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Compliance and Regulatory Expert

il y a 1 mois

Paris, Île-de-France Alnylam Pharmaceuticals Inc. Temps plein

Job Overview

The Director of U.S. Advertising and Promotion will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and other audiences. This role requires a deep understanding of U.S. laws and regulations, as well as experience in managing individuals and/or teams.

Key Responsibilities

  1. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance, and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange.
  2. Regulatory Reviewer on Commercial and Medical Review Boards.
  3. Act as Alnylam's liaison to the FDA's Office of Prescription Drug Promotion (OPDP), including preparing correspondence for advisory comment submissions and conducting negotiations.
  4. Support achievement of corporate goals by using flexible and innovative approaches while appropriately mitigating risk.
  5. Serve as internal expert on U.S. laws and regulations, FDA guidance documents, and enforcement actions.
  6. Contribute to culture of compliance at Alnylam by educating colleagues on the regulatory framework and environment, providing assessment of risk for proposed communication tactics and strategies, and participating in development of policies and procedures.
  7. Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, scientific exchange, and human subject protection, and analyze and communicate their relevance to Alnylam.
  8. Provide advice regarding clinical study design elements and labeling needed to support target product profiles and desired commercial claims.
  9. Help build USAP team and capabilities, including development of processes and best practices.

Requirements

  1. BS/BA degree; advanced degree desirable but not required.
  2. 10 years of relevant professional experience, including at least 3 years in Regulatory Affairs in a U.S. advertising and promotion role.
  3. Expert in U.S. law, regulations, and FDA guidance documents related to communications about prescription drugs, investigational treatments, and disease education.
  4. Experience with a product launch or launches and in communicating with OPDP or APLB, including submissions for advisory comment, highly desirable.
  5. Prior experience in supporting products for prevalent diseases a plus.
  6. Demonstrated understanding of the importance of clinical study design and statistical principles and analyses to assessment of permissible claims.
  7. Highly skilled in written and verbal communications, including a facility for understanding and communicating scientific, medical, and legal concepts and information.
  8. Experienced in managing individuals and/or teams preferred.