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Takeda Pharmaceuticals U.S.A., Inc. Jobs

- 565 Jobs
  • Director, Global Regulatory Lead, GI & Inflammation

    Takeda 4.7company rating

    Takeda Job In Cambridge, MA Or Remote

    About the role: The Global Regulatory Leads, Director ensures that Takeda gains regulatory approval for new products and product amendments while maintaining the currency of product licenses and permits. This role involves developing and implementing regulatory strategies, managing compliance projects, and leading multidisciplinary teams to achieve organizational goals. Skills and qualifications: Develops and implements regulatory strategies to ensure compliance with global standards Manages complex compliance projects, ensuring alignment with organizational goals Leads multidisciplinary teams, providing direction and support to achieve project objectives Coordinates and oversees project management activities, ensuring timely completion of tasks Applies problem-solving skills to anticipate and address challenges in regulatory processes Communicates effectively with stakeholders at all levels, including government officials Plans and executes long-term strategic plans aligned with global regulatory requirements Manages risks associated with regulatory affairs and compliance Engages with stakeholders to ensure their needs are met and to foster collaborative relationships Identifies and implements process improvements to enhance regulatory operations Utilizes analytical skills to assess regulatory landscapes and make informed decisions Makes critical decisions under pressure, ensuring the integrity and accuracy of regulatory submissions Accountabilities: The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: Bachelor's Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as “hybrid” in accordance with Takeda's Hybrid and Remote Work policy.
    $168k-235k yearly est. 24d ago
  • Regional Business Specialist - GI (AZ and Las Vegas)

    Takeda Pharmaceuticals 4.7company rating

    Takeda Pharmaceuticals Job In Washington, DC

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **About the role:** Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Regional Business Specialist in our Phoenix - Las Vegas territory. Here, everyone matters, and you will be an important contributor to our inspiring, bold mission. As a Regional Business Specialist, you will be responsible for driving the demand for the product assigned by reinforcing the product brand and Takeda value. To achieve this, you will be responsible for presenting Takeda's products and optimizing the business opportunities in targeted physician offices, key clinics and hospital accounts. **How you will contribute:** + Support account on-boarding, including education, and procedures. + Engage in clinical selling activities, including delivering the clinical value proposition, advancing customers across a brand belief continuum. + Support initial clinical educational support and in-service for medical staff. + Coordinate and support clinical education opportunities and programs for HCPs, such as peer-to-peer discussions. + Conduct account management activities within the smaller, less complex: GI practices, clinics and outlets as well as independent physician offices. + Attains sales goals and objectives by delivering specialty product volume as well as other key metrics in the assigned Territory. Utilize discretion and judgment to execute the franchise and company brand strategy and tactics within the assigned customer segment, which may include physicians within specialty medical practices and their staff, specialists within local hospitals, clinics, and support staff as well as pharmacists within a specific geographic area. + Establish professional working relationships with Health Care Providers decision makers, support staff, and influencers within assigned customers, to support the use of the company's products - through developing and applying clinical and business expertise, and effective selling skills. + Develop and deliver a targeted sales message based on accurate clinical information, utilizing approved marketing materials and medical reprints to support the patients, and discuss therapeutic strategies to inform and influence decision makers. + Executes marketing strategies at the local level, leveraging resources appropriately and working successfully with company team members and counterparts to share ideas and information to enhance business results. + Be accountable to build customer engagement by identifying and cultivating relationships with key decision makers at the local level who can influence decision making within the healthcare provider systems and specialty medical practices. + Presents complex clinical and business information on Takeda's specialty products and services to an audience of office and institutional based Gastroenterologists health care professionals, professional and patient groups, and others involved in the decision-making process. + Develop and implement medical education opportunities and sponsor programs to expand the knowledge of healthcare professionals. Frequently educate self on the latest information related to disease states, treatments and the changing business environment. + Strategically manages all allocated resources provided including financial/budgets, managed markets, medical affairs, home office, etc. **Minimum** **Requirements/Qualifications:** + Bachelor's degree - BA/BS + A minimum of 3 years direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry and/or relevant clinical or industry experience + Discussing therapeutic strategies to inform and influence decision makers + Developing and applying clinical and business expertise, and effective selling skills + Executing marketing strategies at the local level + Strong collaboration working within teams + Demonstrated business and strategic planning skills to identify unique selling opportunities and adaptability to changing market conditions + Demonstrated understanding of managed care landscape and how it influences/impacts business + Strong verbal, influencing, presentation and written communication skills + Strong collaboration skills and success working in teams + Reside within or close proximity to assigned geography Preferred: + Experience with managing and communicating complex reimbursement issues + Experience calling on Gastroenterologists **Licenses/Certifications** + Valid Driver's License **TRAINING REQUIREMENTS:** This position and continued employment is contingent upon the employee successfully passing mandatory product training which includes written and oral examinations. External Takeda Hires Only: During that training period, the employee will be classified as a non-exempt employee and will be eligible for overtime during the training period only in accordance with applicable federal and/or state law but the employee will not be eligible for any Takeda related sales incentive programs and/or other production based bonuses. The training period will consist of live instruction, independent study, role play, and other training related activities which should take no more than 8 hours per day and 40 hours total in a workweek. After successful passage of the mandatory product training examinations, the employee will be transitioned to exempt status and will no longer be eligible for overtime. They will then be paid on a bi-weekly basis and eligible to participate in various Takeda related sales incentive programs and/or contests. **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - AZ - Virtual **U.S. Hourly Wage Range:** $54.62 - $75.10 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - AZ - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** No \#LI-Remote
    $54.6-75.1 hourly 3d ago
  • Global Safety Program Lead

