Senior Medical Writer
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Søborg
Are you an experienced Medical Writer looking to grow your career? Do you want to bring scientific communication and project management skills to kick-start your medical writing career in a global healthcare company? If yes, we would love to hear from you! The position This is a permanent position as a Senior Medical Writer, your main responsibility is to drive the preparation of complex clinical documents and act as a project manager. More specifically, you are expected to lead tasks such as: Planning, development, and oversight of regulatory documents, including study protocols, informed consent forms, investigator’s brochures, clinical summaries, paediatric plans, briefing packages, and responses to health agency questions according to business needs. Representing Clinical Reporting on cross-functional project teams and providing guidance on regulatory document requirements and optimal data presentation. Working collaboratively with other job functions across Development (notably Biostatistics, Pharmacovigilance, Medical & Science, Regulatory Affairs, Clinical Operations, and others), ensuring all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation - all in accordance with project timelines. In addition to your own medical writing tasks, you will work to develop and improve our internal processes and promote the sharing of better practices across areas. At senior level, you will mentor and train other medical writers and be responsible for the document quality in your team as well as for the documents you are authoring. We are globally oriented, and as a Senior Medical Writer, you will work in close collaboration with colleagues in cross-functional teams in both Denmark and abroad. The position is office-based in Søborg, Denmark. Qualifications To succeed in this role, we expect you to have: A master’s degree within natural sciences (MSc., MSc. Pharm. or equivalent), preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry. A track record of driving your own complex tasks from start to end, navigating many different stakeholders, and are an expert in communicating scientific information. The ability to improve processes and to promote the sharing of better practices. An expert understanding of clinical development, regulatory processes & requirements, and clinical documents. Full proficiency in spoken and written English. On a personal level, you are a clear communicator who adapts easily to a changing environment with tight deadlines. You are strategic, proactive, and have excellent planning and coordination skills with the competency to drive and engage teams. You effectively manage various stakeholders and can reach consensus. You are detail-oriented and structured, while being pragmatic and not afraid of challenging the status quo. Furthermore, you have a positive can-do attitude and a good sense of humour. About the department You will join us in Clinical Reporting, the medical writing function at Novo Nordisk – currently comprising around 200 medical writers worldwide. We are part of Novo Nordisk Development and anchored together with Regulatory and Quality functional areas. Development is responsible for managing clinical drug development and submissions to health authorities worldwide, from the early development phases to market authorisation. Our supportive culture drives business transformation, and we value continuous learning, being bold, and striving for simplicity. Clinical 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. Working at Novo Nordisk Novo Nordisk is driving change to defeat diabetes and other serious chronic conditions. We use our skills, dedication, and ambition to help change lives for the better for patients around the world. We strive for excellence and for always keeping a positive and collaborative atmosphere in our daily work. We offer a modern work environment with flexible working, free-flow of coffee and tea, fruit, on-site canteens, take-out dinner options, electric car-charging stations, health insurance, social clubs, and much more. Contact For further information, please contact Ann Olling (+45 3079 7294). Deadline 08 December 2024. We will review applications on an ongoing basis, so we encourage you to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 4.12.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Søborg
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