategic initiatives. **Job Duties and Responsibilities** + Support one team, patient first, high energy, positive dynamic culture. + Aligning with CMO, and VP of MA, to drive medical affairs strategy for Sumitomo Pharma America Inc. + Provide input to Global/Sumitomo Pharma America Inc. R&D Strategy and other corporate functions. + Provide input to VP Medical Affairs to support budget creation and manage costs to keep within budget of Medical Affairs. + Lead, develop and mentor team members . + Specify, develop and sustain optimal internal processes, capacities and capabilities. + Develops and aligns Medical Affairs strategic plans with brand strategic imperatives based on external engagement, MSL/cross functional input and impactful insights, supporting data generation, and data communication, education and awareness stakeholders. + Support alliances, ensuring coordination and alignment of all Medical Affairs activities and budget within SMPA and with alliance partners. + Oversee the strategy and development of Medical Affairs plans and scientific platforms. + Ensure cross-functional medical alignment with the US Field Medical team, Medical Communications & Operations, RWE & HEOR and ex-US colleagues. + Direct the implementation of plans that will be executed through multi-modal medical education channels, including publications, presentations, congresses, advisory boards, CME, medical symposia and other channels. + Oversee the development and implementation of detailed scientific Publication Plans. + Work with cross functional team to develop and execute Advisory Board. + External engagement and maintain a highly visible role during exchanges within the medical/scientific community to develop close relationships with a group of scientific key opinion leaders. + Work closely with the commercial organization to bring the medical perspective to commercial strategies and tactics, aligning with Marketing & Market Access to collaborate on the most efficient and effective ways to work together. + Define and attend relevant medical and scientific conferences. + Support strategy and oversight for the development of a supportive US Investigator Initiated Study and Collaborative Research program. + Ensures that all interactions and activities in the US adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information. + Ability to travel (domestic and some international) to attend scientific congresses, participate in internal meetings, and meet key stakeholders in the development of Medical Affairs activities - up to 30% travel. **Key Core Competencies** + Dynamic leadership skills. + Strategic thinking, critical analysis and reviewing primary data to develop insights. + Ability to independently engage external stakeholders. + Excellent verbal and written communication skills, as the position will interface with key opinion leaders and a wide range of internal employees. + Ability to effectively communicate, collaborate and deliver excellent work in a fast-paced, and rapidly changing dynamic company. + Must have excellent interpersonal skills, with experience in conflict management and relationship building. + Ability to analyze complex issues critically and develop realistic and accomplishable plans and solutions, familiarity with the use and measurement of Key Performance Indicators. + One-Team attitude with the capability to work cross-functionally with peer, and other colleagues, as appropriate. + Capable of translating brand goals and objectives into actionable medical and scientific strategies. + Proven track record of detailed, medically accurate, and scientifically relevant writing and review skills in line with compliance requirements. + Experience representing a broad range of stakeholders in the development and communication of medical activities and plans. **Education and Experience** + Bachelor's degree in a related field required. + Advanced degree in medical science (MD, or PhD); MD with relevant specialization preferred. + 8+ years of relevant Medical Affairs work experience in biotech or pharmaceutical industry, or equivalent professional clinical experience. + Experience leading in a matrix team environment is considered a plus. The base salary range for this role is $274,800 to $343,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $274.8k-343.5k yearly 60d+ ago
  • Counsel, Contracts

