Job Description

About the Department

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

The Position

The Principal Medical Writer is an expert in medical writing and performs work independently with minimal-to-no supervision. The Principal Medical Writer will work closely with cross-functional project teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Principal Medical Writer will provide high level strategic input into development plans, study designs, and regulatory submissions.

Relationships

The Principal Medical Writer reports to a Director of Medical Writing.

The Principal Medical Writer is expected to develop and maintain a strong network of internal relationships with global and local cross-functional study teams.

The Principal Medical Writer should be seen as a key resource for medical writing expertise and provides active leadership on local and global project teams, as needed.

The Principal Medical Writer will provide mentoring and direction to less-experienced medical writers, as needed.

Essential Functions

• Provides strategic input into documents and plans to support clinical operations and regulatory submissions across a range of development programs and therapeutic areas:
  • Uses professional experience to provide advanced input into study designs, analysis plans, and regulatory submissions/ applications
  • Analyzes proposed study plans and related documents for their ability to deliver the information required by the target audience
  • Collaborates with others to develop key messages for complex clinical/regulatory documents
• Authors, reviews, and/or edits documents to support clinical trials and regulatory submissions, which may include:
  • Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA), and new drug applications (NDA)
  • Deliverables for meetings with Regulatory Agencies (meeting requests, briefing books, slides, minutes)
  • Clinical study protocols and protocol amendments
  • Clinical study reports (CSR)
  • Investigator brochures (IB)
  • Responses to requests from regulatory agencies and ethics committees
  • Informed consent and assent forms
  • Lay summaries of clinical trial results
  • Clinical evaluation plans (CEP) and clinical evaluation reports (CER)
  • Pediatric investigational plans (PIP)
  • Orphan Drug applications
  • Breakthrough Therapy Designation requests

• Leads the sharing of better practices to optimize the way we work and increase awareness of medical writing within the project area:
  • Shares project specific and general medical writing practices with other Medical Writers and contributes to process improvements within the project area and globally
  • Promotes awareness of medical writing practices and ideas and sets medical writing standards within the project area
  • Routinely presents medical writing information to management
  • Actively participates in relevant meetings, training sessions, and seminars in the department and relevant project(s)
• General Tasks:
  • Provides leadership in local and global project teams, facilitates collaboration, and drives decision making
  • Leads meetings and drives decisions concerning project/trial-specific medical writing issues. Independently resolves document content issues and questions arising during the writing process
  • Assesses the quality of documents; provides findings and clear feedback to document authors
  • Interprets and accurately presents clinical and statistical data in a clear, concise format
  • Can identify and resolve complex problems related to Medical Writing projects, processes, or tasks, with management support as needed
  • Provides mentorship, guidance, or training to less-experienced Medical Writers
  • Maintains up-to-date knowledge and understanding of the laws, regulations, industry standards, and company policies/procedures relevant to Medical Writing. Remains current with respect to the literature on Novo Nordisk therapeutic areas and competitor products

Physical Requirements

Less than 10% overnight travel. May include travel outside the US.

Qualifications

• Education Level:
  • Minimum of BS/BA, preferably in a health-related or scientific discipline
• Experience Level:
  • Requires 9+ years of relevant experience. Minimum of 8 years clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment. Equivalent experience with advanced degree or in other settings will be considered

• Specific or technical job skills:
  • Demonstrated understanding of clinical research, the drug/device development process, and applicable regulatory guidelines
  • Demonstrated understanding of statistical approaches in clinical study design and analysis
  • Extensive experience contributing to drug applications with the FDA and EMA. Experience with applications in Japan and China a plus
  • Able to collaborate with individuals across different time zones and ensure efficient communication and coordination with team members worldwide. This role requires adaptability and strong organizational skills to effectively manage projects and meet deadlines across various geographical locations
  • Exceptional written and oral communication skills, with mastery of English grammar and punctuation
• Managerial experience:
  • None required. Experience mentoring and developing other medical writers is a plus

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.

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