Senior Manager, Regulatory Affairs in Advertising
2 weeks ago
Position Overview:
Under the guidance of the Senior Director of Regulatory Affairs for Advertising, Promotion & Labeling, the Senior Manager, Regulatory Affairs in Advertising will play a pivotal role in delivering comprehensive regulatory guidance concerning the dissemination of information related to designated Alkermes products and associated medical conditions. This position collaborates closely with teams across Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments to support initiatives and evaluate external communication materials. The role is focused on fostering constructive relationships within and between departments regarding promotional matters. Additionally, the position involves interaction with regulatory bodies and contributing to negotiations with health authorities as required.
This role is structured as a hybrid position, allowing for both remote and onsite work.
Key Responsibilities:
- Oversee and assess product and disease state educational materials to ensure alignment with approved labeling and compliance with relevant FDA regulations and guidelines. Provide strategic insights to the business and propose alternative solutions to overcome challenges and achieve desired outcomes.
- Participate as a member of cross-functional teams such as the Copy Clearance Committee, Global Regulatory Team, and Global Labeling Team; serve as chairperson for the Copy Clearance Committee.
- Maintain current knowledge of FDA laws, regulations, and guidelines, along with the compliance landscape concerning the advertising and promotion of pharmaceutical products and devices. Advise relevant departments on these requirements and assist in developing procedures to ensure adherence.
- Deliver training on FDA regulations related to advertising and promotion to Alkermes employees and agents.
- Engage in initiatives aimed at simplifying review processes.
- Establish and nurture strong partnerships with internal stakeholders, including Marketing, Marketing Operations, Legal, and Medical.
- Act as the primary liaison for the Office of Prescription Drug Promotion (OPDP) for assigned products, ensuring timely and accurate submission of promotional materials to the FDA.
Essential Skills:
- Extensive knowledge of applicable FDA laws, regulations, guidance, and industry standards.
- Strong grasp of clinical trial design and the interpretation of clinical data.
- Ability to formulate and refine strategies based on emerging industry trends.
- Effective communication skills to convey business issues across all organizational levels, negotiate decisions, and collaborate towards compliance solutions.
Basic Qualifications for Senior Manager:
- Bachelor's degree in a health or science-related discipline and/or an advanced degree.
- A minimum of 7 years of experience in Regulatory Advertising and Promotion Review.
Preferred Qualifications:
- Willingness to travel up to 20% may be necessary.
- Exceptional interpersonal and communication skills (both written and verbal).
- Capability to articulate complex issues in a clear and concise manner.
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PDN-9b285fcd-871d-422a-9d7f-5b0d97ef0f13-
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