Medical Writer II-CDS
Location: Mumbai, India
Company: Fortrea
Work Mode: On-site
Job Summary
Fortrea is hiring a skilled Medical Writer II-CDS to lead the development of Clinical Study Reports (CSRs), clinical study protocols, patient safety narratives, and scientific documents including abstracts and manuscripts. This role requires interpretation of complex clinical, pharmacokinetic, pharmacodynamic, and statistical data while ensuring high-quality documentation in line with ICH and regulatory guidelines. The position also offers mentorship opportunities and involvement in process improvements within a global contract research environment.
Key Responsibilities
Prepare CSRs, clinical study protocols, and other regulatory documents.
Interpret clinical, pharmacokinetic, pharmacodynamic, and statistical data.
Develop scientific publications, abstracts, posters, and manuscripts.
Oversee CSR appendices compilation and narrative writing projects.
Mentor junior medical writers and review their deliverables.
Collaborate on Statistical Analysis Plan (SAP) and TFL reviews to ensure data accuracy in CSRs.
Manage multiple writing projects while ensuring quality and adherence to timelines.
Identify process improvements for medical writing activities.
Participate in internal and external client meetings and lead discussions as required.
Ensure compliance with Fortrea’s SOPs, regulatory guidelines, and industry standards.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences or related field (Master’s or PhD preferred).
Minimum 3 years of medical writing experience with at least 1 year as a project lead.
Excellent command of written and spoken English.
Proficiency in MS Word and document formatting tools.
Strong organizational, time management, and communication skills.
In-depth knowledge of ICH guidelines related to medical writing.
Ability to interpret complex medical and statistical data accurately.
Excellent interpersonal skills and the ability to mentor junior writers.
Perks & Benefits
Opportunity to work with a globally recognized CRO.
Exposure to a wide range of therapeutic areas and clinical documentation types.
Structured training and development programs.
Collaborative and supportive work environment.
Potential career advancement in clinical research and regulatory writing.
Company Description
Fortrea is a leading global contract research organization (CRO) providing clinical development and technology solutions to the pharmaceutical, biotechnology, and medical device industries. Operating across more than 100 countries and 20+ therapeutic areas, Fortrea is committed to accelerating the development of life-saving therapies worldwide.
Work Mode
On-site (Mumbai, India)
Call to Action
Ready to take your medical writing career to the next level? Apply now to join Fortrea’s expert team and make a meaningful impact in global clinical research.
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