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Department Clinical Reporting Unit
Are you an experienced Medical Writing specialist with a strong background in regulatory medical writing Do you have a passion for clear and concise communication of clinical data We are looking for a Medical writing Specialist to join our Clinical Reporting team at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the pharmaceutical industry read on and apply today for a lifechanging career.
About The Department
The Clinical Reporting unit in Global Business Service has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community in a short span of 67 years since its inception in 2011. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writers Disclosure Medical Writers Publishers and Document Controllers with master/PhD in life sciences pharmacology medicine etc. The team is full of commitment passion skills and talent with broad knowledge of different therapeutic areas and regulatory requirements for submissions. The team has an average experience of 78 years in writing and reviewing regulatory documents and publications. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. Apart from writing and publishing regulatory documents the team is also responsible for the distribution of documents (CONNECT portal) and largely contributes to NNs regulatory commitments by being involved in public disclosure activities.
The position
As a Medical Writing Specialist you will be responsible for performing medical writing tasks of high complexity and acting as a project manager. Your role will involve planning developing and overseeing regulatory documents across all phases of clinical development. This includes but is not limited to the preparation of Protocols Clinical Trial Reports (CTRs) Noninterventional study reports (NSRs) Meeting packages and briefing books Investigator Brochure (IB) Regulatory response documents (QA) Clinical summaries and Clinical overviews. In this role you will be expected to set direction drive discussions ensure decisions are made and influence and implement project strategy.
As a Medical Writing Specialist at Novo Nordisk you will have the responsibilities to:
Qualification
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Remote Work :
No
Full Time