Description
**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
**Qualifications**
**BASIC QUALIFICATIONS**
+ BA/BS
+ 4+ years relevant experience (allowances for experience may be made for advanced degrees)
**PREFERRED QUALIFICATIONS**
+ Life sciences degree
+ Advanced degree in a relevant field (science, pharmacy, law)
+ RAP experience
**PHYSICAL/MENTAL REQUIREMENTS**
n/a
**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
Occasional US travel may be required (< 5%)
Work Location Assignment: Hybrid
**This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed.**
The annual base salary for this position ranges from $93,600.00 to $156,000.00.* In addition, this position is eligible for 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. 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. * The annual base salary for this position in Tampa, FL ranges from $84,400.00 to $140,600.00.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
**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 disabilityrecruitment@pfizer.com. 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.
Regulatory Affairs
