Medical director jobs in Perth Amboy, NJ - 914 jobs

A global law firm is seeking a Senior Manager, Practice Information & Communication, based in New York or San Francisco. The role involves improving business development strategies and communication efforts within the Financial Services Litigation team. Candidates should have 8+ years of relevant experience, strong project management skills, and a proficiency in communication strategies. The position offers a competitive salary range of $200,000 - $250,000 and a comprehensive benefits package including health and wellness programs. #J-18808-Ljbffr

iHope Mission Statement: The iHOPE school community strives to provide comprehensive services for our students, who present with a variety of diagnoses including Traumatic Brain Injury, Acquired Brain Injury, and other brain-based disorders. Our students participate in academic instruction with appropriate modification and adaptation, as well as therapeutic services, based upon a collaborative, researched-based model that integrates current technology. iHOPE is committed to learners with complex needs and to their social, emotional, adaptive and educational advancement. Accessibility and integration into the larger community are at the core of our belief system. Key/Essential Functions & Responsibilities Directs all administrative work in the nursing department, including assisting with the formulation and implementation of new policies and procedures, in coordination with Director of Admissions and Family Engagement. Ensures compliance of the school health program with all local, state, and federal regulations; stays abreast of new and changing regulations. Establishes protocols for managing communicable diseases, assessing the school environment for safety and health risks and employing infection control measures; ensures appropriate notifications and coordinates with regulatory agencies as needed. Assists with the development, implementation, review, and/or modification of Health and Safety-related Standard Operating Procedures to support consistent and safe management of students' health needs while in the school's care and to address new and changing regulations. Makes recommendations for improvements or changes and leads implementation and communication of school health program initiatives, informing long-term goals for the department. Ensures adequate nursing staff at all times by participating in recruitment and selection of nursing staff, assigning duties, managing staff schedules and obtaining substitute nurses or providing coverage as needed. Supervises staff to ensure they are meeting students' health needs and assesses performance and quality of nursing services provided through ongoing staff supervision, observations and evaluations. Develops and facilitates appropriate training for nursing and other school staff regarding specialized care and procedures for individual students; may assist with training on other safety and health-related issues. Appropriately documents nursing department and health related activities including compiling and/or preparing, reviewing and/or maintaining accurate written nursing reports, immunization records, health and medical records, including employee new hire and/or annual physicals or forms and reporting of incidents, injuries, etc. Directs the implementation of individualized nursing care plans for each student and ensures or provides special health care and related services through assessment, intervention and follow-up for all children within the school setting, as needed. Collaborates with department directors and/or staff and attends classroom meetings for updates regarding students' health needs, as needed. Participates in student intake meetings, obtaining pertinent medical information from caregivers/parents including diagnoses, medications, emergency interventions and seizure action plans to develop appropriate nursing care plans. Provides direct nursing care including caring for sick and injured students or staff and administers medication or performs prescribed health care procedures according to students' needs and doctors' orders, as needed. Takes the lead in arranging appropriate courses of action for complex or significant health-related incidents and/or managing emergency medical situations involving students or staff. Provides families with health care related updates and information, including referral information and available community resources. Performs all other duties, as assigned. Minimum Qualification Requirements including education, experience, licensure/certification, etc. and essential physical capabilities (e.g. lifting, assisting lifting, standing, etc.) Valid license and current registration as a Registered Nurse issued by the New York State Education Department (NYSED); and Current Basic Life Support (BLS) certification for Healthcare Providers; and Minimum of three (3) years of clinical experience as a RN performing direct care duties ideally in pediatrics and/or with patients with I/DD (multiple disabilities, brain injury/brain-based disorders, etc.) Exhibits exceptional interpersonal, problem solving, communication skills, along with the ability to take initiative, and a highly flexible personality. Preferred Qualification Requirements (desired requirements beyond MQRs above) Bachelor of Science degree in Nursing (BSN) Previous experience as a supervisor of clinical or nursing staff Knowledge of specialized health needs and treatments for children with severe and multiple disabilities Compensation: $105,000-$110,000 Annually

Location: This role enables associates to work virtually full-time, with the exception of required in-person training sessions, providing maximum flexibility and autonomy. This approach promotes productivity, supports work-life integration, and ensures essential face-to-face onboarding and skill development. Alternate locations can be considered. Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law. The **Plan Performance Medical Director** serves as a lead clinician and oversees the administration of medical services for the individual ACA health plans across 17 states. This role involves managing the overall medical policies and clinical guidelines to ensure appropriate and cost-effective care. The Director also leads initiatives to direct the plan regarding cost of care and other strategic directives. Additionally, this position involves collaborating with market plan presidents during meetings with state regulators. **How you will make an impact:** + Supports the Medical Management staff to ensure timely and consistent responses to members and providers. + Provides guidance for clinical operational aspects of a program. + Conducts peer-to-peer clinical reviews with attending physicians or other providers to discuss review determinations, and patients' office visits with providers and external physicians. + May conduct peer-to-peer clinical appeal case reviews with attending physicians or other ordering providers to discuss review determinations. + Interprets existing policies or clinical guidelines and develops new policies based on changes in the healthcare or medical arena. + Leads, develops, directs and implements clinical and non-clinical activities that impact efficient and effective care. + Identifies and develops opportunities for innovation to increase effectiveness and quality. + Provides expertise, captures and shares best practices across regions to other medical directors. + May chair or serve on company committees, may be required to represent the company to external entities and/or serve on external committees. **Minimum Qualifications:** + Requires MD or DO and Board certification approved by one of the following certifying boards is