Director, US Regulatory Advertising and Promotion Details

Director, US Regulatory Advertising and Promotion

Pfizer - New York, NY

Employment Type : Full-Time

ROLE SUMMARY

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.

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.

• BS or equivalent is required. Science degree/advanced degree is preferred. Prior Experience Required.
• Five to seven years 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.
• Experience interacting with FDA including OPDP and APLB perfered.
• Level of the selected candidate will be determined based upon multiple factors including relevant education, overall experience, and prior track record.

Other Job Details:

• Last Date to Apply for Job: February 4, 2021
• Additional sites - Collegeville, PA
• Eligible for Employee Referral Bonus: YES

#LI-PFE

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.