    Astrazeneca 4.6company rating

    Gaithersburg, MD Job

    This is what you will do: The Global Safety Program Lead is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); the professional will work with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level. Acts strategically to generate opportunity and value for the asset or indication to optimize benefit risk and maintain a competitive advantage. Line manages a team of safety physicians and / or scientists. They will be required at times to deputise for the Global Safety Head. The Global Safety Program Lead will operate according to the highest ethical, quality and compliance standards in compliance as provided by global and local regulations, GxP practice and AZ procedures. You will be responsible for: Safety Expert Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications. Accountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s). Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy. For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH. Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s). Leads response to complex technical issues for specific safety aspects for the assigned asset(s). Is accountable for safety contribution to study designs and study concept delivery within their assigned program Through integrated understanding of the product strategy, provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s). Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset. Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards. Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team. May be required to support in-licensing opportunities. Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours Accountable for implementation of new processes, systems and learning, including new ways of working. Prioritizes risk mitigation strategies and effective trouble shooting. Line manages a team of safety physicians and / or scientists. Scientific clinical safety analytical accountabilities Maintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information, Accountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally Delivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals. Serves as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data. You will need to have: Medical degree or equivalent degree in biomedicine or science 5 years extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs. Ability to collaborate across a matrixed environment and influence cross-functional- leaders on decision-making (e.g. Clinical Development, Medical Affairs, Regulatory Affairs). Thorough knowledge and understanding of pharmacovigilance & safety deliverables, standards and processes at a global level; including pre and post launch experience. Experience of global regulatory submissions and interacting with major regulatory agencies. Demonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists. Available to travel domestically and internationally Demonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement. We would prefer for you to have: PhD (or other complementary degree) in scientific discipline. Excellent, independent judgment based on leading-edge knowledge and expertise. Excellent speaking skills, industry conference speaking experience. Excellent, independent judgment based on knowledge and expertise. Demonstrated clinical safety and research expertise in an appropriate disease area. The annual base pay (or hourly rate of compensation) for this position ranges from $211,343 to $317,014. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an 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 pay (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. Date Posted 07-Feb-2025 Closing Date 06-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
    $211.3k-317k yearly 9d ago
  • Senior Medical Director, Principal Patient Safety Physician - Oncology

    Astrazeneca 4.6company rating

    Gaithersburg, MD Job

    Are you ready to bring your deep clinical understanding and judgement to a senior leadership role within Patient Safety at AstraZeneca? As a Senior Medical Director, Principal Patient Safety Physician, you will play a pivotal role in shaping the culture of our department and mentoring our junior staff. Your expertise will ensure our projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. Are you up for the challenge? When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. What you'll do In this role, you will be responsible for providing strategic Patient Safety input to drug development and post-marketing programs. You will collaborate with team members to undertake safety surveillance activities and prepare high-quality evaluation documents to describe safety findings. You will also ensure experienced input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation). You will provide leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee. You will lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities. Lastly, you will lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs. More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external collaborators. Essential for the role Degree in medicine and experience as a physician or academic clinician Extensive experience in Pharmacovigilance, with clear evidence of delivering to a high standard Detailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency Experience in designing, monitoring and implementing clinical trials and interpreting trial results Strategic leadership of complex drug projects Understanding of the medico-legal aspects of pharmacovigilance Shown leader of cross-functional delivery teams. Demonstrated ability to influence key business partners within and outside of company Proficiency with both written and verbal communications Desirable for the role PhD in scientific field Therapeutic area expertise and commercial understanding Extensive general medical knowledge Able to work across TAs and Functions Research background, including peer reviewed publications Why AstraZeneca At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare. So, what's next Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. The annual base pay (or hourly rate of compensation) for this position ranges from $265,781 to $398,671. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an 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 pay (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. Date Posted 12-Dec-2024 Closing Date 30-Mar-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
    $265.8k-398.7k yearly 10d ago
  • UX Design Director

    Astrazeneca Pharmaceuticals LP Company 4.6company rating

    Gaithersburg, MD Job

    About AstraZeneca At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. We are united by our shared passion for innovation and our unwavering focus on making a difference in the lives of patients worldwide. Join us in shaping the future of healthcare through cutting-edge technology, design, and user experience. Role Summary AstraZeneca is looking for a Product Design Director with exceptional design, communication and people management skills. As a Product Design Director, you will lead and manage a team to drive exceptional design solutions that enhance the experience for patients, healthcare professionals, employees, and other stakeholders. In this role, you'll be a foundational member on the UX leadership team, working together with your counterparts to define the strategy, operations and communications that guide the team to deliver great seamless experiences across our tools and products. You'll be expected to utilize your full range of people management skills, product strategy, product design, interaction design and visual design skills. Key Responsibilities Build and manage a talented, diverse, inclusive team of product designers that consistently delivers on projects and is well-balanced across a range of design skill sets. Drive collaboration and vision across the team and enterprise to build alignment on priorities leading to product design and execution. Help shape the product roadmap, both short term and long-term. Partner closely with a global team of partners and stakeholders to deliver high quality experiences for employees and patients across markets, tools and platforms. Oversee multiple projects and scale design resources accordingly, ensuring deadlines are met, your org is effective, and team members are set up for success by setting clear and measurable goals. Develop design talent and build a thriving culture where designers grow in their careers and feel a strong sense of inclusion and belonging. Design and scale the organization and equip the team for success in their goals. Foster a strong, collaborative design practice. Minimum Qualifications 10+ years of experience in Product Design or related field 6+ years of leadership experience with direct reports under your guidance and leadership, including hiring and developing both junior and senior individual contributors Senior people management, team development, recruiting and org building experience Experience growing a strategic design practice within design teams Visual and interaction experience in software design Organizational and analytical experience In-Office Expectation: When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The annual base pay (or hourly rate of compensation) for this position ranges from $159 369 - $239 054. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an 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 pay (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. Date Posted 29-jan.-2025 Closing Date 18-feb.-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
    $159.4k-239.1k yearly 16d ago
  • Pharmaceutical Sales Specialist, Advanced Specialty Care- Respiratory Biologics (Arlington, VA)

