Sr. Manager, Regulatory Affairs, Advertising and Promotion

Alnylam Pharmaceuticals

  • Cambridge, MA
  • Permanent
  • Full-time
  • 1 month ago
Sr. Manager, Regulatory Affairs, Advertising & Promotion

Overview

Alnylam is the world’s leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with two approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,400 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine’s #1 Top Employer in 2019. Please visit for more information.

The Senior Manager for U.S. Advertising and Promotion (AP) will provide regulatory review of communications about Alnylam’s marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and other audiences, with the objective of ensuring they comply with U.S. laws and regulations and Alnylam policies, while supporting achievement of business objectives. This position will report to a Director of U.S. Advertising and Promotion in Regulatory Affairs.

Summary of Key Responsibilities
  • Serve as Regulatory Reviewer on Commercial and Medical Review Boards for assigned product(s), and as Regulatory AP representative on program and other cross-functional teams
  • Collaborate with colleagues in Commercial, Legal, Medical Affairs and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s)
  • Consult with supervisor and colleagues in risk assessment of new claims and/or tactics, and communicate regulatory position and risk mitigation strategies
  • May prepare correspondence for or interact with the Office of Prescription Drug Promotion (OPDP) at FDA
  • Recommend efficiencies and improvements in Review Board practices Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA
  • Provide Regulatory Strategy and Global Labeling colleagues with input into clinical study designs and labeling claims that will support commercial objectives
  • Keep up-to-date on regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, scientific exchange and human subject protection, and inform stakeholders of new information that may impact Alnylam. Apply this knowledge to review of materials and communications
  • Participate in educating the organization on the U.S. regulatory framework and enforcement environment for advertising and promotion of prescription drugs and biologics
Qualifications
  • BS/BA degree (science or related discipline preferred); advanced degree desirable
  • Minimum of 4 yrs of professional experience in the biopharmaceutical or related industries, with at least 1 year of Regulatory Affairs advertising and promotion experience. Fellowship experience may be substituted
  • Knowledge of U.S. laws, regulations, guidance documents, enforcement actions, and industry standards related to communications about prescription drugs and investigational treatments
  • Understanding of clinical study design and statistical analyses, and their importance in assessment of claims
  • Strong interpersonal skills; must be solution-oriented and embrace Alnylam culture and approach to product communications
  • Must be detail-oriented and able to manage multiple priorities
  • Skilled in written and verbal communications
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

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Alnylam Pharmaceuticals