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.
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.
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.
Unquestionable ethics, professional integrity and personal values consistent with Sanofi values.
Capable of managing therapeutic product projects on topics specific to the functional area. Is able to balance managing these projects with day-to-day duties, ensuring participation from other members of the department as needed.
Is able to establish priorities and timelines to effectively self-manage workload. Is able to multi-task exceptionally well.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Sanofi is hiring: Senior Director, Global Advertising and Promoti...