    Astrazeneca 4.6company rating

    Arlington, VA Job

    At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Pharmaceutical Sales Specialist, Advanced Specialty Care-Respiratory Biologics - Arlington, VA, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Respiratory disease is one of AstraZeneca's main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. Accountabilities: Develop and demonstrate knowledge of clinical disease states and treatment guidelines. Effectively communicate product information to healthcare professionals. Analyze trends and develop strategic business plans, leveraging understanding of the market landscape, dynamics, and patient access challenges. Provide solutions to customers by creating a tailored customer experience based on account and HCP needs. Identify opportunities for process improvement, demonstrate willingness to new ideas, and seek innovative approaches to sales and customer engagement. Essential Skills/Experience: Bachelor's Degree 3+ yrs of demonstrated Sales or Commercial experience or a combination of: pharmaceutical, healthcare, scientific, clinical, institutional, or related industry / settings within the healthcare ecosystem Experience in account planning and/or complex reimbursement model OR internal AZ certification A valid driver's license and safe driving record Essential Skills and Capabilities: Advanced Therapeutic Area Expertise: Experience and expertise in highly specialized therapeutic areas Customer Engagement: Proven ability to engage with senior-level healthcare professionals, including specialists and hospital administrators. Innovative Sales Strategies: Experience in developing and implementing innovative sales strategies in a highly specialized market. Clinical Acumen: Exceptional ability to understand and communicate cutting-edge scientific research and clinical data. Strategic Partnerships: Experience in establishing and nurturing strategic partnerships with healthcare institutions and research organizations. Business Acumen: Proficiency in advanced data analysis and the use of analytics to drive sales performance. At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically-led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our agile and entrepreneurial team of visionaries is trusted to innovate and experiment, supported to learn fast from failures and move on. Join us in making a difference - apply today! Date Posted 07-Feb-2025 Closing Date 06-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
    $127k-208k yearly est. 9d ago
  • Medical Science Liaison - Gastroenterology Alliance - Mid-Atlantic region (NC, SC, DE, MD, DC, VA)

    Sanofi Group 4.3company rating

    Alexandria, VA Job

    **Job title** : Medical Science Liaison - Gastroenterology Alliance - Mid-Atlantic region (NC, SC, DE, MD, DC, VA) **About the Job** The **Medical Science Liaison** (MSL) is field-facing role whose main objectives are to: + Be the trusted scientific partner to key external experts by conducting timely, appropriate and frequent scientific exchanges to enhance the understanding of the scientific and medical value of our products. + Execute on stakeholder engagement plans to gather data, develop and share medical insights that contribute to enhancement of Sanofi's key medical messages, plans and future research. + Keep abreast of medical and scientific developments in the therapeutic field to help identify and critically assess research opportunities and to play a supportive role in the execution of evidence generation plans to enhance the value of our products in a real-world setting + Recognize, record and share insights that deepen our understanding of the needs of patients, consumers, regulators, payers, and healthcare providers and proactively contributes towards identifying unmet needs. + Maintain effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory requirements + Demonstrate operational understanding and risk management by ensuring excellence in execution of all governance processes. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **Main Responsibilities:** **Engages external stakeholders on medical and scientific information exchange for the therapeutic area during an one-on-one interactions and group settings, exhibiting excellent scientific and clinical knowledge** + Uses strong knowledge of relevant diseases and disease management protocols, healthcare environment and competitors to articulate the medical and scientific value of our products with external experts. + Establishes robust, long-term peer relationships with Key Opinion Leaders and other stakeholder partners + Actively engages with appropriate stakeholders on medical, clinical, epidemiologic, and scientific topics to advance their understanding of the disease by sharing information and answering questions based on approved material within Regulatory guidelines. + Engages with appropriate stakeholders to understand the state of healthcare policies and guidelines as they relate to clinical practices at a local, state, regional, federal, or national level. + Uses defined systems to maps, identify, profile, and prioritizes stakeholders in line with the therapeutic area medical plan and looks for opportunities to collaborate and build a value based partnership addressing the HCPs therapeutic goals. + Effectively utilizes the Scientific Engagement Model to plan territory and individual stakeholder (Key Opinion Leaders, payers, HCP etc.) medical strategy and engagement interaction plans consistent with the Field Base Medical Activity Plan and medical function priorities. + Effectively utilizes the Scientific Engagement Model for attending and establishing a Sanofi Medical presence at relevant scientific congresses, symposia as directed. + Organizes educational meetings or local scientific advisory boards when requested. + Support speakers training to ensure continued scientific support in the field. + Responds to unsolicited request for medical information associated with supported products and disease state area. **Gathers data and generates insights from stakeholder interactions and provides feedback to the organization** + Recognize and collect feedback/reactions from multiple data sources and various stakeholders. + Record/report insights and information appropriately, using available mechanisms and tools. + Critically and routinely evaluate and discern from the information gained from published studies, and stakeholder interactions to develop key insights that deepen our understanding of the market's needs and opinions of external stakeholders and therefore contribute to enhancement of Sanofi's scientific messages, plans, strategy, systems, and product development. + Maintain awareness of and assesses emerging evidence in disease area to educate and enhance discussions with key stakeholders. **Collaborates effectively with internal stakeholders** + Distribute relevant scientific and medical information and key external insights to internal stakeholders when requested. + Collaborate, as directed, with Commercial Operations, Business Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs. + Contribute to the creation of material for internal and external stakeholders where applicable, following internal Sanofi policies, and Federal and National Policies as applicable. **Supports evidence-generation activities by aiding in data acquisition and identifying opportunities for further data collection clinical or investigator-led** + Monitors disease epidemiology and provides support, including protocol development, when needed on various types of studies: long-term surveillance, compliance, pharmacovigilance, and effectiveness studies + Identifies data collection opportunities during stakeholder interactions and reports these using approved processes. + Maintains awareness of clinical trial activity within territory and suggests clinical trials sites as requested. + Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supports ISS submissions through appropriate internal processes **Context of the job/major challenges** + Able to operate independently (with minimal supervision) and navigate complex regulatory environments in person and via digital channels from remote (non-office based) environment. + Possible substantial travel: nationally and internationally. + Effectively mediate KOL's complex and controversial opinions vs; corporate policy decisions ensuring KOL relationships/medical strategy are not negatively impacted. + Ensures regulatory boundaries re non-promotional activities are respected vis-à-vis commercial partners. **Scope of Role / Outputs** + Manage a base of 50 stakeholders; developing and maintaining stakeholder engagement tracking database. + The territory covers: Washington, DC, Virgina, Maryland, Delaware, North Carolina and South Carolina + Plan day-to-day interactions, including discussion points in accordance with Medical Affairs strategy, establishing a frequency of interactions per stakeholder per year to ensure that objectives are met. + Accountability for US KOLs with reporting mainly to Medical Affairs + Executes on defined KOL territory strategy that is targeted to address diverse stakeholder needs (payers, patients, KOLs, HCP etc.) and is aligned with company objectives. + Develops relevant territory engagement plans in line with the medical strategy and supports the team's medical plan execution. + Uses approved scientific data during KOL interactions to advance the understanding of the therapeutic area. **About You** **Qualifications** + Advanced degree in a technical, scientific or medical field (MD, PhD, Pharm D,) preferred, or other Relevant Life Science degree (RN/MS) with Gastroenterology Specialty required. + Valid driver's license with a clean driving record and ability to pass a complete background check. + Driving a company car in a safe manner to daily meetings and appointments is required. + Responsible for operating the motor vehicle using safe driving practices, knowledge of and compliance with all company policies, and obeying all traffic laws. **Experience** + Previous pharmaceutical industry and/or MSL experience required. + Candidates with relevant Immunology clinical experience consisting of Gastroenterology clinical environment may be considered. + Clear understanding of medical practice, clinical decision making, and healthcare systems related to patient care. + Ability to interpret key scientific data and translate this information to meet educational and research needs. + Demonstrated ability to address educational and research needs through delivery of cutting edge scientific/evidenced based data. + Understand the design and execution of research studies. + Exemplary communication and presentation skills. + Experience in working on multi-disciplinary teams and managing significant volume of projects. + Candidates with relevant Immunology clinical experience consisting of Gastroenterology clinical environment may be considered. **Skills/Knowledge** + Actively listens to others and is adept at confidently stating expert opinion while respecting the positions of others - can exert diplomacy while standing firm on a position. + Utilizes effective, professional communications to cultivate strong working relationships with internal and external colleagues, flexible in own approach to people and situations. + Skillfully plans, prioritizes, and executes multiple responsibilities and projects. + Demonstrates effective leadership skills (by example and through accomplishments), steps forward to handle challenges within scope of authority. + Deep understanding and knowledge of local regulations and codes of practice for pharmaceutical industry, in particular as they apply to the non-promotional activities of this role **.** + Demonstrates scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights. + Knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends. + Proficiency in digital tools. **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. The salary range for this position is $144,750.00 - $193,000.00 USD Annually. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, ******************************** Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Remote \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
    $144.8k-193k yearly 11d ago
  • Director, Biostatistics-RWE

