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You will be updated with latest job alerts via email$ 135100 - 225100
1 Vacancy
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 teams 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 APLBissues 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.
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 providers 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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Required Experience:
Senior Manager
Full-Time