required, where applicable to duties being performed, American Board of Medical Specialties (ABMS) or American Osteopathic Association (AOA). + Requires active unrestricted medical license to practice medicine or a health profession. Unless expressly allowed by state or federal law, or regulation, must be located in a state or territory of the United States when conducting utilization review or an appeals consideration and cannot be located on a US military base, vessel or any embassy located in or outside of the US. Minimum of 10 years of clinical experience; or any combination of education and experience, which would provide an equivalent background. + For URAC accredited areas, the following professional competencies apply: Associates in this role are expected to have strong oral, written and interpersonal communication skills, problem-solving skills, facilitation skills, and analytical skills. Travels to worksite and other locations as necessary. If this job is assigned to any Government Business Division entity, the applicant and incumbent fall under a `sensitive position' work designation and may be subject to additional requirements beyond those associates outside Government Business Divisions. Requirements include but are not limited to more stringent and frequent background checks and/or government clearances, segregation of duties principles, role specific training, monitoring of daily job functions, and sensitive data handling instructions. Associates in these jobs must follow the specific policies, procedures, guidelines, etc. as stated by the Government Business Division in which they are employed. **Preferred Skills, Capabilities and Experiences:** + Experience with clinical finance data, as well as medical cost and trend analysis. + Strong communication skills, including both presentation and writing abilities. + Proficiency in Excel and PowerPoint. For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $262,752 to $450,432. Locations: California, District of Columbia (aka Washington, DC), Illinois, Maryland, Minnesota, Massachusetts, New York, New Jersey, Washington State. In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws _._ * The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.

Job Description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials a BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing an integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies.? They will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 3 design and analyses, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence.? The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional teams.? This position will provide medical insight across a myriad of functions from discovery to manufacturing are expected.? Additionally, the Medical Director will play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training.? Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast-paced and intense environment.???The Medical Director will serve as a leader on one multiple potentially pivotal programs.? Role and Responsibilities: Significant Oncology Experience the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning) Manage direct reports or cross functional team members as needed based on team needs Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations Making vital contributions on pivotal programs in clinical development program? Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals? Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies?? Presentations to various external stakeholders - regulators, governing and harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders? Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review? Planning, reviewing and editing Clinical Study Reports? Planning, reviewing and editing publications from the program Providing input on the design of clinical studies supporting clinical strategy? All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development? Minimum of 5+ years' experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA? Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission The pay range for this role is $283,000-$353,500 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Title: Regional Field Medical Director (Oncology) Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at ********************** and follow our latest news on LinkedIn and Instagram. Job Description: WHAT - Summary & Purpose of the Position Reporting to the Head of Field Medical, the Regional Field Medical Director will lead and manage a team of Medical Science Liaisons (MSLs), driving performance, coaching, and execution of Ipsen's field medical strategy and initiatives within U.S. Medical Affairs (USMA). This role collaborates cross-functionally across USMA to identify, develop, and execute medical strategies and tactical plans. Key responsibilities include but are not limited to delivering scientific insights, developing territory action plans, Though Leader and Healthcare Professionals (TL/HCP) scientific profiling, TL/HCP engagement strategy, digital technology, training, and congress planning. The role will also collaborate with cross functional teams to contribute to business planning, special projects and lead strategic imperatives to support the therapeutic area. Success in this role requires strong strategic medical understanding, business acumen, and exceptional communication skills. The ideal candidate will demonstrate leadership through interpersonal effectiveness, motivation, mentoring, strategic thinking, problem-solving, planning, and organizational skills, and capabilities. WHAT - Main Responsibilities & Technical Competencies People Leadership: Support the recruitment and retention of talent. Direct MSL Team to optimize USMA strategy, field responsibilities, scientific knowledge & performance to support TL/HCP engagements. Provide oversight to employee development, year-end & midyear reviews, expense management & time off. Foster MSL Team culture of innovation, constructive challenge, team spirit & accountability Provide open, candid, & timely performance feedback to direct reports Direct MSL Team on development & implementation of TL engagement plans, profiling & tiering to ensure alignment with Ipsen SOP & Global MSL Policy Manage MSL performance including accomplishments towards USMA Goals & Objectives Evaluate MSL career pathway assessment & employee development planning. Develop MSL Team on executive presence to deliver compliant scientific engagements. Oversee MSL Team territory plans to ensure alignment with USMA Strategy Collaborate with TA MSLs to cultivate & maintain relationships with TL/HCPs Develop a proactive approach to recruitment, staffing & employee retention. Ensure the team performs with the highest ethical standards & compliance with all applicable laws, regulations, industry codes & the Ipsen Code of Conduct. Department Support & Team Development: Participate as an active member of the Medical Affairs Field Leadership team with input into strategic process, development of MSL Team medical goals & objectives. Partner with USMA Trainer to implement MSL TA Training Curriculum Represent MSL function on USMA & cross functional teams. Participate in review & assessment of MSL Global programs to ensure local requirements & standards are fully satisfied. Provide TA oversight of MSL team activities utilizing CRM analytics to monitor progress towards planned Goals & Objectives Interpret VEEVA CRM data to ensure compliant MSL field activities. Provide input on annual budget & resource allocation for TA. Direct TA MSL initiatives across functional areas, including Medical Affairs, Medical Affairs Operations, Research & Development, Clinical Operations, V&A & Commercial Execution