Job Description
- Position Overview
- We are seeking an experienced Medical Writer to join our Medical Affairs team. The ideal candidate will develop high-quality scientific content across diverse therapeutic areas for pharmaceutical and biotechnology clients.
- This role requires strong scientific writing skills, attention to detail, and the ability to translate complex clinical data into clear, compliant communications for various stakeholders.
- Key Responsibilities
- Scientific Content Development
- Develop and coordinate medical communications deliverables including slide decks, congress materials, manuscripts, abstracts, posters, and advisory board presentations
- Prepare regulatory documents such as clinical study reports, investigator brochures, and informed consent forms
- Create publications for peer-reviewed journals following GPP3/ICMJE guidelines
- Develop educational materials for healthcare professionals and patient-focused content
- Project Management
- Manage multiple projects simultaneously while meeting tight deadlines and quality standards
- Coordinate cross-functional reviews with medical, regulatory, and commercial stakeholders
- Track project timelines, budgets, and deliverables using project management tools
- Participate in client meetings and status update calls
- Literature and Data Analysis
- Conduct comprehensive literature searches and data extraction from clinical trial databases
- Synthesize scientific data from clinical studies, meta-analyses, and systematic literature reviews
- Ensure accuracy and consistency of scientific content with source documents
- Maintain awareness of current therapeutic landscape and competitive intelligence
- Quality and Compliance
- Ensure all content adheres to regulatory guidelines (FDA, EMA, ICH-GCP)
- Implement client style guides, brand guidelines, and standard operating procedures
- Participate in quality control processes and peer review activities
- Maintain document version control and archival procedures
- Client Relationship Management
- Build and maintain strong client relationships through responsive communication
- Understand client needs and provide strategic recommendations
- Contribute to proposal development and scoping activities
- Support new business development initiatives
- Scientific Content Development
- Education:
- Advanced degree (PhD, PharmD, MD, MS) in life sciences, pharmacy, medicine, or related field. Bachelor's with exceptional experience considered.
- Experience:
- Minimum 4 years in medical writing (pharmaceutical industry, CRO, or medical communications agency) with proven deliverables across publications, regulatory documents, and congress materials.
- Skills:
- Expert medical writing, Microsoft Office proficiency, reference management software, clinical trial databases knowledge, strong project management, excellent communication.
- Preferred
- Veeva experience, therapeutic expertise (oncology, immunology, metabolic disorders), creative designing, HEOR knowledge, team mentoring experience.
- Education: