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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.
Job Responsibility:
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
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
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
Requirements:
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
Nice to have:
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
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