of the Medical Field Strategy: Provide oversight of MSL Program that encompasses compliance, quality, performance, scientific standards, professional behavior & role qualifications. Foster team approach to USMA activities that embrace scientific principles & Ipsen's Values Understand & meet needs of product lifecycle management through resource deployment, meeting planning, & customer engagement strategies Manage & coordinate MSL Team meetings to support team building & execution of filed medical plans. Lead development of MSL Goals & Objectives to support Corporate & USMA medical plans. Ensure USMA activities comply with Ipsen business guidance, policies, SOPs, OIG, FDA, & PharMA guidelines Identify opportunities to leverage Global & National resources to positively impact customer scientific needs HOW - Knowledge & Experience Knowledge & Experience (essential): 10+ years' experience in the pharmaceutical industry and/or relevant clinical experience, including at least 5 years in an MSL function. Deep understanding of US PhRMA, OIG, FDA rules and regulations as they apply to MSL activities, with ability to lead a compliant MSL function and related medical engagements. Proven experience managing departmental projects, resources, and cross-functional initiatives. Strong leadership and team management skills, including developing and leading others. Demonstrated ability to develop and maintain strong relationships with TLs/HCPs Excellent verbal and written communication, presentation, and coaching skills Strategic mindset with strong problem-solving and creative reasoning capabilities to identify and provide solutions to various scenarios. Effective interpersonal skills and ability to work across functions, cultures, and diverse teams. Proven project management and matrix team leadership experience, with strong capabilities in tracking, reporting, and optimizing MSL team performance and project outcomes. Strong organizational skills with experience in business planning and managing competing priorities. Strong reasoning & creative solving skills Comfortable working in a fast-paced, dynamic environment with a high level of autonomy Willingness to travel up to 40% and holds a valid driver's license. Education / Certifications (essential): Advanced scientific degree required; doctorate-level clinical/medical degree (e.g., MD, DO, PharmD, PhD, Nursing doctorate) Language(s) (essential): Fluent in English. Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law. Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. The annual base salary range for this position is $212,400-$259,600. This job is eligible to participate in our short-term incentives program as well as our long-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job DescriptionMedical Affairs leader for assigned compound(s) and /or project(s under the leadership of a Sr. GBMD or GMA Franchise head. Major Activities: For assigned compound/indications, work collaboratively across functions, within GPT to execute an integrated Medical Affairs plan including clinical trials, publication, medical education and medical information. Manages all operational aspects and drives execution for assigned projects of Global Medical Affairs clinical trials in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates. Participates and contributes to the joint ICT s. Provides Medical leadership to CTT s for Client sponsored GMA trials Leads review of investigator-sponsored trials and Local/Regional Medical Affairs trials concept sheets, within MRC, for assigned projects(s). Provides medical support for educational events (e.g. stand-alone meetings, scientific symposia) and scientific congresses within legal and compliance regulations. Collaborates across functions to achieve approval of key scientific communications, medical information documents and commercial documents within NP4 legal and compliance regulations. Skills: Fluent oral and written English. Have expert operational knowledge and experience in clinical trial design and all stages of clinical trial conduct (Trial design, Start-up, Execution, Analysis, Reporting). Have an excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area. Have strong knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products. 5 years experience in pharma at local, regional and/or Global level. Provide medical expertise to ensure successful product launches across functions. NVS sponsored trials Review and coordinate IITs Implement patient access programs Review promotional materials & publications Integrate medical expertise with commercial perspective. Maintain an external focus to optimize and maximize treatment options and compound life cycle management. Timely implementation and delivery of high quality Medical affairs clinical programs within budget, in full compliance with Client Standard and GCP/ICH. Well managed and effective clinical teams. External satisfaction, acceptability of clinical data by key decision makers including health authorities, payers. Development of high-quality scientific communications and medical information. Strong alignment between Global and Regional/local medical organizations. Strong alignment within global line functions. More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred. QualificationsEducation: MD Required More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred Additional InformationNeha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Website: ******************

Job Description At Moxie, we empower ambitious aesthetic entrepreneurs to build profitable, independent practices-without burnout, overwhelm, or guesswork. In just a few years, we've grown from an idea to a global, remote-first team of more than 140 people, supporting hundreds of practices nationwide. Our purpose is simple: to unlock sustainable success for aesthetic entrepreneurs, at every stage of their journey. **Must reside or have a primary office in New York, and hold an active NY license. We work with talented nurse injectors to empower them to build independent businesses. We help connect Medical Directors to RN, NP, and PA providers, to provide insight into state regulations and standards of care. Our providers work through our software platform which streamlines administrative tasks to allow you to focus on medical partnership. Review SOPs, consent forms, charts, etc. Be on call in case of emergency Provide general supervision according to state law Once vetted, you will interview and choose to partner with the injectors of your choice, at the rates you set. You can work with as many injectors as you choose and state law permits. Requirements: MD or DO with an active state license Minimum of 1 year of experience in medical aesthetics and/or medspa settings Minimum of 1 year of experience providing medical oversight, such as serving as a Medical Director or Collaborating/Supervising Physician Formal Training in injectables and other aesthetic services. A resident of the state of New York or New Jersey Benefits: Pay & Perks Competitive compensation Liability is covered Other Info: This is a PC owner position - Moxie manages everything on your behalf for the PC Experience in either Dermatology, Plastic Surgery, Ophthalmology, or Oculoplastic Surgery is a plus We're specifically looking for Medical Directors licensed to practice in NY. At Moxie, we believe in creating a workplace where everyone feels valued, trusted, and included. Our team lives by our values: act as owners, give more than we take, move with speed and care, and simplify and learn every day. We welcome people of all backgrounds, experiences, and perspectives to apply. If you require any accommodations to fully participate in the interview process, please let us know, we're happy to assist.

