Principal Medical Writer
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Søborg
Are you a highly experienced medical writer looking for possibilities to grow your career further and apply your diverse medical writer toolbox within Novo Nordisk? If yes, then we would love to hear from you. Apply now! About the department You will join us in Clinical Reporting, which is the medical writing function at Novo Nordisk and anchored in the Submission & Life Cycle Management area. We are part of Development, which is responsible for managing clinical drug development and submissions to health authorities worldwide from the early development phases to market authorisation. In Clinical Reporting, we are approximately 100 medical writers globally and pride ourselves on diversity, engagement and professionalism. Clinical Reporting covers all clinical drug development projects within Novo Nordisk’s different therapy areas and our main task is to communicate clinical data in a clear and concise manner. The clinical documents are mainly intended for regulatory authorities and comprise protocol documents, clinical study reports, investigator’s brochures, summary documents and other documents covering interpretation of clinical data.
The position In this role you will, via strategic planning and preparation of a broad range of regulatory documents, act as a key partner in a dynamic environment thereby bringing ground-breaking treatments to patients worldwide. As a principal medical writer, you will be guiding and setting the directions for colleagues as well as close stakeholders within your project. The position will be anchored within one of the therapy areas in Novo Nordisk and you will have a key role as project medical writer in one or more of the ongoing projects where you are expected to deliver expert advice to the project team. You will plan and coordinate activities in a cross-disciplinary setting and collaborate with many internal stakeholders in our global organisation. Your main tasks will include: Planning, developing, and having an oversight of clinical/regulatory documents, including study protocols, informed consent forms, clinical study reports, investigator’s brochures, NDA submissions and clinical summaries, paediatric plans, briefing packages, and responses to health agency questions according to business needs. Being familiar with and implement the new EU Clinical Trial Regulation in relevant documents Contributing to drive optimised processes ensuring that we continue being at the forefront of clinical reporting Collaborating closely with other job functions across Development (notably Biostatistics, Medical & Science, Regulatory Affairs, Clinical Operations, and Pharmacovigilance), ensuring all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation and in accordance with project timelines In addition, we expect you to be proactive in assessing the need for using new methods, technologies and digitalisation based on your broad and deep experience within medical writing. Qualifications In order to be successful in this position, you need to have the following: A PhD or a Master´s degree in science or equivalent Extensive and broad experience with drug development in the pharmaceutical industry; including medical writing (at least 8 years of documented experience) Experience with a broad range of different medical writing tasks Strong experience with regulatory requirements within drug and device development Excellent communication, collaboration and stakeholder management skills A creative mindset that fosters process innovation and digitalisation As a person, you thrive in a fast-paced work environment and bring a can-do-attitude. You are a skilled communicator, who can collaborate as a strategic business partner at any organisational level. You are proactive and have excellent planning and coordination skills with the competency to drive and engage teams. You will be an active contributor to the established teamwork culture, supporting your colleagues to ensure success of the entire team. Working at Novo Nordisk Novo Nordisk is driving change to defeat diabetes and other serious chronic conditions including rare diseases. We use our skills, dedication and ambition to help changing 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. Contact For further information, please reach out to Betina Thuesen (+45 3079 3894) or Casper Hempel (+45 3079 8940). We will review applications on an ongoing basis, so please do not hesitate to apply. Deadline 12 February 2023. 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.
The position In this role you will, via strategic planning and preparation of a broad range of regulatory documents, act as a key partner in a dynamic environment thereby bringing ground-breaking treatments to patients worldwide. As a principal medical writer, you will be guiding and setting the directions for colleagues as well as close stakeholders within your project. The position will be anchored within one of the therapy areas in Novo Nordisk and you will have a key role as project medical writer in one or more of the ongoing projects where you are expected to deliver expert advice to the project team. You will plan and coordinate activities in a cross-disciplinary setting and collaborate with many internal stakeholders in our global organisation. Your main tasks will include:
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 26.1.2023, 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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