Director, Medical Writing & Regulatory Strategy

Hemab Therapeutics; København; On-site; DKK 120,000 - 180,000; Full time

Job summary

Hemab Therapeutics is seeking a Director, Medical Writing to own the clinical and regulatory writing for one of our development compounds. You will shape documents, collaborate with physicians, scientists, biostatisticians and regulatory colleagues to produce high‑quality submissions on ambitious timelines.

You will write and drive protocols, study reports, IBs and regulatory responses, translating complex clinical data into clear narratives for regulators while ensuring alignment with ICH E3/E6

Qualifications

• Bachelor’s degree in a scientific discipline; 10+ years hands-on medical writing experience in biotechnology, pharmaceutical or CRO clinical research environments.
• Significant experience authoring clinical and regulatory documents across drug development.
• Strong working knowledge of ICH E3, ICH E6 and relevant FDA and EMA requirements.
• Scientific fluency and the ability to interpret clinical trial data and statistical outputs accurately.
• Excellent written English, with the ability to make complex science clear, structured and precise.
• Strong cross-functional communication skills and experience bringing multiple expert reviewers to alignment.
• Ability to own competing documents and deadlines independently while maintaining quality.

Responsibilities

• Own medical writing for one leading compound, from document strategy and planning through drafting, review and finalization.
• Lead development of clinical documents, including clinical study protocols, clinical study reports, Investigator’s Brochures, and clinical submission documents appropriate to the program’s stage.
• Contribute to clinical content of regulatory and safety documents, such as briefing documents, regulatory responses, and DSURs.
• Translate complex clinical and statistical data into clear, scientifically accurate narratives for regulatory reviewers.
• Partner closely with clinical development, regulatory, biostatistics, safety, and other scientific colleagues to align document content with the program strategy.
• Drive cross‑functional document reviews, resolve comments constructively and build alignment without compromising scientific accuracy.
• Apply relevant regulatory requirements and guidance, including ICH E3, ICH E6 and applicable FDA and EMA expectations.
• Build writing plans and practical frameworks that keep interdependent documents moving against development and submission timelines.
• Maintain document quality, consistency and version control while adapting quickly as data, priorities and timelines evolve.
• Identify writing or documentation risks early, take ownership of solutions and give the program team a clear view of what is needed next.
• Collaborate with internal cross‑functional teams and external vendors to manage public disclosure activities in compliance with transparency rules.

Skills

Medical writing

Clinical regulatory writing

ICH E3/E6

FDA/EMA requirements

English proficiency

Cross-functional collaboration

Independent ownership

Education

Bachelor’s degree in science

MS/PhD preferred

Job description

Hemab Therapeutics is seeking a Director, Medical Writing to own the clinical and regulatory writing for one of our development compounds. You will shape documents, collaborate with physicians, scientists, biostatisticians and regulatory colleagues to produce high‑quality submissions on ambitious timelines.

You will write and drive protocols, study reports, IBs and regulatory responses, translating complex clinical data into clear narratives for regulators while ensuring alignment with ICH E3/E6