Document Review Specialist II – Medical Writing
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Job ID: R-01333352
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific is seeking a Document Review Specialist II – Medical Writing to ensure high-quality, accurate, and compliant documentation for clinical research projects. This role is responsible for reviewing regulatory submissions, integrated clinical study reports (CSRs), serious adverse event (SAE) narratives, study protocols, and publications, ensuring scientific accuracy, regulatory compliance, and clarity.
As a senior-level reviewer, you will maintain document integrity, guide authors, and mentor colleagues to achieve superior quality standards that meet or exceed client expectations.
Key Responsibilities
Review and quality-check highly technical documents created internally or externally, ensuring accuracy, scientific logic, and regulatory compliance.
Verify data in tables against source documents and confirm consistency with regulatory standards (e.g., ICH, FDA, EMA).
Edit for clarity, flow, grammar, and audience-appropriate scientific language.
Provide guidance to authors and stakeholders on review processes, maintaining professional standards across all document types.
Adjust workflows to accommodate high-priority review requests while maintaining timelines.
Maintain updated knowledge of regulatory guidelines, industry standards, templates, and best practices.
Ensure document integrity and quality in all deliverables for clinical and regulatory submissions.
Required Qualifications & Experience
Education: Bachelor’s degree or equivalent in a life sciences, medical, or related discipline.
Experience: Minimum 5+ years of quality review or medical writing experience in the pharmaceutical, biotech, or CRO industry.
Proven experience in reviewing regulatory documents including CSR, Protocols, ICF, IB, IND modules, and related clinical documentation.
Familiarity with document management systems, electronic submission platforms, and medical writing tools.
Skills & Competencies
Strong knowledge of GCP, FDA, EMA, ICH guidelines, and global regulatory requirements.
Excellent attention to detail while maintaining the overall document objectives and scientific message.
Strong analytical and critical thinking skills to evaluate content for accuracy and clarity.
Effective oral and written communication skills, with the ability to mentor junior staff.
Advanced computer literacy and proficiency in document management systems.
Ability to work independently or collaboratively within cross-cultural, geographically dispersed teams.
Capability to remain motivated and perform efficiently under tight deadlines.
Work Schedule & Environment
Standard working hours: Monday to Friday
Flexible, fully remote work option with collaboration across global clinical research teams.
Why Join Thermo Fisher Scientific
As a Document Review Specialist II, you will play a critical role in ensuring the quality and compliance of medical writing outputs that support global drug development programs. Your expertise will directly contribute to patient safety, regulatory success, and operational excellence in clinical research.
SEO Keywords Optimized: Medical Writing Jobs Remote India, Clinical Document Review Careers, Regulatory Document Reviewer India, CSR and Protocol Review Jobs, Pharmaceutical CRO Careers India.
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