Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, 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 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.
This is a hybrid position, onsite at our Waltham, MA office.
Key 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 Committee, Global Regulatory Team, Global Labeling Team; 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 and devices. 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.