Job description

Serves as the lead reviewer for medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads cross-functional collaboration to ensure appropriate reviews take place and timely submissions are made to OPDP. Work closely with the Director, Regulatory Ad Promo to formulate the strategic direction and develop process improvements for the Regulatory Ad/Promotion function. Proactively reviews regulatory promotional guidelines and untitled/warning letters; assesses phase IV clinical trial design with regard to possibilities for use in proactive or reactive marketing or medical communication. Assesses labeling changes for potential impact on Ad/Promo and and medical communications materials.

Your Contributions (include, but are not limited to):

Assumes a leadership role in the PRC Process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines for select product, disease state, and all medical education materials
Responsible for timely and accurate review, and timely submission of promotional materials (i.e. FDA 2253 submissions)
Independently represents Regulatory Affairs on the Medical Review Committee (MRC) and be responsible for conducting the regulatory review of materials for assigned products/programs intended for use by the field medical team
Track and evaluate FDA guidance, policies and the overall regulatory environment and must be able to assess and communicate potential risk and impact to Sr. Leadership
Develop and maintain a business partnership environment between Regulatory Affairs, PRC and MRC partner functions in the review and approval of advertising and promotional materials
Actively manages communications to Regulatory management, and ensures promotional claims are in compliance with terms of approved product registrations, current labeling, applicable laws, internal policies and external regulations
Proactively assesses advertising and promotion-related processes and procedures to enhance efficiencies and compliance
Identify and recommend/implement policy and/or process changes as needed in partnership with Director, Regulatory Ad/Promo
Maintain standard operating procedures and department working practices
Mentors and develops junior level team members
Other duties as assigned

Requirements:

BS/BA degree in Life/Health Sciences or related field and 10+ year's of Regulatory Affairs experience at a biotech, pharmaceutical or device company, including significant experience in Advertising & Promotion process management OR
Master’s degree in Life/Health Science or related field and 8+ years of similar experience as noted above
Emerging as an internal thought leader with technical and/or business expertise
Applies in-depth knowledge of own area of expertise to solve problems, with guidance from Director, Regulatory Ad/Promo on complex/high risk matters
Applies expertise to manage critical projects and/or relationships
Integrates analysis of business objectives and strategic direction to resolve problems and recommend solutions
Has input into short-term strategy and may be involved in long-term strategy on a functional level
Strong communications, problem-solving, analytical thinking, influencing skills
Demonstrated ability to work independently with minimal direction, including functional representation within teams and committees in order to attain group goals
Proven track record and experience in Advertising & Promotional review committees with a thorough understanding of FDA guidance and regulations
Extensive knowledge of electronic document management systems (e.g. Veeva Vault or similar)
Advanced in Microsoft Office programs and Adobe Professional.