FSP Senior Medical Writer (APAC) – Remote, India
Company: PPD Clinical Research Services, part of Thermo Fisher Scientific
Location: Remote, India
Job ID: R-01329712
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Experience Required: Minimum 5+ years
About the Role
PPD Clinical Research Services, a global CRO under Thermo Fisher Scientific, is seeking an experienced Senior Medical Writer (APAC region) to support its expanding Medical Writing FSP Team in India. This role involves delivering high-quality scientific and clinical documentation for global clients, with a focus on operational excellence and regulatory compliance. Experience in Immunology, Oncology, or Vaccines is preferred but not mandatory.
This position offers the opportunity to work with international teams across 100+ countries, supporting impactful research that advances global health.
Key Responsibilities
Act as the primary author for key clinical documents including Clinical Study Reports (CSRs), Study Protocols, and summaries of study data.
Write, research, or edit complex scientific documents such as Protocols, IBs, INDs, MAAs, and other regulatory submissions.
Review documents prepared by junior writers and provide mentorship, training, and guidance on writing processes, therapeutic areas, and regulatory requirements.
Ensure all assigned documents adhere to quality standards, regulatory guidelines, and client-specific expectations.
Contribute to the development of best practices, process improvements, and documentation standards within FSP operations.
Support program management tasks such as timeline development, budget inputs, scope assessments, and contract-related activities.
Represent Medical Writing at project launch meetings, review calls, and cross-functional meetings.
Education and Experience Requirements
Bachelor’s degree in a scientific discipline; Master’s or advanced degree preferred.
Minimum 5+ years of medical writing experience in the pharmaceutical, CRO, or FSP environment.
Additional certifications such as AMWA, EMWA, RAC are advantageous.
Equivalent combinations of education, training, and experience may be considered.
Skills and Competencies
Strong expertise in medical writing, data interpretation, and scientific communication.
Excellent editorial, grammatical, and proofreading abilities.
Strong project management, problem-solving, and negotiation skills.
Effective interpersonal communication and presentation skills.
Comprehensive knowledge of global, regional, and national document development guidelines.
Advanced understanding of therapeutic areas, regulatory submissions, and clinical documentation.
Proficiency with Microsoft Office tools, document management systems, and client-specific templates.
Demonstrated ability to work independently, manage timelines, and deliver high-quality outputs.
What We Offer
PPD Clinical Research Services provides an inclusive, growth-focused environment with:
Competitive salary and comprehensive employee benefits.
Flexible remote working culture and excellent work-life balance.
Award-winning training and learning programs to support career advancement.
A collaborative global environment with strong team support and knowledge sharing.
Opportunities to contribute to research that makes the world healthier, cleaner, and safer.
As part of Thermo Fisher Scientific’s global network of 100,000+ professionals, you will contribute to meaningful scientific innovation and impactful healthcare solutions.
Apply Now
Advance your career in global medical writing with a leading CRO.
Start your journey with PPD Clinical Research Services, a division of Thermo Fisher Scientific, and play a key role in shaping the future of clinical research.
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