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Richmond, VA

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a qualified, highly motivated, experienced individual for the position of **Counsel** . The position reports to **Senior Counsel** . **Counsel** will be part of a team of attorneys and legal professionals, and will help support the contracting and legal functions at Sumitomo Pharma America, Inc. The position reports to the Senior Counsel and the location is remote. This individual will be instrumental in supporting the business. He or she will primarily focus on drafting, negotiating, and managing contracts related to commercial, clinical, operational, and privacy activities and will manage issues escalated by the business related to contract intake, negotiation, drafting, records or processing, risk assessments, and guidance for a variety of business groups. Moreover, the Counsel position will also have the opportunity advise and support general matters related to technology, including artificial intelligence, privacy, employment, and disputes. **Job Duties and Responsibilities** Contract Review and Management + Independently draft, review, negotiate, and finalize commercial contracts, including NDA's, MSA's, SOW's, procurement agreements, consulting agreements, HR agreements, SaaS/technology agreements, and a variety of other agreements common in the pharmaceutical industry + Independently draft, review, negotiate, and finalize a high volume of Data Protection Addenda and other privacy agreements + Ensure contract terms are consistent with company policies and best practices + Involve relevant stakeholders in evaluating legal, compliance, financial, and business risks associated with contracts to the best protect company interests, and facilitate the escalation and resolution of complex issues as needed + Serve as a liaison with outside counsel and manage vendors + Manage one's own commercial contracts and requests within a contract lifecycle management database/platform General Advice, Counseling, and Special Projects + Advising the internal business partners on various legal matters related to contracts and technology, including artificial intelligence + Generate reports, presentations, spreadsheets, memos and other documents for the Legal Department, clients and/or the senior management team + Complete special projects such as collaborating on department-wide or company-wide initiatives Partnerships, Policy, and Training + Conduct legal research + Support the company's Strategic Sourcing group in their partnership in the contracts management process + Assist in implementing new policies and procedures + Train and guide the internal business teams on the use of new policies and procedures including use of artificial intelligence and their relevant legal issues **Key Core Competencies** + Treats people with respect and inspires the trust of others + Works creatively and with a passion for the mission of the company (" _We are in the constant pursuit of self-innovation to deliver patient first, innovative products and services with speed so that people around the world can lead healthier and more fulfilling lives_ ") + Works with integrity and ethically in accordance with company's Code of Business Conduct, policies, and procedures + Able to collaborate, as well as work independently while balancing competing priorities in a fast-paced, deadline-driven environment with a high level of professionalism + Demonstrates daily customer-service orientation and a positive, 'can do' attitude + Exhibits honesty, integrity, and trust-building behaviors in all interactions + Prioritizes self-motivation, reliability, and responsibility + Demonstrates excellent verbal and written communication skills + Able to be flexible and shift priorities as needed, and is willing to accept new responsibilities and develop professionally in substantive areas + Exercises discretion and good judgment while handling confidential and sensitive information **Education and Experience** Education + Juris Doctor from an accredited U.S. law school; admitted/licensed to practice law Experience + At least 4-8 years of experience drafting and negotiating contracts in the life sciences industry + Prior experience with biotechnology or a pharmaceutical company within a firm and/or in-house setting + Experience with new product launches is strongly preferred + Working knowledge of relevant laws, regulations, guidance and industry codes related to the pharmaceutical industry including privacy laws and regulations including as they relate to technology and artificial intelligence The base salary range for this role is $174,400 to $218,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $42k-79k yearly est. 19d ago
  • Director, Pricing and Contracting - Market Access

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Pricing and Contracting.** This position reports to the **Executive Director, Pricing, Contracting & Policy** . The **Director, Pricing and Contracting** will have primary responsibility for conducting business analysis to inform the payer and provider pricing and contracting strategy as well as inform overall commercial strategy and forecasting. The role coordinates with the Market Access, Finance and brand teams to support development of pricing & contracting strategy and execution for Sumitomo Pharma America's product portfolio. This position can be based remotely out of any US-based remote/home office. **Job Duties and Responsibilities** + Support development of communications with Senior Executives and strategic partners to report analytical findings and key performance metrics + Develop models to set pricing strategy with the goal of supporting attainment of coverage goals and maximizing net revenue + Develop payer & provider deal models to assess the implications of deal scenarios on gross-to-net revenue and support development of business cases for review & approval by the Pricing Committee + Develop & refine gross-to-net models to support reporting and forecasting of short and long-range discount rates for Finance and the brand teams + Collaborate with the Market Access team on contract changes and amendments + Support roll-out of contracts to field staff + Review internal data/reports to ensure compliance with government pricing programs + Provide issue resolution and presentation of solutions from contract disputes + Support government price reporting and state price transparency reporting requirements **Key Core Competencies** + Experience in pharmaceutical secondary analytics and financial modeling + Understanding of Commercial and Medicare Part D pharmacy benefit designs + Understanding of gross-to-net and ROI calculations + Ability to prioritize and manage multiple tasks/assignments and meeting short deadlines + Interest in exploring and developing new approaches, processes and methodologies + Experience evaluating PBM/payer contracts to ensure they support Market Access objectives + Highly-skilled in influencing and effectively partnering with cross-functional teams + Excellent interpersonal, oral and written communication skills, project management, and confident executive presence + High level of proficiency with Microsoft Excel and PowerPoint + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Bachelor of Arts or Science in Health Sciences or related discipline; MBA preferred + Minimum 15 - 20 years (without Master's) or 10 - 15 (with Master's) of relevant experience in biotech or pharmaceutical industry + 5-7 years' experience in data analysis, financial modeling, and decision support + Preference towards previous experience with product level forecasting The base salary range for this role is $165,800 to $207,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $165.8k-207.3k yearly 18d ago
  • Senior Manager, Clinical Trial Management

