FSP Medical Writer
Location: Bangalore, Karnataka, India (Fully Remote)
Job Type: Full-Time
Category: Clinical Research
Job ID: R-01343035
Company: Thermo Fisher Scientific (PPD® Clinical Research Portfolio)
About the Organization
Thermo Fisher Scientific, through its PPD® clinical research portfolio, is a leading global Contract Research Organization (CRO) supporting pharmaceutical, biotechnology, and healthcare companies in accelerating drug development. With clinical trials conducted across 100+ countries, the organization combines scientific expertise, digital innovation, and decentralized trial capabilities to bring life-changing therapies to market.
Role Overview
The FSP Medical Writer will be dedicated to a Functional Service Provider (FSP) client engagement, responsible for developing high-quality clinical and regulatory documentation. This role requires expertise in structured content authoring systems and regulatory writing within pharmaceutical or CRO environments.
The selected candidate will collaborate with cross-functional stakeholders to ensure that all documentation meets global regulatory requirements, industry standards, and internal quality benchmarks.
Key Responsibilities
Clinical & Regulatory Writing
Author and edit clinical study reports (CSRs), study protocols, investigator brochures, and regulatory submission documents.
Ensure alignment with ICH guidelines, global regulatory standards, and client-specific requirements.
Contribute to safety-related documents such as DSURs where applicable.
Provide content, structural, and presentation guidance to enhance document clarity and compliance.
Cross-Functional Collaboration
Work closely with clinical, regulatory, safety, and data management teams to gather accurate information.
Review documents prepared by team members and provide constructive feedback.
Maintain proactive communication with stakeholders to ensure timely project delivery.
Structured Content & Innovation
Utilize structured content management systems to streamline document development.
Support automation initiatives and AI-driven content creation workflows.
Demonstrate familiarity with Natural Language Generation tools where applicable.
Project & Quality Management
Manage timelines, deliverables, and quality control processes.
Stay updated on evolving regulatory requirements and industry best practices.
Ensure compliance with internal SOPs and external regulatory frameworks.
Education & Experience Required
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline; advanced degree preferred.
Minimum 2+ years of regulatory medical writing experience.
Prior experience in pharmaceutical, biotechnology, or CRO industry required.
Experience in structured content management systems preferred.
Exposure to safety writing (e.g., DSUR) considered an advantage.
Key Skills & Competencies
Strong knowledge of global regulatory guidelines and drug development processes.
Excellent written and verbal communication skills in English.
Advanced organizational and program management capabilities.
Ability to work independently with sound judgment and problem-solving skills.
Strong interpersonal skills for effective stakeholder engagement.
High attention to detail and quality assurance standards.
Work Schedule & Environment
Standard Monday–Friday schedule.
Fully remote work model within India.
Collaborative global team environment with cross-functional exposure.
Why Apply?
This opportunity offers direct client engagement within a global FSP model, exposure to advanced structured content authoring systems, and participation in innovative clinical documentation processes. Professionals seeking to strengthen expertise in regulatory medical writing and global clinical research operations will find this role strategically aligned with long-term career growth.
Keywords: FSP Medical Writer Jobs India, Regulatory Medical Writing Careers Bangalore, Clinical Study Report Writing Jobs, CRO Medical Writer Roles India, Remote Medical Writing Jobs India, Structured Content Authoring Careers, DSUR Writing Jobs India.
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