Director US Advertising Promotion Pfizer Collegeville

Job Description: • 2-minute read •
Director, 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.

Ensure that reviewed promotional Materials are (i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures, including Global REG08.
Provide support for potential new product launches; promotional review of launch materials, implementation of OPDP and APLB advisory comment submissions and interactions with the Agency.
Work independently and recognize when issues need to be elevated to Senior Management.
Lead the development of and updates to the Approved Claims List.
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.
Assist with the development of policy and internal guidance.
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.
Mentor newer staff members across the varied disciplines across multiple review committees.
REQUIREMENTS

BS or equivalent is required. Science degree/advanced degree is preferred.

Prior Experience:

Six years or greater Pharmaceutical experience including significant Advertising & Promotion expertise. Regulatory Ad Promo and launch experience a plus.
Demonstrable experience of effective delivery in complex matrix environment.
Strong negotiation and communication skills.
Experience interacting with FDA including OPDP and APLB preferred.

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