Position: FSP Senior Medical Writer (APAC)
Location: Remote, India
Job ID: R-01329712
Job Type: Full-time
Category: Clinical Research
Work Arrangement: Fully Remote
About the Role
At Thermo Fisher Scientific, your work contributes to making the world healthier, cleaner, and safer. As part of our PPD® clinical research portfolio, you’ll be at the forefront of advancing new therapies, conducting clinical trials in 100+ countries, and delivering impactful medical writing that supports life-changing drug development.
We are expanding our India Medical Writing FSP Team and seeking a Senior Medical Writer to support one of our global clients. Experience in Immunology, Oncology, or Vaccines is valuable but not essential. In this role, you’ll provide high-quality scientific and medical writing, manage end-to-end document delivery, and collaborate closely with clients to ensure operational excellence.
Work Schedule
Other / Flexible Schedule
Work Environment
Office (Remote Work)
Summarized Purpose
As a Senior Medical Writer (FSP), you will:
Serve as the primary author for client documents, ensuring accuracy, compliance, and clarity.
Deliver a variety of clinical and regulatory documents, including study protocols, CSRs, IBs, INDs, and MAAs.
Mentor junior writers, manage timelines, and contribute to process improvement initiatives.
Key Responsibilities
Medical Writing & Document Development
Serve as primary author for FSP client projects.
Write, review, and edit routine and complex clinical and regulatory documents, including:
Clinical Study Reports (CSRs)
Study Protocols
Investigator’s Brochures (IBs)
Investigational New Drug (IND) applications
Marketing Authorization Applications (MAAs)
Summarize and interpret clinical study data accurately.
Ensure all documents comply with regulatory standards, SOPs, and client-specific processes.
Review & Quality Oversight
Review documents prepared by junior writers and provide feedback.
Ensure quality, consistency, and compliance across all deliverables.
Participate in peer reviews and maintain best practice documentation.
Mentoring & Training
Provide training and mentorship to junior writers and project managers.
Guide team members in document development, use of software tools, and understanding regulatory requirements.
Project Management
Contribute to program management activities, including timelines, budgets, and forecasts.
Identify out-of-scope activities and manage change requests.
Represent the department at project launch meetings and client discussions.
Process Improvement
Independently develop and implement best practices, templates, and writing techniques.
Support continuous improvement initiatives to enhance writing quality and efficiency.
Education & Experience
Education
Bachelor’s degree in a scientific discipline required.
Advanced degree (Master’s/PhD) preferred.
Additional qualifications (e.g., AMWA, EMWA, RAC) are advantageous.
Experience
5+ years of relevant medical writing experience.
Experience in the pharmaceutical or CRO industry preferred.
Prior experience working in FSP (Functional Service Provider) setups is desirable.
Knowledge, Skills & Abilities
Excellent medical writing, data interpretation, and editing skills.
Strong understanding of global and regional regulatory guidelines.
Proficient in project management and timeline adherence.
Skilled in problem-solving, negotiation, and stakeholder management.
Strong oral and written communication and presentation abilities.
Expertise in Microsoft Office Suite, document management systems, and client-specific templates.
Knowledge in specialty areas such as preclinical, regulatory submissions, or scientific communications is a plus.
What We Offer
Competitive salary and comprehensive benefits package focused on health and well-being.
Flexible work culture supporting work-life balance.
Access to an award-winning learning and development program for professional growth.
Collaborative, inclusive work environment with global exposure and a local team feel.
Opportunity to be part of a mission-driven organization with 100,000+ colleagues worldwide.
Our Mission & Values
At Thermo Fisher Scientific, we share a common mission:
To enable our customers to make the world healthier, cleaner, and safer.
We uphold core values of Integrity, Intensity, Innovation, and Involvement — working together to:
Accelerate scientific research,
Solve complex challenges,
Drive innovation, and
Support patients in need.
Join us and #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.
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