Director of Medical Writing

R&D Partners; København; Hybrid; DKK 1,000,000 - 1,400,000; Full time

Job summary

R&D Partners is seeking a Director of Medical Writing to lead clinical and regulatory writing for a key clinical‑stage asset. This hands‑on role translates complex clinical and statistical data into clear, regulatory‑readable documents and collaborates with cross‑functional teams to align content with program strategy.

Based in Denmark with a hybrid work model in Copenhagen, the position requires a Bachelor’s or higher in science, 10+ years of medical writing experience, and strong knowledge of

Qualifications

• 10+ years of hands-on medical writing in biotech/pharma/CRO environments.
• Bachelor's degree or higher in a scientific discipline.
• Experience authoring clinical and regulatory documents across drug development stages.
• Strong knowledge of ICH E3, E6 and FDA/EMA requirements.
• Proven ability to interpret clinical trial data and statistical outputs.
• Excellent written English communication and cross-functional collaboration.
• Ability to manage competing priorities and deadlines independently.

Responsibilities

• Lead medical writing for a clinical‑stage asset from strategy to finalization.
• Develop Clinical Study Protocols, Study Reports, Investigator Brochures and submission documents.
• Contribute to regulatory and safety documents, including briefing documents and DSURs.
• Translate complex data into clear, scientifically accurate narratives.
• Partner with Clinical Development, Regulatory Affairs, Biostatistics, Safety and teams to align content with strategy.
• Drive cross‑functional document reviews and resolve comments with alignment.
• Apply regulatory requirements and guidance (ICH E3, E6, FDA/EMA).
• Develop writing plans and timelines to meet development and submission schedules.
• Maintain document quality, version control, and adapt to evolving priorities.
• Identify risks and provide clear recommendations to the program team.
• Coordinate with internal teams and external vendors on public disclosure activities.

Skills

Medical writing

Clinical data interpretation

English writing

Cross-functional collaboration

Regulatory knowledge

Prioritization

ICH E3/E6 knowledge

Education

Bachelor's degree in science

MS/PhD preferred

Job description

Ready to lead the clinical narrative behind a breakthrough therapy and shape the documents that drive regulatory decisions worldwide?

R&D Partners is seeking a Director of Medical Writing to lead clinical and regulatory writing for a key clinical-stage compound. This hands‑on role involves turning complex clinical and scientific data into clear, accurate documents that support regulatory decision‑making. You will collaborate with cross‑functional teams to align content with program strategy and ensure high‑quality outputs under demanding timelines.

This is a hybrid role based in Denmark.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Lead medical writing for a clinical‑stage compound, from strategy and planning to finalization.
• Develop clinical documents such as Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, and submission documents.
• Contribute to regulatory and safety documents, including briefing documents, regulatory responses, and DSURs.
• Translate complex clinical and statistical data into clear, scientifically accurate narratives.
• Partner with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and other teams to align document content with program strategy.
• Drive cross‑functional document reviews, resolve comments constructively, and build alignment.
• Apply regulatory requirements and guidance, including ICH E3, ICH E6, and FDA/EMA expectations.
• Build writing plans and frameworks to meet development and submission timelines.
• Maintain document quality, consistency, and version control while adapting to evolving priorities.
• Identify risks early, propose solutions, and provide clear recommendations to the program team.
• Collaborate with internal teams and external vendors to manage public disclosure activities in compliance with transparency requirements.

Key Skills and Requirements:

Essential:

• Bachelor's degree or higher in a scientific discipline.
• Minimum of 10 years of hands‑on medical writing experience in biotechnology, pharmaceutical, or CRO environments.
• Proven expertise in authoring clinical and regulatory documents across drug development stages.
• Strong knowledge of ICH E3, ICH E6, and relevant FDA/EMA requirements.
• Scientific fluency with the ability to interpret clinical trial data and statistical outputs accurately.
• Exceptional written English skills with the ability to communicate complex science clearly and precisely.
• Strong cross‑functional communication skills and experience aligning multiple expert reviewers.
• Ability to manage competing priorities and deadlines independently while maintaining high‑quality standards.

Preferred:

• Advanced scientific degree (MS, PhD, or PharmD).
• Medical writing certification or relevant regulatory affairs training.

What to Expect

This role offers the opportunity to shape medical writing processes and frameworks in a growing biotech environment. The organization operates across Europe and the US, requiring adaptability to evolving priorities as clinical data and development plans progress. Success in this role demands ownership, pragmatism, and a collaborative mindset to navigate ambiguity and drive progress.

Why Join?

• Lead medical writing strategy and execution for a key clinical‑stage asset.
• High visibility across Clinical Development, Regulatory Affairs, and senior leadership.
• Opportunity to shape processes in a dynamic and growing biotech company.
• Contribute to the development of innovative therapies addressing significant unmet medical needs.
• Hybrid role based in Copenhagen, fostering close collaboration with scientific and cross‑functional teams.

Compensation:

- only to be included for the above highlighted US locations!

Salary:

- only to be included for above highlighted EU countries.

For more information, please contact Bobby Burke.

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