Department: Medical Affairs with matrix partnership to Research
Reports to: Jigar Amin
Hemab is a clinical-stage biotech company on a mission to develop innovative treatments for neglected bleeding and thrombotic disorders. With sites in Copenhagen and Boston, we combine high-impact science with a collaborative culture as we progress toward commercialization.
We are seeking a Scientific Writer to serve as a critical bridge between our Research and Medical Affairs functions. In this role, you will synthesize complex data into high-quality manuscripts, clinical study reports, investigator brochures, and other documentation that supports peer-reviewed publications, regulatory submissions, and medical communications.
Working directly with research scientists, clinical teams, and regulatory leads, you will interpret experimental findings and communicate results with the precision required for regulatory submissions and peer-reviewed publications. Your expertise will be crucial in maintaining scientific integrity while making our research accessible to diverse audiences. This is a unique opportunity for someone looking to transition into scientific writing who loves the craft of communication, has an eye for detail, and is eager to explore how AI tools can enhance scientific communication and innovation.
You will join a collaborative cross-functional team with close partnerships spanning Medical Affairs, research, regulatory affairs, and clinical development. This integrated structure provides direct access to subject matter experts, source data, and experienced colleagues who offer guidance and support.
Key Responsibilities
Scientific & Regulatory Writing
- Lead the preparation of scientific manuscripts for peer-reviewed publications, demonstrating our research and preclinical findings
- Lead the preparation of patent filings
- Develop and write regulatory documentation including:
- Technical reports, Investigator's Brochures and briefing documents
- Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs)
- Regulatory responses and agency communications
- Create high-quality abstracts, posters, and presentations for scientific conferences
Medical Communications & Affairs Support
- Collaborate with Medical Affairs to develop scientifically accurate medical communications materials
- Prepare scientific brochures, data summaries, and disease-state educational content
- Support the creation of materials for advisory boards and key opinion leader (KOL) engagements
- Contribute to medical information responses and scientific exchange materials
- Assist in developing content for medical education initiatives
Research Operations & Innovation
- Design and implement AI-enabled workflows for scientific content generation, ensuring quality, compliance, and efficiency gains across the organization
- Take part in building evaluation frameworks for early pipeline projects in collaboration with clinical and research scientist to assess and select projects including target evaluation and landscape review
- Partner with research, clinical development, regulatory affairs, and medical affairs teams to ensure scientific accuracy and consistency across all materials.
- Participate in cross-functional meetings to understand program strategy and data interpretation
- Work with external partners, including contract research organizations (CROs) and medical writers, as needed
- Support preparation of investor and partnership presentations when scientific content is required
Required Qualifications
- PhD in life sciences, biomedical sciences, pharmacology, immunology, hematology, or related field
- Demonstrated experience in scientific writing, including peer-reviewed publications as first author or significant contributor
- Strong understanding of clinical drug development processes and regulatory requirements
- Excellent written and verbal communication skills with the ability to translate complex scientific concepts for diverse audiences
- Meticulous attention to detail and commitment to scientific accuracy
- Strong organizational skills and ability to manage multiple projects simultaneously
- Proven ability to work collaboratively in a fast-paced, team-oriented environment
Preferred Qualifications
- Previous experience in biotech or pharmaceutical industry, particularly in early to mid-stage clinical development
- Experience writing regulatory documents (INDs, CTAs, CSRs) or working with regulatory agencies
- Background in hematology, hemostasis, bleeding disorders, or related therapeutic areas
What We Offer
- Opportunity to make a meaningful impact on patients living with rare bleeding disorders who have few or no treatment options
- Collaborative, mission-driven culture with a commitment to scientific excellence
- Work at the forefront of innovation in bleeding disorder therapeutics
- Professional development opportunities and growth within a rapidly expanding organization
