Job Title: Senior Medical Writer – Remote, India
Job ID: R-01332283
Job Type: Full-time
Category: Clinical Research
Location: Remote, India
Join Thermo Fisher Scientific’s Clinical Research Services and contribute to life-changing therapies by producing high-quality medical and scientific documentation. As a Senior Medical Writer, you will manage the creation, review, and delivery of clinical trial documents, ensuring compliance with regulatory standards and best practices. You will collaborate with internal and external stakeholders, support program management, and mentor junior writers to drive operational excellence and scientific integrity.
Serve as the primary author for routine clinical documents such as Clinical Study Reports (CSRs), Study Protocols, and data summaries from clinical trials.
Research, write, and edit complex clinical and program-level documents including Investigator Brochures (IBs), INDs, and MAAs.
Review documents prepared by junior writers and provide mentorship on regulatory requirements, document development tools, and therapeutic area expertise.
Ensure all deliverables comply with quality processes, client standards, and regulatory guidelines.
Develop and implement best practices for document preparation and review across projects.
Support program management tasks, including timelines, budgets, forecasts, and contract modifications.
Represent the medical writing function in project meetings, reviews, and cross-functional team discussions.
Education: Bachelor’s degree in a scientific discipline; advanced degree preferred.
Experience: Minimum 5+ years of medical writing experience in the pharmaceutical or CRO industry.
Additional qualifications such as AMWA, EMWA, or RAC certifications are advantageous.
Equivalent combinations of education, training, and directly related experience may also be considered.
Strong expertise in data interpretation, medical writing, editing, and proofreading.
In-depth knowledge of global, regional, and national regulatory document guidelines.
Familiarity with specialty areas such as preclinical, therapeutic, regulatory submissions, and scientific communications.
Strong project management, problem-solving, and decision-making skills.
Excellent oral and written communication with presentation proficiency.
Skilled in document management systems and client-specific templates; proficiency with Excel, Outlook, and other relevant applications.
Ability to mentor and guide junior staff while ensuring high-quality deliverables.
Strong interpersonal and negotiation skills, capable of building effective cross-functional relationships.
Global Impact: Contribute to innovative clinical trials that improve patient outcomes worldwide.
Career Growth: Gain opportunities to lead projects, develop specialized expertise, and mentor team members.
Collaborative Environment: Work with a diverse team of experts across clinical research disciplines.
Flexible Work: Fully remote role with support for professional growth and work-life balance.
Industry Leadership: Be part of a global organization driving scientific innovation and healthcare solutions.
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, employing 100,000+ professionals worldwide. Our mission is to enable customers to make the world healthier, cleaner, and safer. Learn more at www.thermofisher.com.
Equal Opportunity Employer: Thermo Fisher Scientific promotes diversity, equity, and inclusion in the workplace.
Apply Today to join a team dedicated to advancing clinical research and delivering impactful medical solutions globally.
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