Join BoldAge PACE and Make a Difference! Why work with us? A People First Environment: We make what is important to those we serve important to us. Make an Impact: Enhance the quality of life for seniors. Professional Growth: Access to training and career development. Competitive Compensation: Medical/Dental Paid Time Off 240 Hours Annually* 401K with Match** Life Insurance Tuition Reimbursement Flexible Spending Account Employee Assistance Program BE PART OF OUR MISSION! Are you passionate about helping older adults live meaningful, independent lives at home with grace and dignity? BoldAge PACE is an all-inclusive program of care, personalized to meet the individual health and well-being needs of our participants. Our approach is simple: We listen to our participants and their caregivers to truly understand their needs and desires. Medical Director JOB SUMMARY: The Medical Director provides general medical direction and supervision of the medical aspects of care for participants. The Medical Director is responsible for the delivery and oversight of participant care, clinical outcomes, implementation and oversight of the quality assessment and performance improvement program, development and maintenance of medical policies and procedures/standards and protocols. The Medical Director will provide direction and supervision to primary care physicians, nurse practitioners, nursing staff and allied health services and leadership of the program among staff, colleagues and providers in the community. Any PCP Nurse Practitioners will practice collaboratively with the Medical Director or PCP Physician. Responsible for ensuring a managed care environment that utilizes resources efficiently and effectively. ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for delivery of care and clinical outcomes. Provides medical guidance and supervision of medical services activities. Provides leadership and medical expertise in the development of medical policies, procedures and guidelines. Responsible for the development of PACE clinical standards and medical practice guidelines and protocols. Provides oversight of the QI Plan. Reviews all quality-of-care issues and oversees the development and implementation of quality of care corrective action plans. Participates in the oversight, training and education of the interdisciplinary team. Coordinates performance appraisal of the Primary Care Physician. Develops educational and other programs to build the skills of participating providers. In conjunction with Contract Manager manages all communication with the provider network Represents PACE to external agencies, professional groups and regulatory agencies and organizations as required. Demonstrates necessary skills and knowledge as outlined in position-specific competency requirements. REQUIREMENTS: M.D. or DO with current state of license. DEA registration and the ability to obtain and maintain staff privileges at PACE contracted agencies. Board certified in Internal Medicine or Family Practice with advanced certification in geriatrics preferred. Must have experience working in a managed care environment and working with peers and other health providers to resolve utilization, quality management, performance improvement, pharmacy and therapeutics, peer review, credentialing, and physician leadership issues. Minimum 3 years of experience in a lead administrative role. 1 year of experience working with a frail or elderly population preferred. If this is not present, training on working with a frail or elderly population will be provided upon hiring. Must have reliable transportation, a valid driver's license, and the minimum state required liability auto insurance. Be medically cleared for communicable diseases and have all immunizations up to date before engaging in direct participant contact. Pass a comprehensive criminal background check that may include, but is not limited to, federal and state Medicare/Medicaid exclusion lists, criminal history, education verification, license verification, reference check, and drug screen. SKILLS AND ABILITIES: Excellent verbal, written and public speaking skills. Knowledge of physical, mental and social needs of frail older adults. Effective skills in physical assessment and chronic disease management for frail older adults. Able to work within the interdisciplinary team setting. Able to utilize basic computer skills in the workplace. Strong organizational skills. Demonstrates necessary skills and knowledge as outlined in position-specific competency requirements. Dependable, flexible and resourceful Able to work effectively and in a collegial manner will all members of the management and medical staff. Able to work sensitively and effectively with individuals of diverse ethnic and cultural backgrounds. BoldAge PACE provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. *Paid Time Off Includes seven holidays ** Match begins after one year of employment Full-Time Days Full- Time

