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? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!
Under the supervision of departmental management, the Associate Director, Advertising and Promotion, Strategy and Compliance (US RA): provides regulatory advertising and promotional direction for the successful launch and lifecycle management (LCM) of Lundbeck US drug products; helps ensure compliance with regulatory requirements and corporate standards; and maintains positive communications with internal commercial partners and FDA contacts. More specifically, this position provides regulatory label strategic direction and promotional guidance to internal business partners in order to facilitate the commercial brand plan, including executing the regulatory review, approval, and submission of advertising and promotional materials to ensure consistency with product labeling, current FDA regulations, guidance documents and internal SOPs. This role is responsible to lead and/or help to facilitate departmental regulatory training initiatives both internal and external, and provide research and communication concerning advertising and promotion regulations.
- Provides regulatory review of product labeling, advertising and promotional materials for accuracy and compliance with FDA regulations. Manages, reviews and represents regulatory perspective at PARC meetings to negotiate accurate, compliant and competitive final materials. Identifies risk, problem-solves, offers solutions. Manages/supports related FDA submission activities in compliance with current FDA regulations.
- In close cooperation with regulatory agents, coordinates regulatory promotional submissions; prepares submissions in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.
- Provides Regulatory strategic guidance on new concepts, DTC advisory processes, Consistent with FDA Label tactics, and Payor Communications in order to identify and mitigate risk.
- Provides Regulatory leadership on brand and life cycle management teams, process optimization efforts, development and collection of metrics, and further enhancement of cross functional interactions.
- Provides internal and external training on departmental initiatives and for compliance purposes.
- Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives; Represents RA at cross-functional team meetings to represent agreed-upon RA positions.
- Develops and facilitates improvement efforts for internal promotional material review processes, through cross functional collaboration and leadership through influence, in order to support necessary compliance enhancements and departmental efficiencies.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited BS Degree
- 8+ years of experience in Regulatory, R&D or related area within the pharmaceutical, medical device or biotech industry with at least 4 of those years within either advertising/promotion or Regulatory experience specific to neurology, migraine, or biologics
- Experience and understanding of FDA Promotional Regulations, specifically of Direct to Consumer (DTC) regulations and Consistent with FDA Label guidance
- Expertise in navigating FDA interactions, including experience with FDA negotiations and/or OPDP communications.
- Experience in creation and launch of DTC campaign materials, including television commercials, social media, and patient and advocacy materials.
- 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 and negotiating/resolving differences
- Demonstrated leadership capabilities, both with direct reports, as well as leading by influence
- Attention to detail and strong organizational skills with the ability to meet multiple deadlines
- Demonstrated ability to work in a multi-disciplinary team
- Excellent oral and written communication skills, including ability to articulate regulatory positions
- High proficiency in MS Word, MS Excel and Adobe Acrobat
- Proficient in Veeva or comparable document management system
- High Proficiency in time management and demonstrated ability to work independently
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Accredited BS Degree in Science, Chemistry, Pharmacy or related subject study/experience
- Knowledge in the Regulatory support of both biologics and small molecules
- Terminal Degree in a Science Field (Ph.D., PharmD)
- Proficiency in FDA Promotional Regulations, specifically of Direct to Consumer (DTC) regulations and Consistent with FDA Label guidance
- Willingness/Ability to travel ~10%+ domestically to business meetings and learning experiences.