The Senior Medical Writer is responsible for various medical writing initiatives as assigned by the Clinical team. The person in this role is responsible for ensuring all documents are written in accordance with applicable regulations and completed on time.
- Provide medical/regulatory writing and editing expertise for protocols and regulatory submission documents (e.g., end of Phase 2 meetings, expedited review applications, Pediatric Investigational Plans, clinical study reports, investigator brochures, meeting packages, IND applications, sections of marketing applications [NDA/MAA/CTD], patient information guides, instructions for use and pharmacovigilance documents)
- Write, review, and edit clinical and technical documents for organization, clarity, language/grammar, consistency, and scientific standards
- Coordinate, synthesize, and integrate scientific and medical input from internal and external contributors to meet deliverable and publication deadlines for clinical documents, manuscripts, abstracts, presentations, etc.
- Author documents while contributing therapeutic expertise, knowledge/skills related to clinical drug development, and scientific/technical expertise
- Experience in performing medical-database searches (e.g., Medline, PubMed, etc.).
- Experience as primary author on scientific publications.
- Generate slide decks and medical affairs deliverables.
SKILLS & REQUIREMENTS:
- Knowledge of FDA and EMEA regulations, GCP and ICH guidelines
- Excellent computer skills with experience using Microsoft Word (Word, Excel, PowerPoint) applications to prepare charts, tables, reports and presentations. Experience with email and calendar programs also required.
- 5+ years medical writing experience. Industry medical writing experience strongly preferred
- NDA experience required
- Life Sciences degree required. PhD/MS in Life Sciences a plus