Company: Thermo Fisher Scientific
Division: PPD Clinical Research Portfolio
Location: Remote, India
Job Type: Full-Time
Industry: Clinical Research | Pharmaceutical | CRO
Experience Required: Minimum 5+ years in medical writing within pharmaceutical, biotechnology, or CRO environments
About the Opportunity
A global leader in clinical research and pharmaceutical services is hiring a Senior Medical Writer to support high-impact clinical development programs. This fully remote role in India offers the opportunity to work within a leading Contract Research Organization (CRO), contributing to regulatory submissions, clinical documentation, and global drug development initiatives.
The Senior Medical Writer will lead the planning, development, and delivery of high-quality clinical and regulatory documents while collaborating with cross-functional teams, sponsors, and global stakeholders.
Key Responsibilities
Serve as primary author for clinical and regulatory documents including:
Clinical Study Reports (CSRs)
Study Protocols
Investigator’s Brochures (IBs)
Investigational New Drug Applications (INDs)
Marketing Authorization Applications (MAAs)
Interpret and summarize complex clinical data for regulatory and scientific audiences.
Lead document planning, content development, editing, and finalization in compliance with global regulatory standards.
Review and quality-check documents prepared by junior medical writers.
Provide mentorship and training on regulatory writing standards, document templates, and therapeutic area expertise.
Ensure adherence to ICH, regional, and sponsor-specific guidelines.
Contribute to process optimization and development of best practices.
Support program management activities, including timelines, forecasts, budget inputs, and scope management.
Represent medical writing at project launch meetings and cross-functional team discussions.
Identify and proactively resolve out-of-scope activities.
Required Qualifications
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline.
Advanced degree (MSc, PhD, PharmD, MD) preferred.
Certifications such as AMWA, EMWA, or RAC are advantageous.
Experience:
Minimum 5+ years of experience in medical writing within pharmaceutical, biotechnology, or CRO settings.
Demonstrated experience authoring regulatory and clinical documents.
Experience in global regulatory submissions preferred.
Core Skills and Competencies
Advanced medical writing, editing, and proofreading expertise.
Strong clinical data interpretation and scientific analysis skills.
In-depth knowledge of global and regional regulatory guidelines.
Therapeutic area expertise (preclinical, regulatory, or clinical domains).
Strong project management and stakeholder coordination capabilities.
Excellent verbal and written communication skills.
Proficiency in Microsoft Office and document management systems.
Ability to work independently in a fully remote, cross-functional environment.
Work Environment
Fully Remote (India)
Standard Monday to Friday work schedule
Office-based virtual work environment
Accessibility & Equal Opportunity
The organization is committed to providing reasonable accommodations for individuals with disabilities during the application and interview process.
As an Equal Opportunity Employer, all qualified applicants will receive consideration for employment without discrimination based on legally protected characteristics.
About the Organization
Thermo Fisher Scientific is a global leader in serving science, with annual revenues exceeding $40 billion. Through its clinical research division PPD, the company supports pharmaceutical and biotechnology clients in accelerating drug development and delivering innovative therapies to patients worldwide. The organization combines scientific expertise, regulatory excellence, and advanced technologies to bring life-changing treatments to market.
Why Apply Through ThePharmaDaily.com?
Access global pharmaceutical and CRO career opportunities
Discover remote clinical research and regulatory writing roles
Stay updated on high-demand life sciences careers
If you are an experienced medical writer seeking a leadership-driven role in clinical research and regulatory documentation, apply now to advance your career in global drug development.
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