Company: Biotechnology Company
Title: Medical Writer
Contract Position - 6 months with potential extension
Position Summary
Our client is seeking an experienced Medical Writer to develop high-quality clinical and regulatory documents in support of clinical development and regulatory submissions. This role will partner with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, Quality Assurance, and external vendors to produce clear, accurate, and compliant documents.
Key Responsibilities
Author, review, and edit clinical and regulatory documents, including protocols, protocol amendments, clinical study reports, investigator’s brochures, informed consent forms, CTD clinical modules, briefing documents, safety reports, and responses to regulatory questions.
Support clinical development activities by helping prepare clinical development plans, protocols, and related study documents.
Interpret complex clinical and scientific data and communicate findings clearly and accurately.
Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable regulatory guidelines.
Collaborate with cross-functional teams to manage document timelines, review cycles, and submission-ready deliverables.
Review documents prepared by internal teams or external vendors for clarity, consistency, scientific accuracy, and regulatory compliance.
Qualifications
Advanced degree preferred, such as PhD, PharmD, MD, or MSc in Life Sciences, Medicine, Pharmacy, or a related field.
Minimum 3–5 years of medical writing experience in the pharmaceutical, biotech, or CRO industry.
Strong experience writing clinical trial and regulatory submission documents.
Knowledge of drug development, clinical research, clinical study conduct, regulatory requirements, and biostatistical concepts.
Familiarity with medical terminology and coding dictionaries such as MedDRA and WHODrug.
Strong knowledge of ICH/GCP and regulatory submission requirements.
Epilepsy or neurology experience is a plus.
Veeva experience preferred.
Proficiency with Microsoft Word, Excel, PowerPoint, Adobe Acrobat, EndNote, and document management systems.
Ideal Candidate
The ideal candidate is a detail-oriented medical writer who can manage multiple projects, work independently, collaborate effectively with cross-functional teams, and produce clear, well-structured, submission-ready clinical and regulatory documents.