Director, Medical Writing: Regulatory Documentation Lead

Hemab Therapeutics; Malmö kommun; On-site; SEK 1,200,000 - 1,800,000; Full time

Job summary

Hemab Therapeutics is seeking a Director, Medical Writing in Malmö to own the clinical and regulatory writing for one lead compound. You will craft strategies and drive documents from protocols to submissions, turning complex data into regulator-ready narratives.

This hands-on leadership role requires coordinating with clinical development, regulatory, biostatistics and safety colleagues to ensure content aligns with strategy and timelines, while maintaining quality and compliance with ICH

Qualifications

• Bachelor’s degree in a scientific discipline with hands-on medical writing experience (10+ years) across biotech/pharma/CRO settings.
• Significant experience authoring clinical and regulatory documents across drug development.
• Strong working knowledge of ICH E3, ICH E6 and relevant FDA/EMA requirements.
• Scientific fluency and ability to interpret clinical trial data and statistical outputs.
• Excellent written English with the ability to present complex science clearly and precisely.
• Strong cross-functional communication and alignment across reviewers.
• Ability to own competing documents and deadlines independently while maintaining quality.

Responsibilities

• Own medical writing for one leading compound from strategy through drafting and finalization.
• Lead development of clinical documents (protocols, CRs, IBs, submission documents)
• Contribute to regulatory and safety document content (briefing documents, responses, DSURs)
• Translate complex clinical and statistical data into clear, regulator-ready narratives.
• Partner with clinical development, regulatory, biostatistics and safety to align content with strategy.
• Drive cross-functional reviews, resolve comments, and maintain scientific accuracy.
• Apply regulatory requirements (ICH E3/E6, FDA/EMA) in all documents.
• Build writing plans and workflows to keep interdependent documents moving on timelines.
• Maintain document quality, version control, and adapt as data/timelines evolve.
• Identify risks early and propose practical solutions for the program team.
• Collaborate with internal teams and external vendors on disclosures in line with transparency rules.

Skills

Medical writing

Regulatory document authoring

Cross-functional collaboration

Regulatory knowledge (ICH E3/E6)

English scientific writing

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MS, PhD, or PharmD)

Job description

Hemab Therapeutics is seeking a Director, Medical Writing in Malmö to own the clinical and regulatory writing for one lead compound. You will craft strategies and drive documents from protocols to submissions, turning complex data into regulator-ready narratives.

This hands-on leadership role requires coordinating with clinical development, regulatory, biostatistics and safety colleagues to ensure content aligns with strategy and timelines, while maintaining quality and compliance with ICH