Clinical Writing Expert | Novo Nordisk Development
1 day ago
We are seeking an experienced Clinical Writing Expert to join our team in Clinical Reporting at Novo Nordisk A/S. As a key member of our team, you will be responsible for driving the preparation of complex clinical documents and serving as a project manager.
Main Responsibilities:- Lead tasks such as planning, development, and oversight of regulatory documents, including study protocols, informed consent forms, investigator's brochures, PIPs, clinical summaries, paediatric plans, briefing packages, and responses to health agency questions according to business needs.
- Represent Clinical Reporting on cross-functional project teams and provide guidance on regulatory document requirements and optimal data presentation.
- Collaborate with other job functions across Development, ensuring all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation - all in accordance with project timelines.
To succeed in this role, we expect you to have a Master's degree within natural sciences (M.Sc., M.Sc. Pharm. or equivalent), preferably supplemented with a PhD and ≥5 years of relevant experience as a medical writer in the pharmaceutical industry.
You should have a track-record of driving your own complex tasks from start to end, navigating multiple stakeholders, and communicating scientific information effectively.
An expert understanding of clinical development, regulatory processes & requirements, and clinical documents is essential.
Full proficiency in spoken and written English is required.
About Our TeamClinical Reporting covers all clinical drug development projects across therapy areas. Our main focus is to use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials, and our main task is to communicate clinical data in a clear and concise manner.
What We OfferAs a Clinical Writing Expert at Novo Nordisk, you can expect a competitive salary: $120,000 - $160,000 per year, depending on experience. Additionally, we offer a modern work environment with flexible working hours, free-flowing coffee and tea, fruit, on-site canteens, take-out dinner options, electric car-charging stations, health insurance, social clubs, and much more.
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