Senior Director, Global Advertising and Promotion Therapeutic Area Head

Job Title: Senior Director, Global Advertising and Promotion Therapeutic Area Head

Location: Bridgewater, NJ / Cambridge, MA (must adhere to hybrid working schedule of being onsite 3x per week)

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

In this role, you will be responsible for the oversight of regulatory review of advertising, promotion, medical, media relations and other internal and external communications related to company products in one or more therapeutic areas. You will play an important role in mentoring and developing direct reports for future leadership roles. You will also provide input into the global organization for promotional strategies, including launch strategies. Additionally, you will be the primary therapeutic area liaison with FDA’s Office of Prescription Drug Promotion (OPDP) for drugs, Advertising & Promotional Labeling Branch (APLB) for biologics, and Division of Premarket and Labeling Compliance (DPLC) for medical devices, as applicable.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• In conjunction with the Global Regulatory Affairs' Head of Global Advertising & Promotion, recommend and contribute to the development of strategic objectives across assigned therapeutic areas.

• Contribute to the maintenance and enhancement of strategic relationships with customers.

• Ensure that the regulatory environment is continually monitored for new regulations/guidance and applicable enforcement activities.

• Oversee staff implementation of U.S. Regulatory strategies (e.g., submissions, product defense, labeling development, FDA enforcement, clinical trial support, FDA contacts).

• Provide opportunities for direct reports that contribute to Global Advertising & Promotion staff development.

• Contribute to the maintenance and enhancement of strategic relationships with customers and direct activities to influence the external regulatory environment in accordance with GRA priorities. 

• Establish and develop key internal relationships with R&D and Regulatory Development to foster open communication and teamwork.

• Ensure alignment and consistency in Global Advertising & Promotion policy application within and across therapeutic products; taking into account the totality of product-related and company activities.

• Ensure therapeutic product relationships with FDA are established and maintained.

• Performs other duties as assigned.

About You

Experience

• Successful track record in Regulatory Affairs with 7 -10+ years of relevant experience in Regulatory Advertising & Promotion within the pharmaceutical or medical device industry.

• Experience managing others is required.

• Possess a depth of experience dealing effectively with cross-functional groups, which may include Medical, Legal, Marketing, etc.

Education

• Bachelor’s degree from an accredited four-year college or university in a Life Sciences discipline or related scientific field.

• Advanced degree is highly preferred.

Technical Skills

• Extensive knowledge and understanding of complex medical and scientific subject matter.

• Possesses comprehensive breadth of technical knowledge in regulatory affairs and ensures dissemination of this knowledge to others throughout the organization.

• Ability to work well within cross-functional teams.

• Can demonstrate solid oral communication and writing skills.

• Understanding of the U.S. pharmaceutical market place, and familiarity with medical terminology.

• Understanding of Global Advertising & Promotion requirements preferred.

• Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.

• Develops collaborative relationships to f