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.
Responsibilities- Provide oversight and review of product and disease state education materials for consistency with approved labeling and alignment with applicable FDA regulations and guidances. Provide strategic support to the business and alternative solutions to challenges in order to achieve desired outcomes.
- Member of multi-disciplinary teams such as Copy Clearance Committees, Global Regulatory Teams, Global Labeling Teams; chairperson for Copy Clearance Committee.
- Maintain up-to-date knowledge of FDA laws, regulations and guidances, as well as the compliance environment as it relates to advertising and promotion of pharmaceutical products. Advise appropriate departments within the company of these requirements. Establish and revise procedures to ensure compliance with these requirements.
- Provide training in FDA regulations for advertising and promotion to employees and agents of Alkermes.
- Lead efforts to minimize complexity of review processes.
- Build and maintain strong relationships with internal customers including Marketing, Marketing Operations, Legal, and Medical.
- Serve as primary contact for OPDP for assigned products and ensure timely and accurate submission of product promotional materials to FDA under Form FDA-2253.
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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Skills Required
- Bachelor's degree in a health- or science-related field and/or an advanced degree
- At least 10 years of Regulatory Advertising and Promotion Review experience
- Applied knowledge of applicable FDA laws, regulations, guidance, and industry standards
- In-depth understanding of clinical trial design and interpretation of clinical data
- Ability to develop strategies based on emerging trends
- Ability to communicate business issues across all organizational levels, negotiate business decisions, and drive compliance solutions
- Strong interpersonal skills
- Strong written and verbal communication skills
- Ability to communicate complex issues clearly and concisely
- Willingness to travel up to 20%
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
