Medical Writer II
Location: Mumbai, India
Company: Fortrea
Work Mode: On-site
Job Summary
Fortrea is hiring an experienced Medical Writer II to lead the preparation of clinical study protocols, Clinical Study Reports (CSRs), and other regulatory and scientific documents. The role involves the interpretation of clinical, pharmacokinetic, pharmacodynamic, and statistical data, and includes supporting the production of scientific publications. The ideal candidate will coordinate complex writing tasks such as CSR appendices and patient safety narratives, ensuring the timely delivery of high-quality documents that meet internal and sponsor expectations.
Key Responsibilities
Lead the preparation of clinical study protocols, CSRs, and related clinical documents.
Interpret clinical, pharmacokinetic, pharmacodynamic, and statistical results as required.
Support senior writers on complex document development.
Develop scientific publications, abstracts, posters, and manuscripts.
Oversee CSR appendices compilation and narrative writing projects.
Prepare and review patient safety narratives and CSR appendices.
Ensure on-time, high-quality document delivery to sponsors and internal teams.
Provide training and mentorship to junior medical writers.
Foster excellent relationships with internal and external clients to ensure consistent service quality.
Required Skills & Qualifications
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related field.
Prior experience in medical writing, especially in clinical research or regulatory affairs.
Ability to interpret clinical and statistical data effectively.
Strong written and verbal communication skills.
Experience in coordinating document preparation across teams.
Detail-oriented with a commitment to delivering high-quality outputs.
Familiarity with CSR writing, patient safety narratives, and scientific publications.
Perks & Benefits
Opportunity to work with a global leader in clinical research.
Exposure to complex clinical document preparation and regulatory submissions.
Professional development through internal training and mentoring programs.
Collaborative, innovative, and inclusive work environment.
Potential for career progression in clinical writing and regulatory affairs.
Company Description
Fortrea is a global contract research organization (CRO) specializing in clinical development and technology solutions for pharmaceutical, biotechnology, and medical device industries. Operating in over 100 countries and across 20+ therapeutic areas, Fortrea is dedicated to transforming the clinical research landscape by accelerating the delivery of life-saving therapies.
Work Mode
On-site (Mumbai, India)
Call to Action
Ready to lead critical clinical documentation projects? Apply now to join Fortrea's dynamic medical writing team and make a global impact in clinical research.
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