Medical Director Veterinarian The Pet Doctor - Flushing, NY Ownership/Equity Opportunity Available! The Pet Doctor, a well-established small animal practice in Flushing, New York, is seeking an experienced, confident veterinarian to step into a Medical Director role. This is an excellent opportunity for a veterinarian who enjoys clinical leadership, team development, and practicing high-quality medicine in a diverse, fast-paced community. This position is not suitable for new graduates. We are seeking a veterinarian with several years of clinical experience who is comfortable practicing independently and leading a medical team. Why The Pet Doctor? * Established, community-trusted practice * Supportive, experienced staff * Opportunity to shape the medical direction of the hospital * Competitive compensation commensurate with experience * Leadership role with professional autonomy Why Flushing, NY? Flushing is one of New York City's most vibrant and culturally rich neighborhoods, making it an exciting destination for veterinarians relocating from out of state. Highlights include: * Easy access to Manhattan via public transportation * Minutes from LaGuardia Airport and close to JFK * World-class dining and diverse cuisine * Flushing Meadows-Corona Park, one of NYC's largest green spaces * Urban energy with nearby suburban living options in Queens and Long Island * Arts, culture, sports, and entertainment at your doorstep Flushing offers the perfect balance of career growth, cultural richness, and city convenience, whether you're looking to build a long-term home or enjoy everything NYC has to offer. Ready to Lead? If you are an experienced veterinarian looking for a leadership role in a dynamic, well-established practice, we would love to hear from you. Apply today to join The Pet Doctor in Flushing, NY. Job Description As Medical Director, you will: * Provide high-quality medical and surgical care to a loyal client base * Lead and support the veterinary team with confidence and professionalism * Establish and uphold medical standards and protocols * Collaborate with management on hospital operations and growth * Serve as a clinical mentor to support staff and promote a positive workplace culture What We're Looking For * DVM or VMD degree from an accredited veterinary school * Several years of clinical experience in small animal medicine (required) * Strong diagnostic, surgical, and communication skills * Leadership experience or interest in a Medical Director role * Licensed (or eligible for licensure) in New York State Qualifications * Doctor of Veterinary Medicine (DVM) degree or equivalent from an accredited university * Active Veterinary State License (or ability to obtain upon hire) * Current DEA License (or ability to obtain upon hire) * USDA Accreditation (or ability to obtain upon hire) Additional Information WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin Pay is customizable and based on experience and/or potential for bonuses. A general range for a base salary is $130,000 - $190,000 DOE and compensation package. #IND3

Who we are: Raritan Animal Hospital is seeking a dedicated and visionary Chief of Staff to lead our medical team and ensure the continued delivery of high-quality veterinary care. We are a thriving, community-centered practice consisting of a full-service main hospital supported by three outpatient clinics. This structure allows us to offer convenient access and continuity of care while maintaining the highest medical standards. We work closely with board-certified internal medicine, surgery, and cardiology specialists to provide advanced diagnostics and treatment options for our patients. Our facilities include: A well-equipped main hospital with modern amenities including an in-house labs, digital radiography, complete dental suite with dental radiography, newly renovated surgery suite with comprehensive monitoring systems and radiowave surgery A skilled, well-trained team of technicians who provide outstanding support to our doctors Beyond medicine, we're proud of our fun, inclusive, and community-focused culture. Our team enjoys events like Halloween costume contests, pictures with Santa, in-clinic egg hunts, and regular in-house CE opportunities that support ongoing learning and collaboration. What We're Looking For: Provide visionary oversight of all clinical care, ensuring outstanding patient outcomes and adherence to gold-standard medical practices. Champion new technologies and medical advancements to continually elevate our standard of care. Inspire and mentor associate and new graduate veterinarians through case collaboration and professional development. Foster a supportive and communicative team culture grounded in respect, collaboration, and growth. Cultivate strong client relationships with visibility, approachability, and excellent communication skills. Support initiatives that enhance client satisfaction, loyalty, and the hospital's well-earned reputation for compassionate care. What's in it for you: Vetcor offers a comprehensive benefits package that supports your well-being and professional growth. Enjoy medical, dental, and vision insurance, a 401(k) with company match, generous paid time off, CE allowance, paid parental leave, and access to a vast network of veterinary professionals. We also offer mental health support, employee discounts, and a culture that truly values work-life balance. Ready to connect? Email Kaley at *****************! Job Title: Chief of Staff Location: Raritan Animal Hospital Salary Range: $175,000 - $200,000 + Production Bonus (No Negative Accrual!) Our practice has a positive, well-being focused culture that we'd love to tell you about. Where we are: Edison, New Jersey is a vibrant, diverse township located in central New Jersey, just 30 miles from New York City. Known for its rich history-it's the home of Thomas Edison's famous Menlo Park lab-Edison offers a blend of suburban comfort, excellent schools, and easy access to major highways and public transit. With bustling shopping centers, parks, and a strong sense of community, it's a great place to live, work, and explore.

