The company operates within the Biotechnology sector.
Oversee the global advertising & promotional (A & P) team and develop the A & P function to be best-in class.
Provide expert input into promotional regulatory strategies to ensure compliance with the worldwide requirements for A and P, including but not limited to FDA's guidance on advertising & promotion
Build a strong relationship with the FDA's Office of Prescription Drug Promotion(OPDP) and serve as the health authority liaison on all matters related to A & P, globally.
Lead the MLR processes for Regulatory Affairs, serve as secretary for the MLR process and chair the US cross functional platform of alignment on A & P materials
Establish and maintain policies and SOPs that ensure the creation, review and approval of medical, scientific and promotional materials that comply with the company's code of conduct and relevant external national / regional advertising & promotional regulations or codes of practice (e.g. ABPI Code of Practice, FDA regulations, TGA Therapeutic Goods Advertising Code)
Provide input into risk mitigation strategies to inform and influence business leaders by monitoring and communicating factors and trends in the external environment related to advertising and promotion topics from FDA, FTC and other authorities actions
Provide Regulatory review and guidance for promotional press materials and scientific disclosures to media customers
Coordinate training on regulatory issues pertaining to the promotion of Company Products through the global Regulatory network
Bachelor's Degree in scientific or life sciences discipline or related required,
Advanced degree in scientific or life sciences discipline or related (PharmD, PhD, MD) strongly preferred.
Proven track record of effective collaboration with regulatory agencies
Actively engages colleagues, interacting broadly with other members of GRA Leadership Team, the R & D Executive Leadership Team, and the North American Leadership Team.
15+ years' experience in the biopharma industry, with at least 10 years within regulatory promotion & advertising
Demonstrated leadership experience
Demonstrated track record of success contributing in a globally oriented environment
Understand small molecules, biologics processes, devices, diagnostics and manufacturing aspects of product development
Demonstrated ability to act as a credible, influential, respected spokesperson during interactions with regulatory agencies, and ensure appropriate, proactive communication with agencies to assure expedient and efficient review of our promotional material.
Gravitas to negotiate within a highly matrixed environment to deliver complex messages and facilitate appropriate team decisions, insightful and forward thinking, ability to recognize, anticipate and review/discuss potential A & P challenges with teams
Skilled in presenting management with recommendations that reflect full consideration of available options
Communicate with clarity, impact, and passion tailored to the audience
Ability to travel domestically and internationally up to 20%