Description
**ROLE SUMMARY**
The Senior Manager, US Regulatory Advertising and Promotion will provide strategic support to the review of Advertising and Promotion materials in order to meet the US brand team’s objectives while ensuring the necessary level of regulatory compliance including meeting Office of Prescription Drug Promotion (OPDP), Advertising Promotional Labeling Branch (APLB) standards and Pfizer internal policies.
**ROLE RESPONSIBILITIES**
+ Ensure that reviewed promotional materials 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, and comply with all internal and external policies and procedures
+ Work independently and recognize when issues need to be elevated to Senior Management
+ Monitor and share with RC Members information on material regulatory developments and trends relevant to the RC generally, OPDP and APLB issues and a given promotional material
+ Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies
+ Effectively communicate regulatory issues and concerns to senior governance group including Marketing, Legal and Medical.
+ Ensure business compliance and implementation of and adherence to Regulatory standards
+ Regulatory review of any internal and external business communications
+ Engage in appropriate activities in order to improve the regulatory environment through Agency contacts: OPDP, APLB and trade associations as appropriate.
**BASIC QUALIFICATIONS**
+ BS/BA or equivalent. Science degree/advanced degree is preferred.
+ 6+ years industry/applicable experience. Allowances for experience may be made based on multiple factors, including relevant education, advanced degrees, fellowships, and overall experience.
**PREFERRED QUALIFICATIONS**
+ Life sciences degree
+ Advanced degree in a relevant field (science, pharmacy, law)
+ Advertising & Promotion experience
+ 1+ years in relevant disease area(s)
+ Experience interacting with FDA including OPDP and APLB
**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
Occasional travel may be required.
Work Location Assignment: **This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.**
The annual base salary for this position ranges from $135,100.00 to $225,100.00. 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 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