    Daiichi Sankyo 4.8company rating

    Remote Job

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. Responsibilities: Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project. Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product. Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted. Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD). Drug Development Strategy: Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted. Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4. CRO / Vendor Oversight: Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high quality deliverables. Global Health Authority Interaction / Negotiation: Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed. Global BDO Strategy to Improve Drug Development: Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): Master's Degree in statistics or biostatistics required PhD in statistics or biostatistics preferred Experience Qualifications: 10+ Years of relevant experience in the pharmaceutical industry with a masters degree required. 7+ Years of relevant experience in the pharmaceutical industry with a PhD preferred Travel. Ability to travel up to 20% International travel required. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
    $79k-149k yearly est. 5d ago
  • Continuous Improvement Lead

    Sanofi 4.3company rating

    Remote or Bogota, NJ Job

    Job title: Continuous Improvement Lead About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Continuous Improvement Lead within our Business Operations team, you'll provide Continuous Improvement leadership to help standardize and transform our end-to-end process. The role is focused on complex initiatives, that can span transversally across end-to-end process areas and regions, in an environment with a high degree of interdependancy. Main responsibilities: * Provide Continuous Improvement (CI) guidance to Business Operations department. * Maintain and promote the CI framework. * Contribute to Business Operations CI Program, especially during assessment, design and execution phases. * Provide consultancy, mentoring, coaching to CI initiatives. * Lead some CI initiatives, especially the transversal ones. Develop and provide supporting tools and methodology. * Disseminate CI culture across Business Operations department * Design and execute CI training programs * Contribute to CI governance with various stakeholders * Provide the right factual data to Process Owners so they can take the best decisions. * Identify and promote synergies across the different end-to-end process. * Liaise with other PE&I teams (e.g. Process Intelligence, Process Mining, Data, Automation, etc.) to reach the maximum of efficiencies. About you * Experience: * 3-5 years experience in GBS / BPO Shared Services industry or consulting industry. * Certification in CI methodology (Black Belt certified or any other equivalent ). * Knowledgeable in business process in scope (e.g. Finance, HR, Procurement, Manufacturing & Supply, R&D) * Proven track record of impactful contributions to CI programs with tangible results * Soft skills: * Excellent stakeholder management skills, including with Senior stakeholders * Excellent written and oral communication & inter-personal skills, ability to develop high-quality documents * Ability to lead and motivate team members with indirect reporting relationships across multiple geographies. through a CI journey. * Entrepreneurial mindset, and ability to work independently and take initiative under pressure. * Strong collaboration mindset with ability to work with a group of people with different functional expertise. * Adaptability to deliver in ambiguous context, flexible, comfortable with changes. * Efficient analytical skills, attention to details. * Technical skills: Knowledge/certification on Continuous Improvement methodology (Lean Black Belt). * Education: Bachelor's degree (or equivalent) in Business Administration or Science * Languages: Fluent in English is mandatory. Other language is a plus. Why choose us? * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions. * You'll be part of a truly diverse cross-cultural team and can have real business impact. * Flexible working policies, including up to 50% remote work. * Private medical care, life and health insurance, and gender-neutral paid parental leave * Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation. * Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants. Pursue Progress. Discover Extraordinary. Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-LAT #LI-HYBRID Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
    $90k-124k yearly est. 2d ago
  • Director, Global Quality Assurance, GMP Compliance

