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The 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. 

ROLE RESPONSIBILITIES

• 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.
• Monitor and share with RC Members information on regulatory developments. Effectively communicate regulatory issues and concerns to senior governance group including Marketing, Legal and Medical.
• Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies.
• Assist with the development of policy and internal guidance.
• Ensure business compliance and implementation of and adherence to Regulatory standards.
• Regulatory review of internal and external business communications.
• Engage with Agency contacts in OPDP and APLB in order to improve Regulatory environment.
• Enhance collaboration across a matrixed organization while developing and maintaining constructive relationships.

QUALIFICATIONS

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

BASIC QUALIFICATIONS

• BS or equivalent is required.  Prior Experience Required.
• Five to seven years of pharmaceutical experience including significant US Advertising & Promotion expertise. Regulatory Ad Promo experience required.
• Demonstrable experience of effective delivery in complex matrix environment.
• Strong negotiation and communication skills.
• Level of the selected candidate will be determined based upon multiple factors including relevant education, overall experience, and prior track record.

PREFERRED QUALIFICATIONS

• Science degree/advanced degree is preferred. 
• Experience interacting with FDA including OPDP and APLB preferred.

Other Job Details:

• Last Date to Apply for Job: March 1, 2021
• Additional locations- Collegeville, PA
• Eligible for Employee Referral Bonus: YES