Director of Medical Writing — Clinical Development Strategy

Hemab Therapeutics; København; Hybrid; DKK 1,800,000 - 2,400,000; Full time

Job summary

Hemab Therapeutics in Copenhagen and Cambridge is seeking a Director, Medical Writing to own the clinical and regulatory writing for one of our lead compounds, ensuring clear, regulatory-ready documents that connect science, data and development strategy.

You will lead writing from strategy through drafting, review and finalization, collaborating with clinical, regulatory, biostatistics and safety teams to meet demanding timelines.

Qualifications

• Bachelor’s degree in science with 10+ years of hands-on medical writing experience in biotech/pharma/CRO settings.
• Experience authoring clinical and regulatory documents across drug development.
• Strong working knowledge of ICH E3, ICH E6 and FDA/EMA requirements.
• Excellent written English with ability to present complex science clearly and concisely.
• Proven cross-functional collaboration and ability to bring multiple reviewers into alignment.
• Ability to own competing documents and deadlines independently while maintaining quality.

Responsibilities

• Own medical writing for one of our leading compounds from strategy through drafting, review and finalization.
• Lead development of clinical documents (protocols, CSRs, IBs, submission documents) as appropriate to program stage.
• Contribute to clinical content of regulatory and safety documents (briefing documents, responses, DSURs).
• Translate complex clinical and statistical data into clear, scientifically accurate narratives for regulators.
• Collaborate with clinical development, regulatory, biostatistics, safety and other teams to align content with program strategy.
• Drive cross-functional document reviews, resolve comments and maintain scientific accuracy and timelines.
• Apply regulatory requirements (ICH E3/ICH E6, FDA/EMA) and maintain writing plans to keep documents moving.
• Ensure document quality, consistency and version control amid evolving data and priorities.

Skills

Medical writing leadership

Regulatory writing

Cross-functional collaboration

ICH E3/E6 knowledge

Regulatory affairs knowledge

Excellent written English

Education

Bachelor's degree in science

MS/PhD/PharmD preferred

Job description

Hemab Therapeutics in Copenhagen and Cambridge is seeking a Director, Medical Writing to own the clinical and regulatory writing for one of our lead compounds, ensuring clear, regulatory-ready documents that connect science, data and development strategy.

You will lead writing from strategy through drafting, review and finalization, collaborating with clinical, regulatory, biostatistics and safety teams to meet demanding timelines.