    Daiichi Sankyo 4.8company rating

    Remote Job

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This is a global role that is responsible for quality compliance of drug substance, drug product and packaging manufacturing sites of DS products. These sites include both DS owned and contract manufacturing organizations (CMOs). Provides QA leadership to support the preparation, execution, and remediation of regulatory inspections of the sites, implements and manages quality compliance programs, and leads mentoring and training activities. The incumbent leads a productive working relationship with internal/external stakeholders such as, but not limited to, contract manufacturing, testing, and/or warehousing organizations, DS affiliates and DS Headquarters in order to ensure the quality of drug products marketed globally and acts as a global partner to successful drive QA GMP organization deliverables as appropriate. This position has a global responsibility to effectively drive the level of accountability and performance needed to achieve the full potential of the organization to deliver biological products to patients with unmet medical needs and to meet Daiichi Sankyo's vision to become a global pharma innovator with competitive advantage in Oncology. Responsibilities Inspection Readiness: Responsible for leading inspection readiness activities, including the execution of mock inspections, on-site inspection support during regulatory inspections, and assistance in any remediation and response activities resulting from regulatory inspections. Executes comprehensive evaluations of GMP readiness status of the global supply chain of internal and external GMP manufacturing organizations, identifying and mitigating risks. Ensures a satisfactory regulatory compliance level for DS internal and external organizations for local and global markets. Liaises with regulatory agencies as needed and internally on GMP QA issues. Leads Global GMP Compliance team's participation in local, regional, and global project teams. Provides direction and consultation services for global project teams. Responsible to contribute to the achievement of global QA vision and enhancing globalization at DS QA-GMP affiliates. Proactively supports Global QA CMO Management and Global QA Audit Program teams. Responsible to ensure that quality improvement initiatives at DS and Global External Suppliers are driven to completion through direction and collaboration with Global External Supplier QA teams. Collaborate with Global Quality Management System (QMS) teams on regulatory-related CAPAs that impact remediation or other projects as assigned. Collaborate frequently with Supply Chain, Pharmaceutical Technology, Regulatory colleagues and Global Quality Systems groups to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and its GMP vendors. Supports Supply Chain and Pharmaceutical Technology functions in the vendor selection process to assure that all newly selected vendors are operating in compliance with the applicable quality program and regulations/ guidelines and are prepared for Regulatory inspections. Collaborate with Global RD/ PV QA teams for any cross-functional regulatory inspections impacting GMP activities and serve as a point person for GMP-relevant matters. Maintain up-to-date knowledge of current Good Manufacturing Practice (cGMP) regulations. Train and mentor staff on global GMP regulations and guidance. Develop and motivate staff to develop a mature GMP and Quality Culture. Hold self-accountable to achieve the level of integrity, ethics necessary to drive sustainable results and performance, including development and maintenance of a culture driven by values of integrity, respect, and speak-up principles. Create an environment that thrives on innovation, and proactive quality and is disciplined to efficiently execute against pre-defined deliverables. Drive employee engagement, mentoring, coaching and performance management. Communicate clearly and in a timely manner with supervisor, the Global QA organization and local leaders of DS QA-GMP affiliates to address and identify a proactive solution for business contribution, and the ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of the Global QA mission across boundaries and with different stakeholders. Continuously review compliance metrics trends from regulators/ industry experts and advise the GMP road map to meet changing regulatory and business needs. Lead remediation and risk management to assure the organization's Quality Management System is robust and ensure knowledge transfer and continuous process improvement in collaboration with other QA functions. Drive effective relationship with alliance partners, collaborators, CMOs, and other key company partners to ensure a culture of compliance at all levels. Create and maintain project management methodologies. Support the global GMP quality annual objectives, strategic initiatives to deliver against the business plan. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree required Master's Degree preferred Experience Qualifications 5 or more years direct Health Authority experience desired 10 or more years professional experience at a management level, leading a QA organization or regulatory authority and demonstrated track record of successful results required. 7 or more years of professional experience managing many aspects of quality in an international, global context in a regulated healthcare environment required. Must have experience working with biologics. Proven expertise in risk management, continuous improvement, change management, and evolving the capabilities of an organization required. Demonstrated experience working directly with global Health Authorities (FDA, EMA, MHRA, etc.) and other government and local agencies required. Must have strong working knowledge of the end-to-end manufacturing process and laboratory operations required. Must have solid understanding of quality management and continuous process improvement principles including global cGMP and GLP requirements required. Physical Requirements standing and walking for long periods of time, ability to climb stairs, and perform gowning in laboratory and manufacturing sites. Travel Must have ability to travel up to 50% including overnight and international travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
    $129k-187k yearly est. 5d ago
  • Plasma Center Supervisor

