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 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. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
The Associate Director, Global Regulatory U.S. Advertising and Promotion is the regulatory lead responsible for promotional activities for the U.S. This individual will be a key reviewer for internal, training, and external materials and will be the point of content with FDA’s Office of Prescription Drug Promotion for communications including subpart H pre-clearance materials. This individual independently represents the Regulatory compliance voice on such matters and acts as an internal expert to advise on the FDA requirements while working closely with all stakeholders to reach consensus on approved messages and materials. The Associate Director facilitates the generation of new and revision of product labeling with key local and global disciplines as well as external alliance partners and serves as the expert for the regulatory history for labeling and promotional communications with FDA.
- Provides regulatory direction in the development and approval of compliant advertising and promotional materials, disease state education, field training materials, and external communications
- Maintains a thorough understanding of OPDP requirements as well as a keen awareness of enforcement trends and is confident in their analysis and application to compliance assessments
- Prepares presentations and trains other departments and outside speakers
- Engages with key stakeholders and teams in the creation and execution of FDA compliant programs for product sampling, speaker events, medical congresses, launches, market research and competitive analysis.
- Leads efforts to create, modify, and review labeling documents, including prescribing information, patient labeling, and packaging/artwork content and device instructions for use with attention to competitive positioning
- Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in medical and marketing communications and activities
- Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during promotional and scientific medical reviews
- Serves as the primary point of contact with the FDA Office of Prescription Drug Promotion on all matters including subpart H clearance
- Leads US Labeling Working Group for new product labeling and works closely with the Global Labeling Team on alignment with the Core Data Sheet. Co-ordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts
- Provides upon request analysis of competitor labeling in the relevant therapeutic area
- Responsible for continuous quality and compliance throughout the packaging labeling process
- Member on project teams and regulatory sub-teams, as appropriate
- Prepares SOPs, work instructions and provides related training presentations and Q&A sessions
Who You Are:
- BS degree in life sciences or related scientific discipline
- A minimum of 5 years experience in Regulatory Affairs (3 in promotion and/or labeling strategy), Nonclinical Research, or Clinical Research, specifically, in the submission of regulatory filings for drug/biologic or device products.
- Working knowledge of FDA and international Biologics/Drug regulations; experience with IND, CTA, BLA, NDA, MAA, eCTD, and 2253 regulatory submissions.
- Strong organizational, interpersonal and written/verbal communication skills are required.
- Ability to travel domestically and internationally is required.
- Advanced degree and/or RAC.
- Experience with combination (i.e., drug/device or biologic/device), biologics or drug products and oncology is preferred.
- Ability to prioritize and multi-task projects independently is preferred.
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.