Medical Writing Specialist/experienced medical writer
3 days ago
Are you an experienced Medical Writer looking to grow your career? If yes, then we would love to hear from you.
The positionAs Medical Writing Specialist, your main responsibility is to drive the preparation of complex clinical documents and act as 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, PIPs, 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), 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 develop and improve our internal processes, and promote the sharing of better practices across areas. As a specialist, you will mentor and train other medical writers and be responsible for the document quality in your team, as well as your own documents.
QualificationsTo 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.
- 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 are able to reach consensus. You are thorough 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 departmentYou will join us in Clinical Reporting. The medical writing function at Novo Nordisk currently employs approximately 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 NordiskNovo 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.
ContactFor further information please contact Grith Møller (+45 3077 6487)
Deadline06 January 2025.
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.
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.
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