About this role
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas. Partners with other personnel in Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of brand initiatives and review of external communications materials. Develops and maintains positive working relationships within and across departments in relation to promotional issues. Communicates with FDA and contributes to health authority negotiations as necessary.
Skills:
- High level of applied knowledge of applicable FDA laws, regulations, guidance, and industry standards.
- In depth understanding of clinical trial design and interpretation of clinical data.
- Shape and develop strategies based on emerging trends.
- Ability to communicate business issues across all levels of the organization, negotiate business decisions, and work toward solutions to drive compliance.
Basic Requirements:
- Bachelor’s degree in a health or science-related field and/or an advanced degree.
- A minimum of 10 years Regulatory Advertising and Promotion Review experience.
Preferred Requirements:
- Travel of up to 20% may be required.
- Strong interpersonal skills, strong communication skills (written and verbal).
- Ability to communicate complex issues clearly and concisely.
The annual base salary for this position ranges from $223,600 to $239,630. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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