A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
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 the Healthcare business 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
- Ability to travel domestically and internationally up to 20%
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.