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Associate Director : Medical Writing
Location:
Princeton, NJ
Description:
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 and 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:stylelist:style:type:circle::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:stylelist:style:type:circle::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):Inves
Posted:
May 16 on Tip Top Job
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More About this Listing: Associate Director : Medical Writing
Associate Director : Medical Writing is a Executive Associate Director Job located in Princeton NJ. Find other listings like Associate Director : Medical Writing by searching Oodle for Executive Associate Director Jobs.
Associate Director : Medical Writing is a Executive Associate Director Job located in Princeton NJ. Find other listings like Associate Director : Medical Writing by searching Oodle for Executive Associate Director Jobs.