Medical/Scientific Writer

Job Description

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

Qualifications

• • 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.

Additional Information