    Takeda 4.7company rating

    Takeda Job In Harrisonburg, VA

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. You will report to the Center Manager and oversee the general management of employees assigned to the production areas. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. How you will contribute: You will oversee employee performance and scheduling You will lead Inventory Control efforts and lead in operational efforts You will work with donors to resolve concerns You will analyze opportunities specific to non-conforming events You will perform all tasks for Medical History, Phlebotomy, and Sample Processing areas. You will foster teamwork, communicate and resolve conflicts. What you bring to Takeda: High school diploma or equivalent Cardiopulmonary Resuscitation (CPR) and AED certification Frequent bending and reaching Ability to walk and stand for entire shift, frequent lifting to 32 pounds and occasional lifting to 50 pounds Fine motor coordination, depth perception, and ability to monitor equipment from a distance Because of potential exposure to bloodborne pathogens, pro-longed glove wear is required What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - VA - Harrisonburg U.S. Hourly Wage Range: $21.92 - $30.14 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - VA - HarrisonburgWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No
    $21.9-30.1 hourly 3d ago
  • Associate Specialist (First Shift 6 AM - 3 PM)

    Astrazeneca 4.6company rating

    Gaithersburg, MD Job

    Associate Specialist (First shift, 6am-3pm) Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. We're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. Working here also means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. About AstraZeneca in Gaithersburg, MD: Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most groundbreaking technology and lab spaces, all designed to inspire collaboration and multi-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration. The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center. This is where you'll find newly designed, activity-based workspaces to suit many different working styles while increasing collaboration between teams. Summary of the Role: As an Associate Specialist in the clinical production team within Biopharmaceutical Development, you'll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role, you will take an adaptable, science driven approach to everything you do. You will become an integral part of process development, accelerating product candidates into the clinic, and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skills to perform large scale clinical development activities through hands-on training. You will join a collaborative and driven team in a world class biopharmaceutical company that is driving radical innovation in the industry. Main Duties & Responsibilities: • Operates bio-pharmaceutical manufacturing equipment such as: incubators, stainless steel and disposable bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks, and in-process testing instruments. • Performs steam sterilization, clean in place, manual cleaning, and sanitization of equipment. • Records manufacturing activities clearly and accurately within approved current good manufacturing practices (cGMP) documents and regulatory requirements. • Prepares for processing by ensuring equipment and materials necessary are adequate and available. • Ensures a safe and environmentally sustainable work environment in accordance with AstraZeneca standards • Ability to use MS Office tools and AstraZeneca enterprise systems Education & Experience Requirements: Bachelor's degree and 0+ years of relevant experience is required Required Skills: • Dynamic individual with the ability to communicate and engage others. • Demonstrate a high level of drive and initiative. • Familiarity with area specific production equipment such as parts washers, autoclaves, fixed and portable stainless-steel tanks, etc. • Familiarity with basic chemistry concepts. • Introductory knowledge of raw material weigh-out and media/buffer preparation. • Ability to work with others in a team environment Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our journey. So, what's next? Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours. Where can I find out more? Our Social Media: Follow AstraZeneca on LinkedIn ************************************** Follow AstraZeneca on Facebook ******************************************** Follow AstraZeneca on Instagram **************************************************** The annual base pay (or hourly rate of compensation) for this position ranges from 60,583.20 - 90,874.80 USD Annual . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an 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 pay (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. Date Posted 03-Feb-2025 Closing Date 27-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
    $76k-98k yearly est. 10d ago
  • Part Time Entry Level Phlebotomist - Chesapeake, VA

    Takeda 4.7company rating

    Takeda Job In Chesapeake, VA

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. Phlebotomist About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will greet donors as they enter and exit the donor floor. · You will perform venipuncture of donors and programming of plasmapheresis machine. · You will monitor donors during the donation process and manage donor reactions. · You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training. · You will install, prime, and disconnect disposable sets on the plasmapheresis machines · You will stock supplies, break down empty cartons and assist with proper disposal. · You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system. · You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight. · You will enter donor information into the Donor Information System (DIS). · You will coordinate donors to donor floor and compensate donors using the Debit Card system. · You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - VA - Chesapeake U.S. Starting Hourly Wage: $17.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - VA - ChesapeakeWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $17 hourly 14d ago
  • Senior Statistician - Cardiovascular, Renal & Metabolism (CVRM)

    Astrazeneca 4.6company rating

    Gaithersburg, MD Job

    Job Title: Senior Statistician - Cardiovascular, Renal & Metabolism (CVRM) At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Introduction to Role: Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you. Those who join AstraZeneca not only feel a sense of ownership about their future, but also know that their work has a huge impact on patients. With AstraZeneca, you will be applying innovative and creative approaches to science while being at the forefront of a strong and rich pipeline of cutting-edge medicines. Here, you will join passionate professionals who push the boundary of science and technology to develop and deliver life-changing medicines designed to help people live better lives. Our CVRM pipeline includes investigational therapies in varied stages of clinical development, from recently approved products to earlier-stage molecules in clinical trials. We aspire to transform the lives of patients, working not only to prolong patients' lives, but to also improve their function and help patients feel better. We are currently recruiting for statisticians at Senior level depending on your previous experience to join our team supporting the CVRM portfolio. We are growing at this site and have multiple positions available. A successful candidate has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a clinical study. This individual is able to lead and direct Biometrics work either in house or partnering with CROs to ensure delivery to quality and time. Accountabilities: Lead the statistical thinking and contributions to the delivery of clinical studies, regulatory strategy, health technology assessment and/or commercial activities. Contribute to quantifying the benefit, risk, value and uncertainty of the emerging drug product profile. Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation. Lead the delivery and oversight of clinical studies to time, quality and standards, including partnering with CROs and with programming. Collaborate with and influence cross-functional colleagues working on clinical studies. Where applicable, support the project statistician on activities such as study design, power calculations, decision criteria, regulatory interactions and submissions. Contribute to development of new procedures and standards to increase quality, efficiency, and effectiveness. Where applicable, mentoring and coaching junior staff and supporting them with education and training in Statistics. We offer the chance to influence drug development and the opportunity to gain experience across a range of challenging and exciting projects including PhI-IV studies and in the different indications within CVRM. Essential Skills/Experience: MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area. 1-5 years of experience of pharmaceutical development, data analysis and interpretation. Knowledge of the technical and regulatory requirements related to the role. Leadership capabilities to be able to lead and direct clinical study work. Strong knowledge of programming in R and/or SAS. Excellent written and spoken English. Excellent communication skills (including communicating with non-statisticians) and ability to build strong relationships. Excellent collaboration skills required - the energy to work across global & functional boundaries, both internally and externally. Ability to apply statistical expertise to complex problems, problem solving and quality focus. Desirable Skills/Experience: PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area. Total Rewards: The annual base pay for this position ranges from $119,335.20 to $179,002.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an 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 pay (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. AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing *********************************. #LI-Hybrid Date Posted 12-Feb-2025 Closing Date 11-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
    $119.3k-179k yearly Easy Apply 3d ago
  • Director of Translational Regulatory Science

