FSP Senior Medical Writer (APAC) – Remote, India
Company: PPD Clinical Research Services (Part of Thermo Fisher Scientific)
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Experience Required: Minimum 5+ years
About the Role
PPD Clinical Research Services, part of Thermo Fisher Scientific, is expanding its India-based Medical Writing FSP Team and is seeking an experienced Senior Medical Writer (APAC region). This position offers the opportunity to work on global clinical research projects, supporting a leading client in the functional service provider (FSP) model. Experience in Immunology, Oncology, or Vaccines is preferred but not mandatory.
The role focuses on delivering high-quality scientific and clinical documentation from planning to final submission. You will collaborate with cross-functional global teams to enable clear, accurate, and compliant scientific communication.
Key Responsibilities
Serve as the primary author for client-assigned documents such as Clinical Study Reports (CSRs), Study Protocols, and related clinical documents.
Research, write, or edit complex regulatory and scientific documents, including IBs, INDs, MAAs, and program-level documentation.
Review documents developed by junior medical writers and provide guidance, mentorship, and training.
Ensure document quality, accuracy, formatting standards, and full compliance with regulatory and organizational guidelines.
Contribute to best practices, writing methodologies, and process optimization within FSP operations.
Support program management tasks, including tracking timelines, identifying out-of-scope activities, and preparing budget or contract-related inputs.
Represent Medical Writing in project launch meetings, review calls, and cross-functional discussions.
Education and Experience Requirements
Bachelor’s degree in a scientific discipline is required; Master’s or advanced degree preferred.
Minimum 5+ years of relevant medical writing experience, preferably within a 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
Expertise in clinical/scientific data interpretation and regulatory writing.
Strong command of English with exceptional writing, editing, and proofreading skills.
Advanced understanding of global clinical document guidelines and regulatory expectations.
Ability to manage multiple projects, meet deadlines, and work independently in a remote environment.
Strong interpersonal skills, problem-solving capability, and negotiation skills.
Proficiency in document management systems, client templates, MS Office tools, and relevant writing applications.
In-depth knowledge in specialized therapeutic or regulatory areas is an added advantage.
What You Will Gain
PPD Clinical Research Services offers a collaborative, growth-oriented global environment, supported by:
A competitive salary and comprehensive benefits package.
Flexible remote working culture and strong work-life balance.
Award-winning learning and development programs to enhance your professional growth.
Opportunities to contribute to global clinical research that advances public health.
Join Thermo Fisher Scientific’s mission-driven organization dedicated to making the world healthier, cleaner, and safer.
Apply Now
Become part of a global team committed to scientific excellence and advancing clinical research.
Start your story with PPD Clinical Research Services, a division of Thermo Fisher Scientific.
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