Director, Medical Writing

Hemab Therapeutics; København; Presencial; DKK 120 000 - 180 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Medical writing

Clinical regulatory writing

ICH E3/E6

FDA/EMA requirements

English proficiency

Cross-functional collaboration

Independent ownership

Formação académica

Bachelor’s degree in science

MS/PhD preferred

Descrição da oferta de emprego

Reporting to: Snr Director, Medical Writing

Hemab is building preventative treatments for serious, underserved bleeding disorders. These therapies are designed to work with the body's own biology and stop bleeds before they start, instead of treating them after they happen. We're patient-first, science-led and clinical-stage, with a pipeline that takes different scientific approaches to different patient needs.

We went public via our 2026 IPO, and we're scaling across two homes: Cambridge, MA, USA, and Copenhagen, Denmark.

The role

As Director, Medical Writing, you will be dedicated to one of our compounds under clinical development, taking ownership of the clinical and regulatory writing that helps move this compound through development. You will turn complex clinical and scientific evidence into clear, accurate documents that regulators can act on - connecting the science, data and development strategy into one coherent story.

This is a hands‑on role. You will write, shape and drive documents yourself while bringing physicians, scientists, biostatisticians and regulatory colleagues together around high‑quality outputs and demanding timelines.

What You'll Do At Hemab

• Own medical writing for one of our leading compounds, 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.

What You'll Bring to Hemab

• Bachelor’s degree or higher in a scientific discipline, with at least 10 years of 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.

Nice to have

• Advanced scientific degree such as an MS, PhD or PharmD.
• Medical writing certification or relevant regulatory affairs training.

What to expect, honestly

Hemab is still building a lot of its own structure. You'll create some of the writing frameworks you need rather than inherit a finished system. We work across Copenhagen and Cambridge and priorities can move quickly as clinical data and development plans change.

You'll need to solve problems when you reach the first wall rather than pass them on. That means taking ownership, asking for help when you need it, working without ego and being comfortable making progress when every answer isn't available yet. At a company our size, how you work matters as much as pedigree. Good structure should help people move faster and trust the work, not slow them down.

Why Hemab

Your writing will sit close to the point where clinical science becomes a potential treatment for patients. People living with serious bleeding disorders have spent too long reacting to bleeds after they happen. We're working to give them the chance to prevent them.

How we treat our people is meant to be an extension of how we think about patients: with care, honesty and respect. We want the same from our hiring experience - transparent, human and clear from first conversation to final answer.

Hemab builds balanced candidate slates and assesses everyone against a single standard. Reasonable adjustments are available at any stage of the hiring experience.

Hemab Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.