About the role
Job Summary
We are seeking an experienced Senior Medical Writer with strong expertise in medical and scientific writing to support Phase 1–3 clinical development programs for pharmaceutical and biologic products. The candidate will work closely with cross-functional teams to develop high-quality clinical and regulatory documents throughout the drug development lifecycle.
Key Responsibilities
- Serve as a primary author and strategic contributor for clinical and regulatory documents supporting Phase 1–3 clinical development.
- Author and review key documents, including Clinical Study Protocols, Protocol Amendments, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), IND, MAA, and other regulatory submission documents.
- Research, interpret, synthesize, and communicate complex clinical and scientific information accurately and clearly.
- Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, and other cross-functional stakeholders.
- Ensure documents meet applicable regulatory requirements, scientific standards, quality standards, and timelines.
- Review and incorporate feedback from subject matter experts and manage multiple review cycles.
- Contribute to improving medical writing processes, templates, and quality standards.
Qualifications & Experience
- Bachelor’s degree in a scientific discipline; advanced degree preferred.
- 5+ years of relevant experience in medical writing, scientific writing, or regulatory writing.
- Prior experience in the pharmaceutical, biotechnology, or CRO industry.
- Demonstrated experience supporting Phase 1–3 clinical trials and authoring clinical/regulatory documents.
- Strong knowledge of clinical development, medical terminology, and scientific writing principles.
- Familiarity with ICH-GCP and regulatory requirements is preferred.
- Additional qualifications/certifications such as AMWA, EMWA, or RAC will be an advantage.
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