Novo Nordisk
Medical Writers - all levels
This job is now closed
Job Description
- Req#: 285230
- planning, development and oversight of clinical/regulatory documents, including study protocols, informed consent forms, clinical study reports (all phases), 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.
- You 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.
- You have 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.
- You can demonstrate your ability to improve processes and to promote the sharing of better practices. You have expert understanding of clinical development, regulatory processes & requirements and clinical documents.
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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 positions are office-based in Denmark, with flexibility for part-time homeworking. Our colleagues and stakeholders are diverse and many are based internationally.
Relocation support may be considered for candidates with more than 5 years’ experience of regulatory medical writing.
The position
As a Medical Writer, 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:
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 and specialist 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 your are authoring.
QualificationsYou 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 department
You will join us in Clinical Reporting, the medical writing function at Novo Nordisk – currently comprising around 150 medical writers worldwide. We are part of Novo Nordisk Development and anchored in the Submission & Life Cycle Management area. 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.
Medical Writing at Novo Nordisk is expanding. As we grow into new therapy areas and new indications, we are delighted to be offering positions at a range of seniority levels to join our global team. This is a fantastic opportunity to combine your scientific knowledge and writing skills in crucial role within Novo Nordisk.
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 Annerose Berndt (+45 3079 2041) or Ann Olling (+45 3079 7294).
Deadline
06 September 2023We 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.
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.
About the company
Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, with production facilities in eight countries, and affiliates or offices in 5 countries.
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