Document Review Specialist II – Medical Writing | Thermo Fisher Scientific | Remote Clinical Research Jobs in India
Company: Thermo Fisher Scientific
Division: PPD Clinical Research Services
Job Role: Document Review Specialist II – Medical Writing
Job Location: Bangalore
Job Type: Full-Time
Work Mode: Fully Remote
Industry: Clinical Research | Medical Writing | CRO | Regulatory Affairs
Experience Required: 2+ Years
Eligibility: Life Sciences, Pharmacy, Biotechnology, Medical, or related graduates/postgraduates
About the Company
Thermo Fisher Scientific is one of the world’s leading life sciences organizations delivering innovative solutions in clinical research, laboratory services, biotechnology, and pharmaceutical development. Through its PPD Clinical Research portfolio, the company supports global drug development programs across more than 100 countries, helping accelerate the delivery of life-changing therapies worldwide.
The organization is recognized globally for its contribution to clinical trials, regulatory research, decentralized clinical trial services, and scientific innovation. Professionals joining the company gain exposure to international clinical research standards, advanced medical writing systems, and high-impact pharmaceutical projects.
Job Overview
Thermo Fisher Scientific is hiring experienced professionals for the position of Document Review Specialist II – Medical Writing. This opportunity is ideal for candidates with strong expertise in reviewing regulatory and scientific documents within the pharmaceutical, biotechnology, or CRO industry.
The selected candidate will work remotely as part of the Medical Writing Functional Service Partnership (FSP) team and will support global clients by ensuring high-quality review and compliance of clinical and regulatory documents according to international standards and editorial guidelines.
Candidates with prior experience in reviewing Clinical Study Reports (CSR), Protocols, Investigator Brochures (IB), Informed Consent Forms (ICF), and Patient Safety Narratives are strongly preferred.
Key Responsibilities
Review highly technical scientific and regulatory documents for quality, accuracy, consistency, and compliance.
Evaluate and verify data presented in tables, figures, listings, and supporting clinical documentation.
Review and edit scientific content for grammar, clarity, readability, flow, and regulatory alignment.
Ensure adherence to company templates, editorial standards, SOPs, and client-specific guidelines.
Support review of:
Clinical Study Reports (CSR)
Protocols and Amendments
Investigator Brochures (IB)
Informed Consent Forms (ICF)
Submission Documents
Patient Safety Narratives
Collaborate with cross-functional clinical research and medical writing teams.
Raise scientific and editorial queries to authors wherever clarification is required.
Maintain awareness of evolving global regulatory guidelines including ICH, FDA, and GCP standards.
Handle multiple projects and priority review timelines efficiently in a remote work environment.
Eligibility Criteria
Educational Qualification
Bachelor’s degree or equivalent qualification in:
Pharmacy
Life Sciences
Biotechnology
Biomedical Sciences
Medicine
Clinical Research
Related healthcare disciplines
Experience Required
Minimum 2+ years of experience in:
Medical Writing
Regulatory Document Review
Clinical Research Documentation
CRO or Pharmaceutical Industry operations
Preferred Experience
Experience reviewing:
CSR
Protocols
IB
ICF
Regulatory submission documents
Prior experience in CRO client-dedicated projects preferred.
Knowledge of formatting and template compliance in Microsoft Word is an advantage.
Required Skills
Strong understanding of:
Medical terminology
Clinical research documentation
Regulatory writing standards
ICH-GCP guidelines
FDA and international regulatory requirements
Excellent English communication and grammar skills.
Strong analytical and scientific review capabilities.
High attention to detail and document quality.
Good organizational and project management skills.
Ability to work independently and in globally distributed cross-functional teams.
Advanced computer literacy and document management system knowledge.
Why Join Thermo Fisher Scientific?
Opportunity to work with a globally recognized CRO and life sciences leader.
Exposure to international clinical research and regulatory projects.
Flexible remote working culture.
Career growth through structured learning and development programs.
Collaborative and innovation-driven work environment.
Competitive compensation and employee wellness benefits.
Opportunity to contribute to global healthcare advancements and drug development programs.
Keywords for Job Seekers
Medical Writing Jobs in Bangalore, Remote Medical Writing Jobs India, Clinical Research Jobs India, Regulatory Writing Jobs, CRO Jobs for Experienced Candidates, CSR Review Jobs, Protocol Review Specialist, Pharmacovigilance and Medical Writing Careers, Thermo Fisher Scientific Careers, PPD Clinical Research Jobs, Regulatory Document Review Jobs, Life Sciences Remote Jobs, Clinical Documentation Specialist Jobs
How to Apply
Interested candidates with experience in medical writing, clinical documentation review, and regulatory affairs can apply through the official careers portal of Thermo Fisher Scientific for the Document Review Specialist II – Medical Writing role.
For more latest Clinical Research, Pharmacovigilance, Medical Writing, Regulatory Affairs, and Biotechnology jobs, visit ThePharmaDaily.com.
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