Independently author, edit, and revise technical and regulatory documents for submission to the FDA and other agencies with deep scientific understanding of scientific, technical, and experimental methods, results, and workflows. In collaboration with the Research Project Management function, will ensure each SRS team member develops project specific IND tracking tools for the project teams to facilitate the IND submission operational process. Ensure direct report(s) in your group timely complet... more details
WHY PATIENTS NEED YOU
Pfizer Oncology Research Unit colleagues play a key role in not only discovering new therapeutics but also in connecting our innovations including non-clinical scientific data and evidence with the Pfizer Oncology Development colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
POSITION SUMMARY
Reporting to the Head of Portfolio Strategy and Scientific Operations, you will be responsible for all Oncology regulatory submissions (e.g., IND, CTA, BLA, NDA, PIP, Annual Reports, IB updates) with significant impact on the business by providing strategic, scientific, and operational partnerships to the Research functions under our Oncology Research Unit (ORU).
Within our ORU, you will work closely with Research Project Leaders (RPL), Research Project Managers (RPM) and engage with cross-functional teams to gain proficiency in the science behind the Pfizer pipeline to produce high-impact scientific communication materials.
You and your team will partner with Research Project Leaders and the Research Project Teams to develop IND strategy for the non-clinical pharmacology sections during Lead Development stage preparing for IND submission post Candidate Selection (CS).
You and your team will author the nonclinical pharmacology modules of all regulatory submission documents.
KEY RESPONSIBILITIES
Independently author, edit, and revise technical and regulatory documents for submission to the FDA and other agencies with deep scientific understanding of scientific, technical, and experimental methods, results, and workflows.
In collaboration with the Research Project Management function, will ensure each SRS team member develops project specific IND tracking tools for the project teams to facilitate the IND submission operational process.
Ensure direct report(s) in your group timely complete regulatory submission documents at the expected quality level.
Proactively anticipate problems and streamline workflows and process to avoid or minimize business impact with any regulatory submission delays.
Serve as a member of decision-making bodies and be responsible for setting the long-range plans for their overall responsibilities together with the department executive.
Regularly interact with senior management within and outside research to structure processes, timelines and work appropriately for team members and deliverables.
Manage across all levels in the organization and when necessary, interface with governing committees outside of their function.
Manage priorities and team that author and revise regulatory documents for submission to the FDA and other agencies, including the development of abstracts and presentations for medical congresses or scientific meetings and manuscripts for publication in peer-reviewed journals.
MINIMUM REQUIREMENTS
Bachelor's Degree and 15+ years of regulatory submission experience in the biopharmaceutical industry OR
Master’s degree (MA/MS/MBA) and 13+ years of experience in the biopharmaceutical industry OR
PhD/PharmD and 10+ years of regulatory submission experience in the biopharma industry.
5+ years of people management experience, including experience including leading team members on challenging tasks and complex issues.
In-depth knowledge of the drug discovery activities especially research and development experience for small molecules and biologics.
Strong written and oral communication skills.
PREFERRED REQUIREMENTS
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: On Premise
The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.
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