Manager, US Regulatory Advertising and Promotion
About The Position
Role Summary The Manager, US Regulatory Advertising and Promotion (US RAP) provides regulatory guidance and strategic support for the review of promotional communications, ensuring regulatory requirements and business needs are met in a manner compliant with regulatory standards and Pfizer internal policies. The Manager may interact with the Office of Prescription Drug Promotion (OPDP) or the Advertising and Promotional Labeling Branch (APLB) on routine matters, under the direction of more senior personnel. The Manager may mentor or provide guidance to more junior personnel within the group. Role Responsibilities Operate in collaboration with the lead US RAP Reviewer(s) to develop the skills necessary to become a fully independent reviewer and subject matter expert. With management oversight, review and advise on promotional communications ensuring they are: accurate, truthful and not misleading, presented in a fair and balanced manner consistent with applicable product labeling well-substantiated by current and scientifically valid evidence adherent to applicable advertising and promotion standards comply with all internal and external policies and procedures With management oversight, review and advise on non-promotional corporate/medical/scientific communications for compliance with regulations, guidance documents, and internal policies/best practices Identify potential regulatory risks and propose strategies to address/mitigate Represent US RAP perspective in cross-functional review team meetings Interact with OPDP/APLB staff on administrative and logistical issues for assigned products Contribute to development of functional area and cross-functional written procedures Monitor and update internal stakeholders on regulations, guidance, regulatory actions, and the competitive landscape Support execution of regulatory strategy Mentor or provide guidance to more junior individuals, as needed
Requirements
- BA/BS
- 4+ years relevant experience (allowances for experience may be made for advanced degrees)
Nice To Haves
- Life sciences degree
- Advanced degree in a relevant field (science, pharmacy, law)
- RAP experience
Responsibilities
- Operate in collaboration with the lead US RAP Reviewer(s) to develop the skills necessary to become a fully independent reviewer and subject matter expert.
- With management oversight, review and advise on promotional communications ensuring they are: accurate, truthful and not misleading, presented in a fair and balanced manner consistent with applicable product labeling well-substantiated by current and scientifically valid evidence adherent to applicable advertising and promotion standards comply with all internal and external policies and procedures
- With management oversight, review and advise on non-promotional corporate/medical/scientific communications for compliance with regulations, guidance documents, and internal policies/best practices
- Identify potential regulatory risks and propose strategies to address/mitigate
- Represent US RAP perspective in cross-functional review team meetings
- Interact with OPDP/APLB staff on administrative and logistical issues for assigned products
- Contribute to development of functional area and cross-functional written procedures
- Monitor and update internal stakeholders on regulations, guidance, regulatory actions, and the competitive landscape
- Support execution of regulatory strategy
- Mentor or provide guidance to more junior individuals, as needed
Benefits
- participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program
- 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
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
