Regulatory Affairs Director
il y a 4 semaines
Job Summary
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
- 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.
- Regulatory Reviewer on Commercial and Medical Review Boards.
- 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.
- Support achievement of corporate goals by using flexible and innovative approaches while appropriately mitigating risk.
- Serve as internal expert on U.S. laws and regulations, FDA guidance documents, and enforcement actions.
- 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.
- 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.
- Provide advice regarding clinical study design elements and labeling needed to support target product profiles and desired commercial claims.
- Help build USAP team and capabilities, including development of processes and best practices.
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