Senior Medical Writer

5+ years

Not Disclosed

Remote, USA

10 Nov. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Medical Writer – Medical Devices

Location: Søborg, Denmark
Company: Novo Nordisk

Are you passionate about scientific communication and writing?

If you have experience in medical writing and a strong interest in medical devices, Novo Nordisk invites you to apply for the position of Senior Medical Writer. This is a fantastic opportunity to work for a world leader in delivering therapeutics to patients with chronic diseases and contribute to the development of cutting-edge medical devices that improve lives globally.

The Position:

As a Senior Medical Writer at Novo Nordisk, you will play a critical role in communicating clinical data in a clear and concise manner to regulatory authorities and other key stakeholders. You will be involved in the preparation and coordination of clinical documents such as clinical evaluation plans, clinical evaluation reports, post-market clinical follow-up plans, device clinical investigation protocols, investigator’s brochures, and much more. Your work will primarily focus on medical devices, including drug-device combination products, in-vitro diagnostic products, and software as medical devices.

Key responsibilities will include:

Stakeholder Management: Lead and drive the writing process, facilitating decision-making in a cross-functional and dynamic environment with tight deadlines.
Document Preparation and Coordination: Prepare essential clinical documents for regulatory submissions, ensuring compliance with EU-MDR and other relevant regulations.
Mentorship and Training: Act as a senior writer, mentoring and training other medical writers, ensuring a high standard of work across the team.
Process Improvement: Contribute to the development of internal processes, promoting best practices and continuous improvement within the department.
Cross-functional Collaboration: Work closely with colleagues in Denmark and abroad to ensure the timely delivery of high-quality documentation.

Qualifications:

To succeed in this role, you should have:

A university degree in natural or clinical/medical sciences (M.Sc., M.Sc. Pharm, or equivalent). A Ph.D. is preferred but not required.
Experience in preparing clinical evaluations and trial-related documentation for medical devices, software as medical devices, drug-device combination products, or in-vitro diagnostic products.
Knowledge of EU-MDR requirements is essential; experience with other major market requirements is an asset.
Strong written and spoken English communication skills, with the ability to convey complex scientific concepts clearly and concisely.
Ability to work independently as well as part of a cross-functional team, managing multiple tasks and deadlines in a dynamic environment.

About the Department:

You will join Clinical Reporting, which is part of Development within Novo Nordisk. This function is integral to the company’s regulatory, quality, and clinical reporting activities. The team is responsible for managing clinical drug and medical device development, regulatory submissions, and ensuring market authorization globally. The focus for medical devices includes regulatory submissions for CE-marking in compliance with the EU MDR 2017/745, with support also for other international markets.

Working at Novo Nordisk:

Novo Nordisk is at the forefront of developing life-changing treatments for chronic conditions such as diabetes. We foster a collaborative and positive work environment, striving for excellence and embracing innovation. We offer flexible working arrangements, including the possibility to work from home, while your primary location will be in Søborg, Denmark.

Contact:

For more information, please contact Stine Ostenfeldt Rasmussen, Manager, at +45 3079 2590.

Deadline:

The application deadline is 24 November 2024. Please include a brief statement in your CV about why you are applying for the position. Note that a cover letter is not required, and please refrain from adding a photo to your CV for an efficient and fair recruitment process.

Equal Opportunity Employer:

At Novo Nordisk, we are committed to creating an inclusive culture that celebrates diversity and offers equal opportunities to all job applicants. We value diverse perspectives, backgrounds, and experiences and believe that our differences make us stronger. Together, we’re life changing.

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Senior Medical Writer

Job Description

Job Title: Senior Medical Writer – Medical Devices

Are you passionate about scientific communication and writing?

The Position:

Qualifications:

About the Department:

Working at Novo Nordisk:

Contact:

Deadline:

Equal Opportunity Employer:

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