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description Accountable for deliverables of the Global Medical Affairs function, including expert review and evaluation of Benefits and Risk for RX to OTC switch products. Deliver Medical rationale, benefit/efficacy, core science summaries in support of Regulatory Submissions. Engage with external medical and scientific leaders in support of medical strategy. Skills: 1. Critical thinking in order to support application of scientific literature to solve 2. Ability to work on complex projects with highly-matrixed teams 3. Facilitate debate and conclusions to drive high quality, innovative project deliverables Additional Information Thanks and Regards, Isha Sharma 408-766-0000- EXT 425 isha.sharma@)usitsol.com

**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each day. **About the Role** The Omnichannel Center of Excellence is dedicated to driving innovation, building, and delivering capabilities that enhance Otsuka's opportunity to make an impact in the lives of those we serve. We achieve this through our relentless focus on customer centricity, patient empathy, expertise in enabling pathways for disease education and awareness of management options, and our unwavering commitment to supporting access to treatment. We are looking for an **Omnichannel Data Scientist** , **Medical Omnichannel** with strong expertise in artificial intelligence, encompassing machine learning, data mining, and information retrieval. This position specifically entails the conceptualization, prototyping and development of next generation advanced analytics model-based decision engines and services. The ideal candidate will engage closely with key stakeholders to understand strategic objectives and leverage advanced data analytics and machine learning techniques to enhance communication strategies, ensuring seamless and personalized interactions with healthcare professionals (HCPs) and key opinion leaders (KOLs). **Job Expectations/Responsibilities:** **Data Integration & Management** + Explore and analyze common pharmaceuticals data (e.g., claims) as well as novel data sets based on lab and EHR systems. Work with Omnichannel Data Engineer to Integrate data from multiple sources (e.g., CRM systems, social media, email platforms) to create a unified view of stakeholder interactions. + Apply natural language processing (NLP) to extract insights from unstructured medical texts, such as clinical notes or call center transcripts. + Identifying relevant data drivers (features) that can inform decision making closely tied with strategy and creating visualizations to help communicate findings. **Advanced Analytics & Modeling** + Implement advanced analytics models, including predictive analytics and clustering algorithms, to generate actionable insights and track trends across various channels. + Work with Omnichannel ML/Ops engineer to build, test, and deploy production-grade predictive models and algorithms as part of the Omnichannel COE decision engine to meet business needs, including optimization of sales activities and predicting drivers of customer behavior. + Create repeatable, interpretable, dynamic, and scalable models that are seamlessly incorporated into analytic data products and match the needs of Otsuka's growing portfolio. + Collaborate on MLOPS life cycle experience with MLOPS workflows traceability and versioning of datasets. Build and maintain familiarity with Otsuka Machine Learning tech stack including AWS, Kubernetes, Snowflake, and Dataiku **Omnichannel Optimization** + Design and deploy recommendation systems to tailor communications based on stakeholder preferences and behaviors. Utilize machine learning algorithms (e.g., collaborative filtering, content-based filtering) to enhance personalization efforts. + Analyze the performance of omnichannel campaigns (email, SMS, in-app, HCP portals, etc.) to identify high-impact touchpoints and optimize engagement strategies. Use A/B testing and uplift modeling to evaluate the effectiveness of different communication strategies and content types. **Stakeholder Collaboration** + Effectively communicating analytical approach to address strategic objectives to business partners. + Work closely with medical affairs, marketing, and IT teams to ensure alignment and integration of omnichannel strategies. Provide technical guidance and support to cross-functional teams on data-related projects. + Stay updated with emerging industrial trends (Conferences and community engagement) and develop strategic industry partnerships on Omnichannel analytics to strengthen Otsuka's analytical methods and outcomes. + Model Otsuka's core competencies (Accountability for Results, Strategic Thinking & Problem Solving, Patient & Customer Centricity, Impact Communications, Respectful Collaboration & Empowered Development) that define how we work together at Otsuka. Key matrixed partners included: Brand Marketing, Creative / CRM / Digital agencies, Media, Market Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/Regulatory/Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree in data sciences, computer science and 4-6 years of relevant experience **Preferred Knowledge, Skills, and Abilities:** + Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling and simulation software (e.g. Python, Matlab, R, NONMEM, SAS, S-Plus, etc.) is a plus. + Knowledge/Experience in the usage of machine learning/AI tools in life science area(s) and handling life science datasets is preferred. + Excellent interpersonal, technical, and communication skills to lead cross-functional teams. + Profound grasp of Machine Learning lifecycle - feature engineering, training, validation, scaling, deployment, scoring, monitoring, and feedback loop. + Have implemented machine learning projects from initiation through completion with particular focus on automated deployment and ensuring optimized performance. + Agile skills and experience + Experience in Healthcare (esp. US) industry is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities · Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). · Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. · Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. · Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. · Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. · Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. · Liaise with global and regional medical affairs colleagues as appropriate. · Provide strong scientific support for conference and booth coverage. · Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. · Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. · Provide mentoring, guidance, and training to new hires/less experienced colleagues. · May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. Qualifications: · Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. · Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. · Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) · Practical experience and knowledge of FDA guidances on appropriate scientific exchange practices. · Previous experience of managing/leading teams directly/indirectly or coaching and mentoring new hires/less experienced colleagues. · Proficiency with Microsoft Office Suite software, SharePoint, Veeva, customer relationship management software, and other technology and telephony systems. Additional Preferred Qualifications: · Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. · Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. · Strong understanding of data visualization and insights reporting to support strategic decision-making. · Able to travel as needed (approximately 10% on average). · This role is hybrid in Nutley, NJ (in office every week on Tuesday, Wednesday, and Thursday) Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Medical Information, Oncology is from :$162,600-$213,400Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! We are looking for a highly motivated, independent and