FSP Senior Medical Writer
Company: Thermo Fisher Scientific
Location: Bangalore (Fully Remote)
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Work Schedule: Monday to Friday
Job Overview
Thermo Fisher Scientific is seeking a highly skilled FSP Senior Medical Writer to support global clinical development and regulatory documentation activities within its Functional Service Provider (FSP) model. This role focuses on developing high-quality clinical and regulatory documents that meet international regulatory standards and support drug development programs.
The successful candidate will collaborate with cross-functional teams, manage document development processes, and ensure compliance with global regulatory requirements. This position offers an opportunity to work on innovative clinical research programs and contribute to the delivery of life-changing therapies across global markets.
Key Responsibilities
Clinical and Regulatory Writing
Develop, write, and edit clinical and regulatory documents including clinical study reports, clinical protocols, investigator brochures, and regulatory submission documents.
Ensure documentation complies with global regulatory guidelines, company standards, and industry best practices.
Provide expert input on document structure, content quality, and presentation standards.
Review and provide feedback on documents prepared by other team members to ensure quality and consistency.
Cross-Functional Collaboration
Collaborate with clinical, regulatory, and scientific teams to gather and verify required information.
Ensure accuracy, completeness, and scientific integrity of clinical documentation.
Build and maintain effective working relationships with internal and external stakeholders.
Project and Process Management
Manage timelines and deliverables for assigned medical writing projects.
Support structured content authoring and document automation processes.
Contribute to continuous process improvements in medical writing operations.
Stay updated with evolving regulatory requirements, clinical development processes, and industry trends.
Quality and Compliance
Ensure adherence to quality control processes and regulatory compliance standards.
Support structured content management systems and AI-driven content development initiatives where applicable.
Maintain high standards of scientific accuracy, clarity, and consistency across deliverables.
Education Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related scientific discipline.
Advanced degree (Master’s or PhD) preferred.
Equivalent combination of education and relevant professional experience may be considered.
Experience Required
Minimum 5+ years of experience in regulatory or medical writing.
Prior experience in the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
Experience in writing clinical study protocols and regulatory documentation is preferred.
Experience with European Union Clinical Trial Regulation (EU CTR) processes is advantageous.
Experience with structured content management systems and AI-driven content creation tools preferred.
Familiarity with Natural Language Generation technologies is an added advantage.
Required Skills and Competencies
Strong knowledge of drug development processes and regulatory guidelines.
Excellent scientific writing, editing, and documentation skills.
Strong organizational and project management capabilities.
Demonstrated leadership ability to guide and mentor medical writing teams.
Strong interpersonal and communication skills.
Ability to work independently and manage multiple projects simultaneously.
High attention to detail and strong problem-solving skills.
Understanding of quality assurance and regulatory compliance processes.
Adaptability and ability to perform in a dynamic global environment.
Work Environment
Fully remote work setup with standard office-based working conditions.
Collaborative global work environment supporting decentralized clinical research operations.
Career Growth and Benefits
Opportunity to work on global clinical trials across multiple therapeutic areas.
Exposure to advanced clinical research technologies and structured content authoring systems.
Access to professional development and learning programs.
Competitive compensation and comprehensive employee benefits.
Flexible working culture supporting work-life balance.
Collaborative global environment focused on innovation, integrity, and scientific excellence.
Uttar Pradesh :
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Siliguri |Illinois :
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