Fortrea is a prominent global contract research organization (CRO) known for its scientific excellence and decades of experience in clinical development. With a presence in over 90 countries, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to provide a comprehensive suite of clinical development, patient access, and technology solutions. The company focuses on advancing drug and device development and improving patient outcomes.
Job Overview: Medical Writer I – CDS
Fortrea is seeking a Medical Writer I in Clinical Documentation Services to join their Mumbai team. This role involves preparing critical clinical documents, including manuscripts, protocols, clinical study reports (CSRs), and patient safety narratives. The position is pivotal for ensuring that high-quality, accurate documentation is prepared according to regulatory standards and company guidelines.
Key Responsibilities
- Document Preparation: Draft and finalize manuscripts, protocols, CSRs, and other clinical documents, with attention to clinical data and statistical analysis.
- Guidance and Collaboration: Work under supervision for complex projects and collaborate with colleagues to develop clinical documentation.
- Patient Safety Narratives: Lead the preparation and review of safety narratives.
- Project Management: Oversee the coordination of manuscript and CSR appendix compilation projects, ensuring timelines and budgets are met.
- Quality Assurance: Ensure documents comply with Fortrea/Client SOPs, ICH guidelines, and relevant regulatory requirements.
- Review Participation: Engage in the review of Statistical Analysis Plans (SAP) and Tables, Figures, and Listings (TFLs) for CSRs, and provide feedback.
- Mentorship: Support and mentor Associate Medical Writers, offering peer review as appropriate.
- Audit Representation: Act as a department representative during audits and inter-departmental meetings.
- Process Adherence: Follow Fortrea’s internal processes and complete other duties as assigned by management.
Qualifications and Skills
- Education: A background in life sciences or a related field (e.g., B.Pharm, M.Pharm, M.Sc., or equivalent) is typically required.
- Experience: Prior experience in clinical writing or related documentation roles within a pharmaceutical or CRO setting is preferred.
- Technical Skills: Strong understanding of clinical study documentation, statistical data interpretation, and regulatory requirements.
- Communication: Excellent technical writing, communication, and project coordination skills.
- Teamwork: Ability to work collaboratively within teams and mentor junior staff.
- Attention to Detail: High accuracy in handling data and maintaining document integrity.
