Associate Director Promotion Compliance and Scientific Messaging

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

Remote/Commuter Opportunity - Open to candidates within the United States

SUMMARY: The Associate Director, Advertising & Promotion Compliance plays a critical role in ensures compliant and effective promotion and scientific messaging of Lundbeck's U.S. pharmaceutical products throughout their lifecycle. The role provides regulatory strategic and promotional direction to support product launches, lifecycle management, and global product messaging as requested. By ensuring alignment with FDA regulations, corporate standards, and product labeling, the responsibilities include regulatory review, approval, and submission of promotional and medical materials, as well as maintaining productive relationships with internal partners and FDA/OPDP.

The position also leads or supports regulatory training initiatives and serves as a resource on advertising and promotion regulations.

ESSENTIAL FUNCTIONS:

• Provide regulatory reviews of product labeling, advertising and promotional materials for accuracy and compliance with FDA regulations, and global guidelines as appropriate. Manages, reviews and represents regulatory perspectives at promotional review meetings to negotiate accurate, compliant and competitive final materials. Identifies risk, problem-solves, and delivers solution-oriented strategies. Manages/supports related FDA submission activities in compliance with current regulations.
• Provide Regulatory strategic guidance on new commercial concepts, HCP/DTC commercial materials, scientific messaging content, market access materials, OPDP advisory processes, consistent with FDA label tactics, and health care economic communications, to identify and mitigate risk and ensure compliance.
• Provide Regulatory promotional and scientific communication leadership on brand and life cycle management teams, process optimization efforts, development and collection of metrics, and further enhancement of cross functional interactions.
• Provide internal and external training on departmental initiatives and for compliance purposes.
• Monitor the external regulatory climate to inform internal customers of potential impact on long-term objectives;
  Represent Regulatory Affairs at cross-functional team meetings to communicate and implement agreed-upon regulatory strategy and compliance needs.
• Develop and facilitate improvement efforts for internal promotional material review processes, through cross functional collaboration and leadership influence, to support necessary compliance enhancements and departmental efficiencies, including global process collaboration.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Accredited bachelor's degree
• 8+ years of experience in Regulatory, R&D or related area within the pharmaceutical, biotech or medical device industry with at least 4 of those years within either advertising/promotion or Regulatory experience specific to neurology, migraine or biologics
• Well versed in FDA Promotional Regulations and specifically experience in the review and interpretation of materials directed to healthcare professionals and direct-to-consumer audiences.
• Experience in the review of technical content and assessment of product claim feasibility, in alignment with guidance associated with the communication of health care economic information and data analysis for consistent with label usage.
• Expertise in navigating FDA interactions, including experience with FDA negotiations and/or OPDP communications.
• Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and promotional regulations as they relate to drugs and/or biologics
• Proficiency in identifying regulatory risk…