Director, Regulatory Affairs
2 settimane fa
Job Description - Director, Regulatory Affairs U.S. Advertising and Promotion (USAP) (230626)
The Director for U.S. Advertising and Promotion (USAP) 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. A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with U.S. laws and regulations and Alnylam policies. The Director will help build the USAP team and capabilities and may be responsible for supervising or mentoring more junior team members and fostering their professional development. The Director for USAP will report to the Senior Director of U.S. Advertising and Promotion.
Summary of 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, for assigned product(s).
- Regulatory Reviewer on Commercial and Medical Review Boards for assigned product(s).
- Act as Alnylam’s liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) for assigned product(s), 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.
- Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA.
Qualifications
- BS / BA degree; advanced degree desirable but not required.
- 10 years of relevant professional experience, including at least 3 years in Regulatory Affairs in a U.S. advertising and promotion role.
- Expert in U.S. law, regulations, and FDA guidance documents related to communications about prescription drugs, investigational treatments, and disease education.
- Experience with a product launch or launches and in communicating with OPDP or APLB, including submissions for advisory comment, highly desirable.
- Prior experience in supporting products for prevalent diseases a plus.
- Demonstrated understanding of the importance of clinical study design and statistical principles and analyses to assessment of permissible claims.
- Highly skilled in written and verbal communications, including a facility for understanding and communicating scientific, medical, and legal concepts and information.
- Experienced in managing individuals and/or teams preferred.
Ways of Working
- Must be comfortable providing recommendations and making decisions in areas that are often “gray.”
- Able to influence without authority in a matrix environment.
- Strong interpersonal skills, with ability to collaborate across disciplines to solve problems.
About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.
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