A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Head of U.S. Regulatory Advertising & Promotion is accountable for providing leadership, influence and support of all advertising and promotion activities for EMD Serono in the U.S. This position will ensure both an efficient and compliant promotional review process and execution for all our products in the U.S. By effectively partnering with internal and external stakeholders, the Head of U.S. Regulatory Advertising & Promotion will drive and achieve the goal of delivering accurate, balanced, and substantiated information about products to our customers (patients, providers, payers, and health authorities). This position reports locally to the Head of Regulatory Affairs U.S., and to ensure we provide a holistic approach to product lifecycle management as well as approach the function with a global perspective in mind, this position has a dotted line to the Head of Global Labeling, Advertising & Promotion. This will ensure alignment to global standards as well as processes and systems in advertising & promotion review, while addressing the regional business needs and requirements.
- Accountable for all Regulatory activities related to U.S. advertising & promotion (A&P); establish a best-in-class A&P local function.
- Provide expert input into promotional regulatory strategies to ensure compliance with FDA, FTC, and SEC requirements for A&P, as applicable.
- Build a strong relationship with the FDA’s Office of Prescription Drug Promotion (OPDP)
- Lead the PSMR process for Regulatory Affairs in the U.S. and chair the U.S. cross functional platform of alignment on A&P materials
- Establish and maintain local policies and SOPs that are aligned globally to ensure the creation, review and approval of medical, scientific and promotional materials comply with the company’s code of conduct and relevant external national / regional advertising & promotional regulations or codes of practice
- 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 the FDA, FTC, and SEC, where applicable
- Provide Regulatory review and guidance for promotional press materials and scientific disclosures to media customers
- Support training on U.S. regulatory issues pertaining to the promotion of Company Products through the global Regulatory network
- Project and forecast resource demands related to U.S. A&P activities to ensure business continuity
- Contribute to the global strategy for 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.
- 15+ years’ experience in the biopharma industry, with at least 10 years within regulatory promotion & advertising
- Proven track record of effective collaboration with the FDA, demonstrated ability to act as a credible, influential, respected spokesperson during interactions with the agency, with appropriate and proactive communication 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
- Demonstrated leadership experience
- Demonstrated track record of success contributing in a globally oriented environment
- Understanding of small molecules, biologics processes, devices, diagnostics and manufacturing aspects of product development
- Skilled in presenting management with recommendations that reflect full consideration of available options
- 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 fulfil 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 https://jobs.vibrantm.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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.