Senior Medical Writing Director: Clinical & Regulatory Strategy

Hemab Therapeutics; Indiana (PA); Vor Ort; USD 154.000 - 278.000; Vollzeit

Zusammenfassung

Hemab Therapeutics is seeking a Director, Medical Writing to own the clinical and regulatory writing for one compound in development. You will craft clear, regulatory-ready narratives from complex clinical and statistical data, coordinating with clinical, regulatory, biostatistics and safety teams across Copenhagen and Cambridge.

This hands-on leadership role requires deep experience in clinical/regulatory documentation, mastery of ICH E3/E6, and a proven ability to drive documents to submission

Qualifikationen

• Bachelor’s degree or higher in a scientific field with 10+ years medical writing experience in biotechnology, pharmaceutical or CRO clinical research environments.
• 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.

Aufgaben

• 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.

Kenntnisse

Medical writing

Regulatory writing

ICH guidelines

English writing

Cross-functional collaboration

Independent ownership

Ausbildung

Bachelor's degree in a scientific discipline

MS/PhD/PharmD (nice to have)

Jobbeschreibung

Hemab Therapeutics is seeking a Director, Medical Writing to own the clinical and regulatory writing for one compound in development. You will craft clear, regulatory-ready narratives from complex clinical and statistical data, coordinating with clinical, regulatory, biostatistics and safety teams across Copenhagen and Cambridge.

This hands-on leadership role requires deep experience in clinical/regulatory documentation, mastery of ICH E3/E6, and a proven ability to drive documents to submission