Life Science PhD Job – Medical Writer II Job at Fortrea
Fortrea is looking for a skilled Medical Writer II to join their dynamic clinical research team in Mumbai. If you have at least 3 years of medical writing experience and a passion for clinical science, this full-time role offers a chance to lead protocol and CSR development, mentor junior writers, and contribute to high-impact medical publications. Apply by July 30, 2025, to be part of a team shaping global healthcare.
About Company
Welcome to Fortrea, a leading company dedicated to providing high-quality medical writing services. We are currently seeking a talented individual to join our team as a Medical Writer II in Mumbai.
Job Posting Details:
- Location: Mumbai
- Time Type: Full time
- Job Requisition ID: 252243
Job Overview:
The Medical Writer II at Fortrea will be responsible for leading the preparation of clinical study protocols, clinical study reports (CSRs), and other clinical documents. The role involves interpretation of clinical, pharmacokinetic, and statistical results, as well as the production of scientific publications and other related documents.
Summary of Responsibilities:
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Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate.
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Work under guidance from colleagues to assist development of protocols, CSRs, and other clinical documents on complex studies and programs.
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Prepare and review patient safety narratives for Medical Writer role.
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Leads project management and coordination of narrative projects.
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Oversee and coordinate other writers on CSR appendices compilation.
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Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
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Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed for Medical Writer role.
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Incorporates internal and/or external review comments on clinical documentation.
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Prioritize and forward plan workload to a high standard; to advise Management of problems promptly.
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Participate independently in internal and external client meetings.
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Lead meetings as appropriate.
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Responsible for project coordination and adherence to project timelines and budget.
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Identify ways to improve the efficiency and quality of work processes.
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Mentor Associate Medical Writers and Medical Writer I, as appropriate.
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Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience.
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Provide training to Medical Writers and other staff as appropriate.
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Represent department in audits and inter-department working groups.
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Comply with Fortrea internal processes and procedures.
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Performs other duties as assigned by Management.
Qualifications:
- Minimum of first degree in life sciences
- Advanced degree (PhD or Masters) preferred
Experience:
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Typically, minimum 3 years medical writing experience including 1 year as medical writing project lead for Life Science PhD Job.
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Excellent command of written and spoken English.
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Good written and verbal communication skills.
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In-depth knowledge of MS Word.
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Good organizational and time management ability.
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Excellent interpersonal skills.
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Knowledge of ICH guidelines applicable to medical writing.
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Good understanding of medical/scientific terminology and experience in data analysis and interpretation.
Physical Demands/Work Environment:
Office environment, Remote/Homebased
Keywords: Medical Writer, Fortrea, Job, Mumbai, Clinical Study Protocols, CSRs, Medical Writing Experience