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Head, Global Regulatory Advertising & Promotion

Posted on Dec 9, 2018 by Merck KGaA

Not Specified, PR
Design & Creative
Immediate Start
Annual Salary
Your Role: The Head of Global Regulatory Advertising & Promotion leads and manages a regulatory team responsible for providing leadership, influence and support for all advertising and promotional activities for the company's prescription and non-prescription drug products. This will ensure a both efficient and compliant promotional review process and execution for all our products across the globe. By effectively partnering with internal and external stakeholders, the team helps to achieve the goal of delivering accurate, balanced, and substantiated information about products to our customers (patients, providers, payers, and health authorities).. 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. Oversee the Company A & P Academy aimed at developing best practices for A & P in all countries where Merck Healthcare operates. Liaise and network with relevant positions within and outside R&D for questions and developments related to A & P. Who You Are:. 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. Glassdoor has millions of jobs plus salary information, company reviews, and interview questions from people on the inside making it easy to find a job that's right for you.

Reference: 599215923