Job Title:
Senior Medical Writer – FSP (Functional Service Provider)
Location: India (Remote/On-site/Flexible)
Department: Medical Writing – Clinical Research Services
Company: Thermo Fisher Scientific (PPD – Part of Thermo Fisher Scientific)
Company Overview:
At Thermo Fisher Scientific, you’ll find meaningful work that makes a global impact. Through our PPD clinical research services portfolio, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. With trials conducted in over 100 countries, we are driving the future of clinical research through laboratory, digital, and decentralized services.
We empower our employees with the resources, development, and support needed to grow their careers and deliver life-changing therapies to patients worldwide.
Position Summary:
We are expanding our India-based Medical Writing FSP Team and seeking a Senior Medical Writer to join our dedicated FSP team. In this role, you will provide high-quality scientific and regulatory medical writing support for a specific client.
Experience in Immunology, Oncology, or Vaccines is highly desirable, though not mandatory.
Key Responsibilities:
Writing & Documentation:
Act as primary author for clinical and regulatory documents including:
Clinical Study Reports (CSRs)
Study Protocols
Investigator Brochures (IBs)
Investigational New Drug (IND) applications
Marketing Authorization Applications (MAAs)
Research, write, and/or edit complex scientific content across document types.
Ensure content complies with regulatory requirements and client-specific guidelines.
Collaboration & Communication:
Collaborate with internal and external stakeholders to ensure high-quality deliverables.
Represent the Medical Writing department at project launches, review meetings, and cross-functional team discussions.
Quality Review & Mentorship:
Review work from junior medical writers and provide editorial feedback.
Mentor and train junior staff in medical writing best practices, software use, and regulatory standards.
Process & Project Management:
Support or lead project timelines, budgets, forecasts, and contract modifications.
Identify and resolve out-of-scope activities or risks to deliverables.
Contribute to process improvement initiatives and development of best practices.
Education & Experience Requirements:
Bachelor’s degree in a life science, medical, or related discipline (required)
Advanced degree (e.g., MSc, PhD, PharmD) preferred
5+ years of relevant medical writing experience
Prior experience in the pharmaceutical industry or a CRO (preferred)
Experience working within FSP models (preferred)
Certifications such as AMWA, EMWA, RAC (advantageous)
Skills & Competencies:
Excellent medical writing and data interpretation skills
Strong editing, grammar, and proofreading abilities
Proficient in project management and multitasking
Skilled in stakeholder communication and negotiation
Working knowledge of global regulatory and clinical documentation guidelines
Proficiency in Microsoft Office (Word, Excel, Outlook), document management systems, and client-specific templates
Knowledge in specialty areas such as preclinical, therapeutic areas, or regulatory submissions
What We Offer:
Competitive salary and comprehensive benefits package
Access to award-winning learning and development programs
Flexible working culture that promotes work-life balance
Collaborative, supportive teams and global career opportunities
A mission-driven culture rooted in our core values:
Integrity
Intensity
Innovation
Involvement
Our Mission:
To enable our customers to make the world healthier, cleaner, and safer.
Join over 100,000 colleagues across the globe as we accelerate research, solve complex scientific challenges, and deliver on the promise of science.
#StartYourStory
Apply now to be part of PPD, a division of Thermo Fisher Scientific, where diverse backgrounds, experiences, and perspectives are truly valued.
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