Medical Writers at all levels with medical device experience
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Søborg
We currently have two job openings focused on medical devices, as we are expanding our team to accommodate our involvement in new projects and tasks. This is a fantastic opportunity to combine your scientific knowledge and writing skills in an important role within Novo Nordisk. The company has been a world leader in delivering therapeutics to patients with serious chronic diseases for 100 years. You will have the opportunity to work as a strategic partner in a dynamic environment within Development to bring ground-breaking treatments and their corresponding delivery solutions to patients worldwide through the planning and preparation of a broad range of regulatory documents. Apply now for this exciting job opportunity!
About the department
You will join us in Clinical Reporting, which includes the medical writing function at Novo Nordisk. We are part of Development and anchored in the Submission & Life Cycle Management area. Development is responsible for managing clinical drug and medical device development and regulatory submissions worldwide, from early development phases to market authorisation. For medical devices, the main focus is on regulatory submissions for CE-marking in compliance with the EU MDR 2017/715 yet may also be towards other main markets. In Clinical Reporting we are approximately 70 Medical Writers and Clinical Publishers, and we pride ourselves on diversity and professionalism.
The positions The first role is a Medical Writer or Senior Medical Writer position, depending on your former experience. Your main task is to communicate clinical data in a clear and concise manner. To be successful, you must be able to take charge of document preparation, coordinate activities and work in cross-disciplinary teams. The clinical documents you prepare are intended for regulatory authorities and comprise of clinical evaluation plans, clinical evaluation reports, Q&A interactions with regulatory authorities. You may also prepare related documents such as device clinical trial protocols, device investigator’s brochures, summary documents and other materials relating to interpretation and documentation of clinical data. We cover all medical device development projects within Novo Nordisk’s product portfolio. As such, we are globally oriented, and the Medical Writer will work in close collaboration with colleagues in other skill areas in Denmark and abroad. The other role is a Medical Writing Specialist position to support an interesting business development project. You will be expected to take on the same responsibilities as outlined for the Medical Writer role above. In addition, in this position you will need great stakeholder management and negotiation abilities. You will act as project Medical Writer which include support to peer Medical Writers, keeping overview of incoming tasks and track of progress across deliverables to ensure that deadlines are met.
Qualifications
An ideal candidate, should demonstrate the following: University degree within natural or clinical/medical sciences (M.Sc., M.Sc. Pharm, or equivalent), preferably with a Ph.D. Proficiency in writing and communicating in English at an accomplished professional level. A genuine interest in scientific communication and the ability to convey complex information clearly and concisely. Experience with preparing clinical evaluations and trial-related documentation for medical devices, software as medical devices, or drug-device combination products will be regarded as an asset, so will knowledge of EU-MDR requirements. On a personal level, you can work both independently and as part of a cross-functional team in a dynamic environment with tight deadlines. Proficient in planning, coordinating, and managing stakeholders to drive the writing process and facilitate decision-making, you exhibit a thorough and structured approach while also being pragmatic and unafraid of challenging the status quo. Your positive can-do attitude and sense of humour contribute to a productive and enjoyable work environment.
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. Your place of work will be in Søborg, Denmark.
Contact
For further information please contact Team Lead, Stine Ostenfeldt Rasmussen (+45 3079 2590) or Director, Annerose Berndt (+45 3079 2041).
Deadline
25 November 2023. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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 department
You will join us in Clinical Reporting, which includes the medical writing function at Novo Nordisk. We are part of Development and anchored in the Submission & Life Cycle Management area. Development is responsible for managing clinical drug and medical device development and regulatory submissions worldwide, from early development phases to market authorisation. For medical devices, the main focus is on regulatory submissions for CE-marking in compliance with the EU MDR 2017/715 yet may also be towards other main markets. In Clinical Reporting we are approximately 70 Medical Writers and Clinical Publishers, and we pride ourselves on diversity and professionalism.
The positions The first role is a Medical Writer or Senior Medical Writer position, depending on your former experience. Your main task is to communicate clinical data in a clear and concise manner. To be successful, you must be able to take charge of document preparation, coordinate activities and work in cross-disciplinary teams. The clinical documents you prepare are intended for regulatory authorities and comprise of clinical evaluation plans, clinical evaluation reports, Q&A interactions with regulatory authorities. You may also prepare related documents such as device clinical trial protocols, device investigator’s brochures, summary documents and other materials relating to interpretation and documentation of clinical data. We cover all medical device development projects within Novo Nordisk’s product portfolio. As such, we are globally oriented, and the Medical Writer will work in close collaboration with colleagues in other skill areas in Denmark and abroad. The other role is a Medical Writing Specialist position to support an interesting business development project. You will be expected to take on the same responsibilities as outlined for the Medical Writer role above. In addition, in this position you will need great stakeholder management and negotiation abilities. You will act as project Medical Writer which include support to peer Medical Writers, keeping overview of incoming tasks and track of progress across deliverables to ensure that deadlines are met.
Qualifications
An ideal candidate, should demonstrate the following:
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. Your place of work will be in Søborg, Denmark.
Contact
For further information please contact Team Lead, Stine Ostenfeldt Rasmussen (+45 3079 2590) or Director, Annerose Berndt (+45 3079 2041).
Deadline
25 November 2023. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.
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 9.11.2023, 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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