Address
Form of workAbout the Department
Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, 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. Our greater Boston R&D 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.
The Position
The Medical Writer works closely with cross-functional project teams to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Medical Writer performs work independently under the supervision of more experienced personnel.
Relationships
The Medical Writer (MW) reports to an Associate Director of Medical Writing.
The MW is expected to develop and maintain a network of internal relationships with global and local cross-functional study teams, including personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.
Essential Functions
- Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which may include:
- Clinical study protocols and protocol amendments
- Clinical study reports (CSR)
- Investigator brochures (IB)
- 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
Physical Requirements
Approximately 10% overnight travel. May include travel outside the US.
Qualifications
- Education Level:
- Minimum of BS/BA, preferably in a health-related or scientific discipline
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.