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Clinical Trials.** The Senior Manager, Clinical Trials works in Clinical Operations, managing and executing the operational aspects for clinical studies across Phase 1-4. The Senior Manager, Clinical Trials will work under the leadership of a Clinical Operations Program lead, providing leadership and driving all aspects of study execution in collaboration with cross-functional study teams and vendors for one or more clinical studies. Advance skills in clinical trial management and advance knowledge of Good Clinical Practice (GCP) and regulatory guidelines are essential in ensuring quality and compliance. **Job Duties and Responsibilities** + Manages and executes all aspects of study execution, including vendor selection and management, study start-up, enrollment management, and study close-out and reporting on assigned clinical trial(s). + Provides operational leadership within the Operational Study Team and with cross-functional team members, study sites, and vendors. + Develops and oversees the proliferation of study documents and plans to ensure adequate controls, aligning with GCP and regulatory requirements for study conduct. They will provide strong input into study protocols, informed consents, clinical study reports, and other clinical documents as appropriate for assigned studies. + Oversees the set-up, maintenance, and completeness of the Trial Master File (TMF) for inspection readiness. They will review trial data to ensure completeness and accuracy of data and reporting in collaboration with other relevant functions. + Collaborates with cross-functional teams and vendors on quality and compliance activities, ensuring continuous improvement in study conduct, proactively identifying and mitigating risks/issues to the study to ensure successful study conduct and reporting of study data. + Management of the clinical study budgets and timelines of the study in collaboration with relevant functions. + Responsible for selection, onboarding, training, and set-up of study personnel, CROs and other vendors, while regularly reviewing their performance to ensure compliance with contracts and expectations. + Provides strong leadership to clinical operation team members on assigned studies, ensuring clear roles and responsibilities, and fostering a culture of collaboration and excellence. They may have direct line manager responsibilities. + Contributes to department initiatives, workstreams and processes, including inspection readiness, as necessary. + Contributes to the development and enhancement of organizational policies and procedures. **Key Core Competencies** + Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English. + Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English. Ability to write reports, business correspondence and procedure manuals in English. + Ability to effectively present information to and respond to questions from groups of managers, sites, etc. + Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists. + Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams. + Must have demonstrated ability to work independently and in a team, and provide leadership in a management role. + Must have experience interfacing and managing multiple vendors/ contractors. + Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule. + Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel. **Education and Experience** + Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field. + Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's) years of relevant experience in biotech or pharmaceutical industry or CRO setting, with specific expertise in Phases 1-4. The base salary range for this role is $136,500 to $170,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $136.5k-170.6k yearly 15d ago
  • Executive Director Head of Medical Strategy

