Experienced Medical Writer, Regulatory, Quality & Clinical Reporting, Søborg, Denmark (Denmark, Søborg)

Jobbeskrivelse

Placering
Søborg, Denmark

Jobkategori
Clinical Development

This role is an exciting opportunity to blend scientific expertise with impactful communication, helping shape innovative healthcare solutions at a globally leading company like Novo Nordisk!

Your new the role
This is a permanent position in Medical Writing. In this role, your main responsibility will be to drive the preparation of complex clinical documents and act as a project manager. More specifically, you are expected to lead tasks such as:

• Plan, develop, and oversee high-quality regulatory and clinical documents in line with business needs and timelines.
• Prepare key documents such as study protocols, informed consent forms, investigator’s brochures, clinical summaries, and paediatric plans .
• Develop briefing packages and responses to health authority questions .
• Represent Clinical Reporting in cross-functional project teams , providing guidance on document planning, requirements, and optimal data presentation.
• Collaborate across Medical & Science, Regulatory Affairs, Clinical Operations, Biostatistics, and Pharmacovigilance to ensure accurate, complete, and scientifically sound reporting.

We are globally oriented and you will work in close collaboration with colleagues in cross-functional teams in both Denmark and abroad. The position is office-based in Søborg, Denmark.

Your new department
You will join us in Clinical Reporting, the medical writing function at Novo, currently comprising around 200+ medical writers worldwide. We are part of Novo 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.

Your skills and qualifications
To succeed in this role, we expect you to 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.
• A track record of driving complex tasks from start to end, navigating a multidisciplinary stakeholders’ landscape.
• A high level of expertise in communicating scientific information, with the ability to tailor such information to meet diverse objectives.
• The ability to improve processes and to promote the sharing of better practices.
• A good understanding of clinical development, regulatory processes and 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 are a collaborative team player, that effectively manage various stakeholders and can reach consensus. You are detail-oriented 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.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination, and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect, and a willingness to go beyond what we know delivers extraordinary results.

What We Offer

At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary: For this role, the Annual Base Salary ranges from 651,000.00 to 956,900.00 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

You do not need to attach a cover letter; please include a few sentences about your motivation in your CV. Kindly refrain from adding a photo to your CV to ensure a fair recruitment process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.