    Astrazeneca 4.6company rating

    Gaithersburg, MD Job

    “US AstraZeneca offices will be closed from December 25th to January 1st, re-opening January 2nd. We encourage you to apply to jobs of interest and we will review applications upon our return.” Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us! At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover. Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. Accountabilities: In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful early and late Oncology development projects on a global scale. You will serve as the translational regulatory lead on early-stage or late-stage projects, and/or specific indications of larger programs. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements in Oncology clinical trials, including those for innovative biomarkers, technologies (e.g., ct DNA, computational pathology, AI/ML), and therapeutics are met throughout the drug development process. Essential Skills/Experience: Masters of Science degree in life sciences or a related field. Minimum of 5 years of experience in regulatory affairs or a closely related field. Expertise in therapeutic product regulations, with a detailed understanding of global regulatory frameworks. Understanding of regulatory affairs in Oncology throughout both early- and late-stage development. Demonstrated proficiencies in strategic thinking, internal and external influencing, innovation, initiative, leadership, and exceptional oral and written communication skills. Strong abilities in communication, negotiation, and problem-solving. Proficiency in working within cross-functional teams and balancing multiple priorities. Excellent organizational and project management abilities, with keen attention to detail. Capacity to work autonomously while maintaining high-quality standards. Desired Experience: Ph.D., or Pharm.D. degree in life sciences or a related field. Experience in Oncology (small molecules & biologics) is preferred. Prior experience with phase 3 design including end of phase 2 health authority interactions. Contribution to a regulatory approval including leading response team and labelling negotiation. Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design. Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Ability to work strategically within innovative, business critical and high-profile development programs. Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component. Technical experience and understanding of biomarker innovations such as use of AL/ML computational pathology, or digital health would be advantageous. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The annual base pay (or hourly rate of compensation) for this position ranges from $154,403 to $239,105. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an 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 pay (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. At AstraZeneca, we're motivated by science, success and achieving our goals in a way that's novel and thoughtful. We see change as an opportunity, embracing the possibility to learn, grow and evolve. Supporting our peers is just as important to us, that's why we keep working together, sharing knowledge and setting each other up to succeed. As an industry-leading Oncology Regulatory function, we drive efficiency and innovation to bring medicines to patients as quickly as possible. We play a key role in making sure our transformative science born in labs will be transformed into real value for patients. We break down barriers between areas, working in partnerships internally and externally. We are striving for technology adoption and automation to drive efficiencies and new innovations. We believe that by asking questions and trying new things, we can drive innovation and develop modern approaches. Are you ready to play your part in gaining approval for our novel work on unmet medical needs? Apply now to join our team at AstraZeneca! Date Posted 19-Dec-2024 Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
    $154.4k-239.1k yearly 10d ago
  • Business Development Consultant, Pets (Remote) (16637)