talented Associate Director of Medical Writing. In this role, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As Associate Director of Medical Writing, you will be responsible for contributing to the medical writing portfolio within the clinical and regulatory areas. This includes authoring briefing documents, clinical trial medical synopses, protocols, investigator's brochures, PIPs, CSRs, Health Authority briefing books, Health Authority responses, and other clinical documentation to support the conduct of trials and regulatory submissions/filings. The Associate Director participates in the development of templates and the establishment of medical writing processes and standards to ensure the quality and timeliness of regulatory filings and clinical documentation, in accordance with relevant regulatory guidelines and requirements. The Associate Director proactively leads departmental activities and various process improvement initiatives, and shares insights from lessons learned. Your key responsibilities will be: Key Accountabilities * Independently author and review complex clinical and regulatory documents, including clinical trial protocols, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions. * Draft and edit more strategic documents, such as Health Authority briefing books, responses, and publications (abstracts, posters, slide presentations, and manuscripts for scientific journals). * Represent medical writing on internal teams such as the Clinical Trial Team, protocol review committee, and regulatory submission teams. * Lead submission team activities and oversee the preparation of critical documents. * Facilitate team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews and decisions. * Act as a mentor for new employees and consultants and serve as a role model for junior writers. * Lead the development and review of standard processes and templates. * Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge. * Lead the development and review of standard processes and templates. * Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge. * Lead the development and review of standard processes and templates. * Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge. Skills and experience * Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field preferred; advanced degree preferred. * At least 8 years relevant medical or scientific writing experience in the pharmaceutical industry. Oncology experience preferred. * Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTA/IND submissions, investigator's brochures, plans required for the conduct of clinical trials, and clinical trial data collection and results reporting. * Experience authoring clinical trial protocols (Phase 1-3) and clinical components in regulatory filings (NDA, BLA, MAA) is required. Additionally, experience preparing investigator's brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. * Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates. * General understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports). * Ability to interpret and summarize tabular and graphical data presentations. Moreover, you meet the following personal requirements: * Strategic thinker with a big-picture orientation. * Thorough, systematic, and organized. * Proactive, accountable, and goal oriented. * Innovative and a good team player. * Excellent at sharing knowledge and acting as a mentor. * Superior communication skills, capable of conveying scientific or medical information clearly and concisely. * Exceptional planning and coordinating abilities. * Ability to manage multiple tasks simultaneously. * Extensive knowledge of English grammar. * Expert in Microsoft 365. * Analytical skills with the ability to interpret and present clinical data and other complex information. * Advanced leadership skills to guide and mentor team members. * Expertise in managing complex projects and submissions. * Strong influence and representation skills in high-level cross-functional teams. * Strategic vision to drive departmental goals and initiatives. * High level of knowledge of regulatory requirements and compliance For US based candidates, the proposed salary band for this position is as follows: $160,080.00---$240,120.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: * 401(k) Plan: 100% match on the first 6% of contributions * Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance * Voluntary Plans: Critical illness, accident, and hospital indemnity insurance * Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave * Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support * Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You * You are genuinely passionate about our purpose * You bring precision and excellence to all that you do * You believe in our rooted-in-science approach to problem-solving * You are a generous collaborator who can work in teams with a broad spectrum of backgrounds * You take pride in enabling the best work of others on the team * You can grapple with the unknown and be innovative * You have experience working in a fast-growing, dynamic company (or a strong desire to) * You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com). Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance as part of the Clinical Development Team working in Somerset, NJ. Role Overview The Sr. Medical Director, Drug Safety & Pharmacovigilance is a critical role in the company with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise and guidance to the clinical development and project team for the assigned products. The Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Key Responsibilities Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals. Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information. Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings. Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects. Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)) Identification and management of Urgent Safety Measures with support of cross functional team. Overview, and/or author aggregate reports and signal evaluation reports for assigned projects. Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics. Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight. Oversee and manage internal safety scientist and safety operation team. Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals. Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.) Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed. Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership. Prepare/oversee monthly progress reports and ad-hoc reports as required Support process improvement and functional training at departmental & company level Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations Requirements MD or MBBS or MD-PhD or equivalent medical degree 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance. Strong understanding of pharmacovigilance regulations in the US and EU. Experience in supporting drug safety activities in registrational clinical studies High level of medical competence, with an ability to balance this with industry standards to achieve business goals Demonstrated skills in scientific analysis and reasoning. Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance. Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable Strong track record of delivering results through effective team and peer leadership in matrix Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.) Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies. Experience in biotech - preferred but not required. #Li-LB1 #Li-Hybrid The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$285,906-$375,253 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us. Remote Employee Value Proposition: At Taiho Oncology, we are driven by our mission to improve the lives of cancer patients. As an Associate Director, Medical Writing, you will work on various document types and play a critical role in transforming scientific data into compelling narratives that contribute to innovative cancer treatments. Join a dedicated team that fosters a collaborative, patient-first environment, where your expertise and passion will directly impact patient care and advance oncology research. We believe in empowering our employees through continuous learning, career development, and a supportive culture that values diverse perspectives and encourages innovation. If you are ready to take on new challenges and make a meaningful difference, Taiho Oncology offers you the opportunity to grow, excel, and be a part of something bigger. Together, we are relentless in our pursuit of better cancer treatments. Join us in putting patients at the heart of everything we do. Position Summary: The incumbent is responsible for authoring Taiho Oncology, Inc., (TOI), documents submitted to Regulatory Authorities including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and relevant summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions for drugs in line with regulatory requirements and internal standard operating procedures. Performance Objectives: Responsible for authoring TOI documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions. Prepare documents in line with regulatory requirements in conjunction with Regulatory Affairs and with internal standard operating procedures in a timely and accurate manner. Understand publishing standards for FDA and MAA. Manages and oversees medical writing deliverables assigned to internal and contract writers or other third party vendors. Represent Global Medical Writing department on clinical development cross-functional teams and project initiatives. Develop and implement medical writing processes in line with SOPs. Prepares project and/or status reports. Proficient in Microsoft applications and document management systems. Education/Certification Requirements: Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred. Knowledge, Skills, and Abilities: Minimum of 8 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents. Extensive previous experience in Medical Writing in clinical drug development, preferably some experience in oncology. Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations. Knowledge of template development, document management systems and requirements Experience developing and implementing medical writing processes for all stages of clinical development. Strong working knowledge of medical writing requirements and document components. Good interpersonal skills that involves working well in a team environment and the ability to lead others. Good organizational and planning skills; drive for results. Ability to read, analyze and interpret scientific and technical information. Effective analytical/problem solving skills. The pay range for this position at commencement of employment is expected to be between $194,650 - $229,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-Remote

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG. Job Description Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues. KEY RESPONSIBILITIES As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety Provides oversight of medical safety evaluation for assigned global investigational products Coordinates and contributes to medical assessment for assigned global post-marketing products Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation. Partner with relevant internal and/or external experts to fulfill responsibilities Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities. Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate) Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs Oversees development and preparation of Risk Management Actions Plans for regulatory filings Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department. Qualifications Education: Medical Degree (MD or DO), and current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience Professional Experience: Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Ability to travel domestically & internationally as required, typically up to 30% Knowledge and Skills: Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines) Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Demonstrated authorship of PSUR, REMS or RMP, and DSUR Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion Experience with ARISg or other safety database programs Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

EmTacq specializes in EM ployer T alent ACQ uisitions, matching the most qualified candidates with the most competitive positions available. We pride ourselves on not just putting bodies in seats, rather matching professionals to their careers. We are headquartered in the Raleigh / Durham, NC area. However, as a recruiting agency we service companies and candidates across the United States. We are your best source for professional, value driven low cost recruitment services. Our primary focus is providing a one-on-one recruiter relationship and provide top Direct hire performers to our clients. Our goal is to make each hiring experience simple and successful. We want to be your “Employment Partner" and are excited to assist you with all your employment needs. We look forward to building and maintaining a solid relationship. Our MISSION STATEMENT is to provide "Personnel Services with a Personal Touch". Our philosophy is to employ only the best, skilled candidates to create the perfect "fit" for each client. We follow that up with unsurpassed customer service. Job Description This medical writing expert role will assume overall responsibility for directing the development and implementation of the medical communication strategy for all regulatory submission documents for all assigned drug projects and work with assigned Senior Medical Writers and Submission team experts in developing and implementing the submission authoring strategy for all clinical sections. Qualifications An advanced Degree in Science 8+ years of experience in the pharmaceutical industry 6+ years of experience in regulatory medical writing involving all clinical document types in more than one therapeutic area. Must have experience in electronic document management and electronic regulatory submissions, tools and standards. Strong leadership experience and the ability to mentor Excellent verbal and written communication skills Some travel may be required. Additional Information Must be a US citizen or Green Card holder. All your information will be kept confidential according to EEO guidelines.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG. Job Description Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues. KEY RESPONSIBILITIES As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety Provides oversight of medical safety evaluation for assigned global investigational products Coordinates and contributes to medical assessment for assigned global post-marketing products Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation. Partner with relevant internal and/or external experts to fulfill responsibilities Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities. Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate) Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs Oversees development and preparation of Risk Management Actions Plans for regulatory filings Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department. Qualifications Education: Medical Degree (MD or DO), and current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience Professional Experience: Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Ability to travel domestically & internationally as required, typically up to 30% Knowledge and Skills: Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines) Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Demonstrated authorship of PSUR, REMS or RMP, and DSUR Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion Experience with ARISg or other safety database programs Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: