About the Department
Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure. Are you ready to make a difference?
The Position
The Associate Director is an expert in Medical Writing and performs work independently with minimal-to-no supervision. The Associate Director 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 Associate Director will provide high level strategic input into development plans, study designs, and regulatory submissions.
Relationships
The Associate Director, Medical Writing (ADMW) reports to a Director of Medical Writing. The Associate Director is expected to develop and maintain a strong network of internal relationships with global and local cross-functional study teams. The Associate Director should be seen as a key resource for Medical Writing expertise and provides active leadership on local and global project teams, as needed. The Associate Direct will provide mentoring and direction to less-experienced medical writers, as needed. The Associate Director may supervise other members of the Medical Writing team.
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
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.