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Director - Regulatory Affairs Advertising & Promotion

Employer
Novo Nordisk
Location
Plainsboro, NJ
Start date
Nov 28, 2023

View more

Discipline
Marketing, Advertising, Regulatory
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Best Places to Work

Job Details

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

The Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies.

 

Relationships

Develop and maintain positive rapport and working relationships with Regulatory Affairs, Legal, Commercial, and other cross-functional stakeholders to accomplish company goals. Establish strong and positive working relationship with OPDP reviewers.

Report to Senior Director, Regulatory Affairs - Advertising & Promotion.

 

Essential Functions

  • Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape
  • Assess risk and advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures
  • Maintain up-to-date knowledge of laws, regulations, and policies enforced by Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices
  • Apply regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks
  • Creatively advise on the development of product messages and materials across multiple functional areas, and propose regulatory strategy and solutions to challenging promotional concepts that meet business objectives
  • Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk
  • Collaborate with Regulatory Affairs colleagues to provide input to study designs or US labels regarding feasibility of promoting potential data/claims
  • Participate/assist in US labeling negotiations as necessary. Ensure that changes in US Prescribing Information are reflected in current promotion and advertising in a timely manner
  • Play a critical role in pre-launch and launch activities as necessary, including the development of launch materials/new claims by collaborating with Commercial, Medical and Legal
  • Advise in the development and implementation of strategies to maintain efficient and compliant Promotional Review Board (PRB) process
  • Serve as a primary regulatory advertising and promotion reviewer for assigned products
  • Liaison with OPDP regarding advertising and promotion for assigned products. Oversees preparation and submission of draft introductory materials to OPDP for advisory comment
  • Ensure company compliance with FDA requirements, including timely and accurate submission of advertising and promotional materials to OPDP with FDA Form 2253
  •  

    Qualifications

  • Bachelor’s degree in a health-or science related field required; advanced degree preferred
  • A minimum of 10 years of pharmaceutical/biologics industry experience required
  • Ideally 6 years of promotional review experience preferred
  • Experience with promotion of a product with conditional approval (Subpart H) highly preferred
  • Experience and knowledge of current FDA requirements; experience handling interactions with FDA
  • Ability to establish sound working relationships with individuals possessing different levels of skill and background is necessary
  • Excellent communication and leadership skills are essential
  • Ability to effectively communicate business issues across all levels of the organization, negotiate business decisions, evaluate risk, and work toward solutions
  •  

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

     

    At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

     

    Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

     

    If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Telephone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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