Associate Director, Regulatory Advertising and Promotion

Alkermes

3d•Hybrid

About The Position

Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Associate 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. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

Requirements

High level of applied knowledge of applicable FDA laws, regulations, guidance, and industry standards.
Strong understanding of clinical trial design and interpretation of clinical data.
Strong interpersonal skills, strong communication skills (written and verbal).
Shape 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.
Bachelor’s degree in a health or science-related field and/or an advanced degree.
A minimum of 7 years Regulatory Advertising and Promotion Review experience.

Nice To Haves

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.

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 and devices.
Advise appropriate departments within the company of these requirements.
Participate in development of procedures to ensure compliance with these requirements.
Provide training in FDA regulations for advertising and promotion to employees and agents of Alkermes.
Participate in 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.