Position Title: Senior Medical Reviewer
📍 Location: Mumbai, India
🏢 Department: Clinical
🆔 Job ID: 255628
💼 Employment Type: Full-Time
Job Overview
The Senior Medical Reviewer is responsible for providing expert medical input and review of complex clinical, regulatory, and scientific documents.
This role supports medical writing, medical information services, and safety review activities while ensuring compliance with global regulatory standards. The position also involves training delivery in disease areas and protocol-specific requirements.
Key Responsibilities
1. Medical Review and Input
Perform medical data review of laboratory results, adverse events, coding dictionaries, data tables, listings, and figures.
Provide medical input and review for moderate to complex clinical and regulatory documents including:
Clinical Study Reports (CSRs)
Investigator’s Brochures (IBs)
Protocols and Product Monographs
Clinical & Nonclinical Overviews and Summaries
Manuscripts, Abstracts, and Posters
Advisory Board Meeting (ABM) Reports
Medico-marketing and training materials
Aggregate safety reports and signal detection documents (as required)
2. Medical Information Oversight
Provide oversight and quality assurance for the company’s Medical Information services.
Ensure accurate and compliant communication of medical and product-related information.
3. Training and Knowledge Development
Develop and deliver training sessions on disease states, therapeutic areas, and protocol-specific requirements.
Participate in internal and external training programs to enhance knowledge of drug development, clinical research, and GCP guidelines.
4. Quality and Process Improvement
Identify process gaps or implementation issues in medical and clinical documentation.
Provide recommendations and support for remediation and process optimization.
Assist in developing and reviewing protocols, case report forms, and project-specific tools.
5. Cross-functional Collaboration
Collaborate with Clinical Research, Medical Writing, Regulatory Affairs, and Pharmacovigilance teams.
Contribute medical expertise across multidisciplinary project teams.
Qualifications
Education
MBBS or MD with relevant clinical experience.
Equivalent or relevant experience may be considered in lieu of formal qualification.
Experience Requirements
|
Requirement |
Description |
|---|---|
|
Experience Level |
Minimum 3–4 years in pharmaceutical industry or CRO |
|
Functional Areas |
Clinical Research, Medical Services, or Medical Writing (including Medical Communications) |
|
Document Experience |
Authoring/reviewing complex clinical documents such as CSRs, IBs, Protocols, Clinical Overviews/Summaries, Product Monographs, Publications |
|
Knowledge Areas |
Therapeutic area expertise, drug development lifecycle, clinical and safety data evaluation |
|
Regulatory Knowledge |
Strong understanding of ICH-GCP, clinical trial reporting, and publication standards |
Core Skills and Competencies
Excellent analytical and critical thinking skills to interpret clinical and preclinical data.
In-depth understanding of regulatory document structures and content requirements.
Strong command of medical and scientific terminology.
Proficiency in MS Office Suite (Word, Excel, PowerPoint).
Outstanding written and verbal communication abilities.
Strong collaboration, leadership, and mentoring skills.
Work Environment
Location: Mumbai, India
Travel: Required (as per business needs)
Work Mode: Office-based / Hybrid
Physical Demands: Standard professional office activities
Equal Opportunity Statement
Fortrea is an Equal Opportunity Employer. We embrace diversity and inclusion in all employment practices and provide reasonable accommodations upon request.
Learn more about our EEO & Accommodations policies here.
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