Senior Medical Writer – Clinical Research
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Job ID: R-01332283
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific is seeking a Senior Medical Writer to join our PPD® clinical research team. This role offers the opportunity to deliver high-quality scientific and medical writing across all stages of clinical development while collaborating with internal and external stakeholders. As a Senior Medical Writer, you will leverage therapeutic area expertise to author, review, and provide guidance on a variety of clinical documents including study protocols, clinical study reports (CSRs), Investigator Brochures (IBs), INDs, and MAAs.
Key Responsibilities
Serve as primary author for routine clinical documents such as CSRs, protocols, and study summaries.
Research, write, and edit complex clinical and scientific documents including IBs, INDs, and MAAs.
Review documents prepared by junior writers and provide training and mentorship on document preparation, regulatory requirements, therapeutic area knowledge, and software tools.
Ensure all deliverables comply with quality processes, client requirements, and global regulatory guidelines.
Develop best practices, methods, and techniques for document preparation and client-specific processes.
Assist with program management activities including developing timelines, budgets, forecasts, and contract modifications.
Represent the medical writing department at project launch meetings, review meetings, and cross-functional project team meetings.
Collaborate effectively with internal and external stakeholders to ensure efficient and accurate communication throughout the document lifecycle.
Required Qualifications & Experience
Education: Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
Experience: Minimum 5+ years of medical writing experience in the pharmaceutical or CRO industry.
Experience in managing and producing regulatory documents (CSR, IB, IND, MAA) required.
Additional certifications such as AMWA, EMWA, or RAC are advantageous.
Skills & Competencies
Excellent data interpretation, medical writing, editing, and proofreading skills.
Strong project management and organizational skills, including timeline and resource management.
Advanced knowledge of global, regional, and national document development guidelines.
In-depth understanding of specialty areas such as preclinical, therapeutic, regulatory submissions, or communications.
Strong decision-making, problem-solving, and negotiation skills.
Excellent oral and written communication and presentation skills.
Proficient in Microsoft Office, document management systems, and client-specific templates.
Ability to mentor junior staff and contribute to process improvements.
Why Join Thermo Fisher Scientific
As a Senior Medical Writer, you will play a key role in ensuring accurate and high-quality clinical documentation that supports regulatory submissions worldwide. Join a leading global CRO and contribute to advancing scientific research and life-changing therapies.
SEO Keywords Optimized: Senior Medical Writer Remote India, Clinical Research Writing Jobs, Regulatory Document Writing India, CSR Protocol Writer, Pharmaceutical CRO Careers India.
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