Open to candidates anywhere in the greater United States - Preferably based in the East Coast or Midwest

SUMMARY:

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.

ESSENTIAL FUNCTIONS:

• 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.

TRAVEL

• Willingness/Ability to travel ~10%+ domestically or internationally to business meetings and learning experiences.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $160,000 - $195,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site.  

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Accredited Bachelor's of Science 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
• Well versed in FDA Promotional Regulations, and specifically experience in the review and interpretation of materials directed to professional and direct to consumer audience.
• 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 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        
• The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

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
• Degree in a Science Field (Ph.D., PharmD)
• Experience in creation and launch of DTC campaign materials, including television commercials, social media, and/or patient and advocacy materials is beneficial.