Fellowship - Regulatory Affairs - Therapeutic Area

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 Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program based in Plainsboro, New Jersey. This fellowship is intended to provide experience for Doctors of Pharmacy within the pharmaceutical industry with a focus on Regulatory Affairs for prescription drugs and devices at Novo Nordisk Inc. The fellow will gain the skills needed to pursue a career within the pharmaceutical industry where their education and experience can make a significant contribution to satisfying business needs and achieving company goals.
As part of this one-year fellowship, the fellow will gain experience in Regulatory Affairs, specifically in the Therapeutic Area with a track for experience in Advertising and Promotion. The fellow will learn about FDA regulations, including compilation and submission of any required documents to FDA.
Relationships
The fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout the one-year program. Additional key internal relationships include global and US stakeholders in other areas of Regulatory Affairs, as well as those who are part of the promotional review process.
External relationships include potential interaction with FDA personnel regarding assigned projects and roles.
Essential Functions
General

• All fellows will complete a fellowship project for presentation to the Regulatory Affairs department and/or at a key conference/congress.
• Additionally, fellows may be asked to attend other relevant scientific conventions, regulatory conferences, and other travel as required for business needs related to fellow projects.
• The fellow will have regular contact with cross functional areas including: Commercial, Safety, Medical, Clinical Operations, and Legal. This structured approach will allow for a broad, hands-on experience enabling the fellow to gain the skills needed to pursue a career within the pharmaceutical industry.

Therapeutic Area

• Assist in preparation of regulatory documents.
• Work with global stakeholders from headquarters on preparation of submissions to FDA.
• Assist in review or development of labeling for marketed products and new products as assigned.
• Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents.
• Prepare and compile content plans for submissions to an investigational or marketing application in accordance with applicable SOPs and FDA regulations/guidances.
• Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions.

Advertising and Promotion

• Gain understanding of how prescription drug clinical studies, regulatory strategy, and FDA-approved labeling affect promotion and advertising.
• Maintain up-to-date knowledge of key laws, regulations, guidances, and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices and advise on these requirements.
• Be involved in review of prescription drug advertising and promotional materials and the required submission of final promotional materials to FDA on Form 2253.
• Learn the importance of regulatory intelligence to help inform the prescription drug advertising and promotion landscape.

Physical Requirements

• 10%-15% overnight travel required.

Qualifications

• Received a Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy within the last three years.
• Strong academic track record preferred.
• Demonstrated leadership capabilities.
• Presentable, highly articulate, goal-oriented, honest, with high integrity and strong ethics.
• Track record of teamwork, innovation and project management.
• Ability to think critically, strategically, and independently.
• Possess good communication skills, both oral, written and presentation.
• Demonstrate an ability to perform medical accuracy review with strong attention to detail.
• Proficiency in Microsoft Office software applications such as PowerPoint, Excel and Word and overall computer skills with knowledge of literature search technique required.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
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.