Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. We value every employee and throughout their career encourage them to grow, develop and express their views freely.
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.
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.
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.
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.
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
Internal Number: 4803847
About Pfizer Inc.
Pfizer Global Research and Development (PGRD), Pfizer’s discovery and development division, is one of the finest pharmaceutical research institutions in the world. Our focus is clear - to discover and deliver an ever-increasing variety of medicines to significantly enhance the health and quality of life for people and animals around the world. We accomplish this with multidisciplinary teams of scientists and technology professionals who perform exemplary science, innovation and extraordinary teamwork.
Pfizer’s success is evident in our industry-leading pipeline of drugs. Our search for new treatments spans hundreds of research projects across 31 major disease groups and therapeutic areas - more than any other company on the globe. Included are oncology, anti-infective and anti-virals, central nervous system, cardiovascular, diabetes, obesity, and ophthalmology. Pfizer is responsible for many recognized drug breakthroughs that rank first in sales in their class, including several with which you may be familiar -- Lipitor (for high cholesterol), Zithromax (an oral antibiotic), Norvasc (for hypertension), and Viagra (for erectile dysfunction).