    Boehringer Ingelheim 4.6company rating

    Remote or Duluth, MN Job

    Compensation Data This position offers a base salary typically between $100,000 and $156,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Business Development Consultant is responsible for generating sales, market share and profitability within high-potential clinics and new clinic leads. The incumbent accomplishes this by expanding Boehringer's sales in low-revenue, high-potential clinics and by prospecting new clinics, turning them into Boehringer customers. This role identifies the best opportunities and clinics within which to gain new business and expands Boehringer's portfolio. The position holder builds strong relationships with all the key clinic stakeholders and completes a development program including Boehringer technical product and sales training. This role develops and leverages tailored solutions to support company revenue growth and profitability. Duties & Responsibilities Clinic Account Development: Implements and executes effective sales strategies to place Boehringer products in high potential and new clinics, growing Boehringer's sales & customer base. Develops an excellent knowledge base of all assigned clinics, including the products they stock, their business objectives, their decision-making processes, the key staff members, and technology footprint. For assigned clinics, builds, and executes a clinic development plan identifying the best strategic path to gain Boehringer product placement. Proactively works with assigned district managers & sales representatives to share clinic development plans. Keeps all business plans up to date on an ongoing basis, sharing its content with appropriate district managers and sales representatives. Provides complete technical product training to clinic staff to ensure clinics understand the benefits and differentiation of Boehringer products compared to the competition. Tracks product placements within a clinic and ensure traction of the products allowing for product expansion. Within each clinic, identifies key clinic team members and builds relationships with the decision-makers and staff, understanding their goals, challenges and needs. Negotiates terms and agreements to drive product placement and maintain clinic share of wallet. Opportunity Management: Analyzes all available data, including but not limited to sales, market share data and competitive intelligence, to identify high potential and low value clinics and new clinic leads. Works in collaboration with district managers & sales representatives to prioritize clinics to pursue and gain product placement through the execution of the clinic development plan. Gains new product placements and win new business within the prioritized clinics by developing and executing a technical product training and sales program that demonstrates the benefits of Boehringer products. Maintains an accurate and documented pipeline of opportunities within the clinic development plan. Routinely discusses and communicates opportunity plan and strategy with appropriate district managers and sales representatives. Continuously gathers knowledge of competitors and how to effectively position Boehringer's solutions against them. Sales and Business Performance Management: Meets sales objectives and supports attainment of district and regional/ business unit performance objectives. Maintains and utilizes Boehringer and competitive product and technical knowledge as well as expertise in Boehringer supported tools. Analyzes customer information and monitors market conditions to optimize customer calls. Utilizes highly effective selling and strategic account management skills to convince customers to stock Boehringer products. Executes brand, portfolio and Boehringer supported tool strategies to ensure a consistent company sales and marketing message. Utilizes CRM tools to create pre-call plans and maintain clinic records concerning activities. Completes objectives including achieving sales plan while operating within specified expense budget. Leads team meetings, communicates, and collaborates regularly with district team members. Requirements BS/BA degree required, MBA, Veterinary, Animal Science or comparative degree preferred. Seven (7) years of relevant sales experience, with a minimum of five (5) years focused on generating new business. Must possess strong leadership and coaching skills to maximize performance results. Must demonstrate an aptitude and desire to sell and gain market share. Knowledge of the Animal Health/Veterinary Clinic Industry economics and drivers preferred. Ability to work and thrive in a matrix team environment. Excellent communication, negotiation, and presentation skills (verbal and written). Excellent interpersonal and communication skills. Ability to lead without authority and inspire a team to follow. Strong learning agility. Demonstrated high level of business and financial acumen. Proficiency in various business software applications. Ability to travel (up to 60% overnight travel domestically). Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental car. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities Additional Duties & Responsibilities: Business Development Specialist Team Leadership: Builds and leads an effective cross functional clinic team for all assigned accounts. Leads and participates in internal business development and district team meetings and communicates with Business Development Consultants and district team members to ensure successful execution of strategy. Provides periodic clinic development plan updates to team members. Proactively seeks to contribute to BIAH's organizational growth objectives by providing mentoring and coaching new members of the accounts team, as well as new BIAH employees. Market and Industry Knowledge: Develops market, customer, and industry knowledge. Monitors market conditions for changes that impact the animal health business. Ensures effective utilization and management of internal and external resources.
    $100k-156k yearly 60d+ ago
  • Medical Customer Service

    Takeda 4.7company rating

    Takeda Job In Salisbury, MD

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MD - Salisbury U.S. Starting Hourly Wage: $17.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MD - SalisburyWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $17 hourly 19d ago
  • Scientist

    Astrazeneca PLC 4.6company rating

    Gaithersburg, MD Job

    The Early Discovery Oncology IHC team at AstraZeneca in Gaithersburg, MD is seeking a highly motivated scientist with a proven track record in histology and immunohistochemistry. The successful candidate will work independently and in collaboration with others to conduct scientific research as part of a team effort. The candidate will be responsible for the development of IHC/ISH methods, tissue sectioning, and other histological techniques, as needed. In this cross-functional role, the selected candidate will participate in project teams and work in a multidisciplinary environment to advance projects. Accountabilities * Assists the team in the development of IHC/ISH assays in support of early target discovery. Communicates results to team members. * Assesses and reports data in a clear and concise manner, while understanding the implications to the overall context of drug discovery. * Will perform microtomy sectioning for the early oncology team. * Ensures own work, and work of peers, is compliant with Good Laboratory Practice, Safety, Health, and Environment standards and all other relevant internal AstraZeneca standards and external regulations. * Assists in the ordering and organization of necessary reagents and supplies for the histology lab. * Will learn how to independently operate autostainers to help team generate data and support the maintenance upkeep of all automated systems. Essential Skills/Experience * Bachelor's Degree in biology, immunology or other relevant biological discipline, with 2-4 years of work experience OR a Master's Degree with 0 years of experience. * Ideal candidate should have a background in research and some exposure to immunohistochemistry and histology techniques. * The position is a hands-on, primarily laboratory-based position. * An organizational skillset is essential to the role. * Responsible for the application of immunohistochemistry principles and techniques to help validate new targets. * Prepares precise technical summaries, protocols and all appropriate documentation of experiments in laboratory notebooks. * Responsible for the correct operation and utilization of lab equipment, and overall state of the shared lab space. * Will be responsible for establishing working relationships and credibility with department members and others within the company. * This position requires excellent oral and written communication skills. * Ability to prioritize and work in a fast-paced, matrixed environment is required. Desirable Skills/Experience * The successful applicant will have a desire to learn basic human tissue histology and identification of basic elements of tissue under the microscope. * Candidate will be familiar with the use and application of Westerns and flow cytometry as they pertain to the validation of commercial antibodies. At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs. We are united in our vision to eliminate cancer as a cause of death, making bold moves that transform treatment and improve patient outcomes. Our collaborative environment draws on diverse knowledge from across the business and external partners, empowering us to take smart risks, challenge norms, and learn from failures. Join us at the forefront of applying science to studies, using innovative approaches to create new possibilities! Ready to make a difference? Apply now! The annual base pay for this position ranges from $87,200.00 - 130,800.00. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an 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 pay (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. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
    $87.2k-130.8k yearly 13d ago
  • Plasma Center Nurse (RN)

    Takeda 4.7company rating

    Takeda Job In Baltimore, MD

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA) Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MD - Baltimore - West U.S. Hourly Wage Range: $34.62 - $47.60 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MD - Baltimore - WestWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No
    $34.6-47.6 hourly 9d ago
  • Medical Screener/Phlebotomist PT and FT

    Takeda 4.7company rating

    Takeda Job In Hampton, VA

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - VA - Hampton U.S. Starting Hourly Wage: $16.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - VA - HamptonWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No
    $16 hourly 12d ago

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Takeda Pharmaceuticals U.S.A., Inc. may also be known as or be related to Takeda, Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals U.S.A. Inc., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceuticals USA Inc.