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Richmond, VA

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy** will be a key member of the Medical Affairs Leadership team reporting to the Vice President, Medical Affairs. The job is responsible for managing the team of Strategy Heads for each therapeutic area and playing a critical role developing the strategy with each Therapeutic Area Strategy Head and key role with internal company cross functional alignment and external facing interactions. This job will be a key role on the Leadership team and play a highly visible role internally and externally, and effectively lead and communicate with cross-functional team members to develop and execute the strategy. The role will also collaborate closely with Commercial leadership, as appropriate, and R&D team on strategic initiatives. **Job Duties and Responsibilities** + Support one team, patient first, high energy, positive dynamic culture. + Aligning with CMO, and VP of MA, to drive medical affairs strategy for Sumitomo Pharma America Inc. + Provide input to Global/Sumitomo Pharma America Inc. R&D Strategy and other corporate functions. + Provide input to VP Medical Affairs to support budget creation and manage costs to keep within budget of Medical Affairs. + Lead, develop and mentor team members . + Specify, develop and sustain optimal internal processes, capacities and capabilities. + Develops and aligns Medical Affairs strategic plans with brand strategic imperatives based on external engagement, MSL/cross functional input and impactful insights, supporting data generation, and data communication, education and awareness stakeholders. + Support alliances, ensuring coordination and alignment of all Medical Affairs activities and budget within SMPA and with alliance partners. + Oversee the strategy and development of Medical Affairs plans and scientific platforms. + Ensure cross-functional medical alignment with the US Field Medical team, Medical Communications & Operations, RWE & HEOR and ex-US colleagues. + Direct the implementation of plans that will be executed through multi-modal medical education channels, including publications, presentations, congresses, advisory boards, CME, medical symposia and other channels. + Oversee the development and implementation of detailed scientific Publication Plans. + Work with cross functional team to develop and execute Advisory Board. + External engagement and maintain a highly visible role during exchanges within the medical/scientific community to develop close relationships with a group of scientific key opinion leaders. + Work closely with the commercial organization to bring the medical perspective to commercial strategies and tactics, aligning with Marketing & Market Access to collaborate on the most efficient and effective ways to work together. + Define and attend relevant medical and scientific conferences. + Support strategy and oversight for the development of a supportive US Investigator Initiated Study and Collaborative Research program. + Ensures that all interactions and activities in the US adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information. + Ability to travel (domestic and some international) to attend scientific congresses, participate in internal meetings, and meet key stakeholders in the development of Medical Affairs activities - up to 30% travel. **Key Core Competencies** + Dynamic leadership skills. + Strategic thinking, critical analysis and reviewing primary data to develop insights. + Ability to independently engage external stakeholders. + Excellent verbal and written communication skills, as the position will interface with key opinion leaders and a wide range of internal employees. + Ability to effectively communicate, collaborate and deliver excellent work in a fast-paced, and rapidly changing dynamic company. + Must have excellent interpersonal skills, with experience in conflict management and relationship building. + Ability to analyze complex issues critically and develop realistic and accomplishable plans and solutions, familiarity with the use and measurement of Key Performance Indicators. + One-Team attitude with the capability to work cross-functionally with peer, and other colleagues, as appropriate. + Capable of translating brand goals and objectives into actionable medical and scientific strategies. + Proven track record of detailed, medically accurate, and scientifically relevant writing and review skills in line with compliance requirements. + Experience representing a broad range of stakeholders in the development and communication of medical activities and plans. **Education and Experience** + Bachelor's degree in a related field required. + Advanced degree in medical science (MD, or PhD); MD with relevant specialization preferred. + 8+ years of relevant Medical Affairs work experience in biotech or pharmaceutical industry, or equivalent professional clinical experience. + Experience leading in a matrix team environment is considered a plus. The base salary range for this role is $274,800 to $343,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $98k-165k yearly est. 60d+ ago
  • Counsel, Contracts

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Annapolis, MD

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a qualified, highly motivated, experienced individual for the position of **Counsel** . The position reports to **Senior Counsel** . **Counsel** will be part of a team of attorneys and legal professionals, and will help support the contracting and legal functions at Sumitomo Pharma America, Inc. The position reports to the Senior Counsel and the location is remote. This individual will be instrumental in supporting the business. He or she will primarily focus on drafting, negotiating, and managing contracts related to commercial, clinical, operational, and privacy activities and will manage issues escalated by the business related to contract intake, negotiation, drafting, records or processing, risk assessments, and guidance for a variety of business groups. Moreover, the Counsel position will also have the opportunity advise and support general matters related to technology, including artificial intelligence, privacy, employment, and disputes. **Job Duties and Responsibilities** Contract Review and Management + Independently draft, review, negotiate, and finalize commercial contracts, including NDA's, MSA's, SOW's, procurement agreements, consulting agreements, HR agreements, SaaS/technology agreements, and a variety of other agreements common in the pharmaceutical industry + Independently draft, review, negotiate, and finalize a high volume of Data Protection Addenda and other privacy agreements + Ensure contract terms are consistent with company policies and best practices + Involve relevant stakeholders in evaluating legal, compliance, financial, and business risks associated with contracts to the best protect company interests, and facilitate the escalation and resolution of complex issues as needed + Serve as a liaison with outside counsel and manage vendors + Manage one's own commercial contracts and requests within a contract lifecycle management database/platform General Advice, Counseling, and Special Projects + Advising the internal business partners on various legal matters related to contracts and technology, including artificial intelligence + Generate reports, presentations, spreadsheets, memos and other documents for the Legal Department, clients and/or the senior management team + Complete special projects such as collaborating on department-wide or company-wide initiatives Partnerships, Policy, and Training + Conduct legal research + Support the company's Strategic Sourcing group in their partnership in the contracts management process + Assist in implementing new policies and procedures + Train and guide the internal business teams on the use of new policies and procedures including use of artificial intelligence and their relevant legal issues **Key Core Competencies** + Treats people with respect and inspires the trust of others + Works creatively and with a passion for the mission of the company (" _We are in the constant pursuit of self-innovation to deliver patient first, innovative products and services with speed so that people around the world can lead healthier and more fulfilling lives_ ") + Works with integrity and ethically in accordance with company's Code of Business Conduct, policies, and procedures + Able to collaborate, as well as work independently while balancing competing priorities in a fast-paced, deadline-driven environment with a high level of professionalism + Demonstrates daily customer-service orientation and a positive, 'can do' attitude + Exhibits honesty, integrity, and trust-building behaviors in all interactions + Prioritizes self-motivation, reliability, and responsibility + Demonstrates excellent verbal and written communication skills + Able to be flexible and shift priorities as needed, and is willing to accept new responsibilities and develop professionally in substantive areas + Exercises discretion and good judgment while handling confidential and sensitive information **Education and Experience** Education + Juris Doctor from an accredited U.S. law school; admitted/licensed to practice law Experience + At least 4-8 years of experience drafting and negotiating contracts in the life sciences industry + Prior experience with biotechnology or a pharmaceutical company within a firm and/or in-house setting + Experience with new product launches is strongly preferred + Working knowledge of relevant laws, regulations, guidance and industry codes related to the pharmaceutical industry including privacy laws and regulations including as they relate to technology and artificial intelligence The base salary range for this role is $174,400 to $218,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $44k-85k yearly est. 19d ago
  • Senior Manager, Medical Affairs Technology and Digital Innovation

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Annapolis, MD

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job Duties and Responsibilities** + Supports the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well as serve as the subject matter expert + Serves as the Medical Information insights and reporting subject matter expert through the Medical Information call center vendor IRMS DV system + This position will focus on Medical Information Systems for both the US and Myfembree Canada. + Ensures our Medical Information platforms and content are reliable, compliant, and scalable to support current products as well as pipeline products. + Supports and understands Medical Information and Medical Affairs systems and databases: + Perform overall management and administrative responsibilities of Veeva Vault Med Comms (content management system for medical review), IRMS, Microsoft office suite, team rooms, and other content management systems on daily bases (i.e. User Access Maintenance, Report generation, overall auditing) through technical expertise, managing new users, upgrading workflows for all review committees, identifying enhancements that can improve process efficiencies, and maintaining compliant solutions. + Manages the MIRF process + Create, implement and execute a newly enhanced SMPA Medical Affairs website after which manage and maintain (current) the SMPA website (*************************** for content, access, and upgrades/ enhancements to ensure updates and all technical maintenance updates are managed. + Continuously seek improvements within systems to ease end user experience and make sure content is updated + Manage Medical Review Committee MRC) + Make sure it adequately complies with the FDA requirements and SMPA policies regarding the dissemination of medical, scientific, and health economics and outcomes research (HEOR) information to healthcare professionals, both proactively and reactively. + Identify if the material is appropriate for MRC review and upload material to Veeva Vault MedComms for review. + Upload any offline discussions into Veeva Vault as a reference supporting material to ensure proper documentation of verdicts rendered by reviewers. + Communicate monthly MSRC/MedComms updates and metrics to Medical Affairs team. + Schedule and facilitate MRC face-to-face meetings when requested by reviewer or sponsors. + Continuously seek MRC process/workflow improvement + Manage the process and SOP + Develops and execute project plans that ensure pre- and post-product launch preparedness for medical affairs content + Implements innovations with respect to quality control mechanisms, supportive systems/databases, efficient inquiry handling workstreams, and overall dissemination of scientific information. + Assists with the execution of publication plans and supports publication team needs including but not limited to publication workflows, reports and tracking of key congress dates and milestones (where applicable and needed) + Executes ad-hoc projects that require additional technical support **Key Core Competencies** + Excellent oral and written communication skills. + Customer service skills. + Organizational, time management, and planning skills. + Highly self-motivated and able to handle multiple tasks in a timely fashion. + Critical to this individual's success will be his/her ability to interact with a wide range of functional areas within the organization, maintain a solution-oriented mentality, develop partnership and alignment among multiple internal stakeholders. + Will be bold and innovative in thinking and yet pragmatic and efficient in approach. **Education and Experience** + Bachelor's degree in a related field required. + 2-3+ years Medical Information or Medical Affairs or equivalent pharmaceutical industry experience is preferred. + Familiarity with PC based applications, including Microsoft Word, Excel and PowerPoint. + Technical expertise with content management systems (Veeva Vault) and customer relationship management systems (IRMS, Salesforce) + The role requires experience with commercial organizations, legal, medical and regulatory needs as well as internal pharmaceutical and biotechnology business processes and program/project management familiarity. + The individual will also be responsible for project coordination to improve processes and should be versed on operational efficiencies. + This candidate will have knowledge regarding AI technologies in a patient centric environment. + The role requires experience working independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive solutions forward. The ideal candidate can lead a project effectively. The base salary range for this role is $142,800 to $178,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $142.8k-178.5k yearly 60d ago
  • Director, Regulatory Affairs

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma Job In Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring. **Job Duties and Responsibilities** + Manage and Develop Talent + May train/mentor junior staff + Phases I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT) + As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product + Competently represents GRA on project team meetings + Leads and coordinates project team members in developing strategy for applicable documents/ activities. + Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines + Leads documentation of regulatory authority interactions including decisions and outcomes + Provides updates at the Global Regulatory Team meetings and project teams as needed + Collaborates effectively with regulatory operations leader (ROL) + Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed + Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy + Leads and coordinates local project team members in developing strategy for applicable documents/activities + Ensures the quality and content of all submissions to Health Authorities + Leads the regional health authority meetings, liaison with local Health Authority, + Document owner of briefing book documentation to Health Authorities + Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required + Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide strategic review of dossier summaries, expert statements, and development management plans + Provide updates to the GRT, project teams, and governance boards as needed + Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions + May be responsible for creating and reviewing SOPs and regulatory department operating procedures. **Key Core Competencies** + Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required + Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values + Ability to work in a diverse environment + Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization + Demonstrated ability to facilitate appropriate team decisions + Sense of urgency and perseverance to achieve results + Experience contributing to electronic regulatory submissions and working with regulatory templates + Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed + Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution + Proven success/major involvement in NDA/MAA/CTD submissions and approval + Capable of effectively negotiating with others while maintaining composure + Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to learn new therapeutic areas when necessary + Prior history with post-marketing/brand optimization strategies and commercial awareness + Expertise on regulations governing promotion and advertising of assigned products + Experience interacting with the FDA and ex-US Health Authorities + Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings + Ability to make complex decisions and willingness to defend difficult positions. + Comfortable presenting to all levels of the organization including Senior Management. + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs. + Master's degree required (preferably in a scientific discipline) The base salary range for this role is $183,000 to $228,800. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) and Affirmative Action employer** Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. For more information about EEO and the Law, please visit the following pages: Equal Employment Opportunity is THE LAW (****************************************************************** EEO is the Law Poster Supplement Pay Transparency (*********************************************************************************************** Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $75k-111k yearly est. 60d+ ago

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Sumitomo Corporation may also be known as or be related to SUMITOMO CORP, Sumitomo and Sumitomo Corporation.