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  • Global IVD Regulatory Center of Excellence…

    Pfizer (New York, NY)



    Apply Now

    Why Patients Need You

     

    At Pfizer, our mission is to deliver breakthroughs that change patients' lives. As the Global IVD Regulatory COE Portfolio Manager, you will play a critical role in advancing oncology regulatory strategy programs, supporting the development and delivery of innovative medicines and diagnostics.

    What You Will Achieve

    You will oversee and manage initiatives within the IVD Regulatory Center of Excellence (COE), supporting oncology regulatory strategy programs across the drug development lifecycle. You'll collaborate with cross-functional teams and external partners to drive high-quality IVD co-development program timelines, dashboards, and tools, enabling accurate reporting and decision-making. Your expertise will help resolve project issues, guide operational teams, and facilitate agreements across the enterprise.

    How You Will Contribute

    + Oversee a global portfolio of IVD regulatory projects, ensuring timely initiation and execution of cross-functional study start-up activities.

    + Plan and schedule project timelines and milestones using appropriate tools prior to study start-up.

    + Forecast and plan resource requirements (people, financial, technology) for projects across the IVD Regulatory COE/Portfolio.

    + Lead and support cross-functional issue resolution and mitigation activities, both internally and externally.

    + Coordinate and lead discussions between Oncology Regulatory Strategy and CTRSE Regulatory PM (GSPM) to ensure alignment of decisions.

    + Manage and participate in pre-studies, projects, and other activities to increase operational efficiencies and support business imperatives.

    + Facilitate dissemination of educational and training materials to advance new concepts and methodologies.

    Qualifications** **Must-Have:

    + Bachelor's degree required; Master's degree preferred.

    + Direct experience leading projects in a highly regulated environment.

    + Proven ability to manage multiple projects with competing deadlines.

    + Knowledge of IVD manufacturing and associated processes.

    + Excellent oral and written communication skills.

    + Proficiency with Microsoft applications.

    Nice-to-Have:

    + Experience managing pharmaceutical, technical, IVD, or medical device projects and/or clinical programs.

    + Experience leading regulatory submissions for IVD and/or drug applications.

    + Experience with Microsoft Project or equivalent systems.

    + Certification in operational excellence methodologies (e.g., Six Sigma, Lean).

     

    Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Relocation support available

     

    Work Location Assignment: Hybrid

     

    The annual base salary for this position ranges from $120,800.00 to $201,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

     

    Relocation assistance may be available based on business needs and/or eligibility.

     

    Sunshine Act

     

    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

     

    EEO & Employment Eligibility

     

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

     

    Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

     

    Medical

     


    Apply Now



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