Medical Writer

Responsibilities:
- Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented), including CSRs, Investigator Brochures, safety narratives, safety reports, ISS/ISE, and eCTD clinical summary documents for IND, NDA, MAA, and BLA applications and amendments.
- Plan and prepare clinical and regulatory documents for all phases of clinical drug development.
- Organize, analyze, and interpret scientific and statistical data; search and analyze published literature.
- Define problems, establish facts, draw valid scientific conclusions, and propose solutions/corrective actions.
- Work with colleagues, physicians, clinical scientists, and statisticians to complete projects on time.
- Collaborate with project teams to respond to health authority questions and requests.
- Develop and update SOPs, processes, templates, style guides, and manuals.

Qualifications:
- Bachelor’s degree with a focus in science or related field required; advanced degree preferred.
- 5+ years of regulatory medical writing experience required.
- Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, ICH), and scientific principles; knowledge of medical terminology and statistical methodology.
- Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated safety/efficacy summaries.
- Ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; proficiency in Microsoft Word.
- Strong English command (grammar, style, logical progression); ability to edit from copy editing through major rewriting.
- Experience with document templates/toolbars and proper version control.
- Demonstrated leadership, strong project management, organized and self-motivated; strong attention to detail.