Work Location: Billerica, Massachusetts Shift: No Department: HC-RD-RPD US Ad/Promo Recruiter: Rena Ann Peterson
This information is for internals only. Please do not share outside of the organization.
Your Role
The Director of Advertising and Promotion, Prescription Drug Products manages and/or participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are in compliance with all applicable laws, regulations, and regulatory agency guidance
Manages or represents Regulatory Affairs on the promotional review committees for prescription products to review promotional materials for compliance with regulatory requirements while meeting the Company's strategic promotional objectives.
Implements regulatory strategies and solutions to assure that US advertising and promotional materials are in compliance with regulatory requirements and Company policies.
Provides guidance and strategic support on proposed claims for products in development and helps develop Important Safety Information (ISI) and Brief Summary documents as appropriate.
Continually develops, assesses and revises advertising and promotion-related processes and SOPs as needed, to enhance efficiencies and compliance.
Regularly monitors the regulatory compliance trends in industry, interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business.
Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.
Develops communication packages for regulatory advice, response to FDA action letters, and leads the company in discussions with OPDP and APLB.
Coordinates company-wide ongoing training on regulatory issues pertaining to product promotion. Other job responsibilities as needed
Who You Are
Minimum Qualifications:
Bachelor's degree in science or health related discipline (Advanced degree [PhD, MD, MS, PharmD highly preferred)
Oncology is strongly preferred
Preferred Qualifications:
Knowledge of regulations related to prescription drug promotion
Working knowledge of Rx NDA, BLA and labeling development and approval process
Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
Strong interpersonal skills with the ability to lead and influence, cross-functional colleagues in a positive and effective manner
Ability to work in a team environment
Excellent communication skills, both oral and written
Seven to 10 years of relevant pharmaceutical industry experience with 5 years of relevant Regulatory Affairs prescription product advertising and promotion review experience. Experience with oncology drug promotion and product launches preferred.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
