Fellow - Multidisciplinary (Multiple Positions) Job Job in New Jersey (NJ), Regulatory Affairs Career, Full Time Jobs in Novo Nordisk Inc.
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Fellow - Multidisciplinary (Multiple Positions) Job job in Plainsboro

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Novo Nordisk Inc. jobs
New Jersey (NJ), Plainsboro
Job Code:  58772BR
Employer:  Novo Nordisk Inc.
Category:  Regulatory Affairs
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  Plainsboro
10/09/2018

Description


About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc. (NNI) 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 Food & Drug Administration (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 Postdoctoral Multidisciplinary Fellowship is a two-year, experiential program based in Plainsboro, New Jersey. This fellowship is intended to provide an experience for a Doctor of Pharmacy within the pharmaceutical industry. The Fellow will contribute to different functional areas at Novo Nordisk Inc., where a PharmD's training and expertise will provide value to the organization. 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 customer needs and achieving company goals.

During this one-year fellowship, the Fellow will gain experience in three concentrated focus areas: one year in Medical Information and two 6 month rotations, or a 1 year rotation in another functional areas within Novo Nordisk Inc.

Relationships
The Fellow will report to their Fellowship Manager/preceptor within Medical Information throughout the two-year program and will also have a reporting relationship with a manager in the respective functional areas during their rotations. Additional key internal relationships may include CMR Leadership, Medical Affairs, CMR Training, Clinical Trial Management, and Clinical Development.

Essential Functions
General
  • Each Fellow will have regular contact with cross functional areas including Regulatory Affairs, Marketing, etc. This structured approach will allow for a broad, "hands-on" experience enabling the Fellows to gain the skills needed to pursue a career within the pharmaceutical industry
  • All Fellows will complete a Fellowship project for presentation at a key conference/congress. Additionally, Fellows may be asked to attend other relevant scientific conventions, national team meetings and other travel as required for business needs related to fellow projects as appropriate
  • Multidisciplinary Fellows will gain experience for 12 months in Medical Information and two additional 6-month rotations, or a 1 year rotation in one of the functional areas listed below

Medical Information
  • Gain an understanding of the role and responsibilities of a Medical Information Therapeutic Manager in a pharmaceutical industry setting
  • Develop the skills needed to provide accurate, fair balanced, and current medical and technical information about Novo Nordisk products to healthcare professionals, consumers, managed care organizations and health systems
  • Develop competencies in 1) responding to inquiries in both verbal and written forms, and 2) tailoring the responses to the target audience
  • Update or create standard Medical Information letters and perform literature searches to stay abreast of the latest scientific information in relevant areas


Medical Writing (option)
  • Gain an understanding of guidelines for ethical publication practice and reporting of clinical trial data
  • Gain exposure to regulatory writing processes
  • Provide medical writing support to authors in the development of scientific publications and scientific presentations
  • Coordinate internal medical review and author review of publications
  • Assist medical writing members in the preparation of regulatory documents
  • During the development of scientific documents, interact and collaborate with internal and external stakeholders including authors, clinicians, biostatisticians, publication planning group, trial managers, regulatory affairs professionals and medical communications agencies
  • Attend relevant meetings, such as publication planning group meetings, authors' meetings, and project meetings


Medical Education (option)
  • Gain an understanding of industry regulations pertaining to independent medical education and ensure that all programs are funded and executed in compliance with these guidelines
  • Participate in the review and evaluation of proposals and grant requests submitted by various medical education companies and accredited providers. Analyze needs assessments, educational objectives and program content in submitted grant requests to ensure alignment with medical education strategy
  • Project manage assigned medical education programs to ensure successful implementation of programs within budget
  • Complete medical accuracy review of live and enduring programs, such as web-based programs, monographs and journal supplements, after their dissemination to intended audiences

Product Safety (option)
  • Collaborate with Product Safety case management and functional groups to learn about general pharmacovigilance related activities
  • Gain an understanding of basic FDA/Global Health Authority regulations related to capturing and reporting of safety information
  • Collect verbal and written safety information from physicians, investigators, healthcare professionals, consumers and company sales and field personnel for post-marketing and clinical trial adverse event reports
  • Perform and prioritize data entry and verification of safety data into the required complaint and safety databases based on internal and external timelines
  • Identify and submit relevant follow-up queries to obtain additional/missing safety information


Physical Requirements
10%-15% overnight travel required.

Qualifications
  • A Doctor of Pharmacy degree from an Accreditation Council for Pharmacy Education ( ACPE)-accredited college of pharmacy with strong academic track record required Demonstrated leadership capabilities
  • Possess good communication skills, both oral, written and presentation
  • Presentable, highly articulate, goal-oriented, honest, with high integrity and strong ethics.
  • Proficiency in PowerPoint, Excel and MS word software applications and overall computer skills with knowledge of literature search techniques required
  • Track record of team work, innovation, and project management
  • Participate in Medical Information projects or task forces
  • Participate in product training for sales representatives and in-house colleagues
  • Be the medical accuracy reviewer as needed for promotional pieces undergoing review by the Promotional Review Board (PRB)


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.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

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.

Requisition ID: 58772BR
State/Provinces: Plainsboro
Job Category: Regulatory

ref: (58772BR)
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