FSP Senior Medical Writer
Location: Bangalore, India
Job ID: R-01339137
Job Type: Full-Time
Category: Clinical Research
Work Mode: Fully Remote
Work Schedule: Standard (Monday–Friday)
Work Environment: Office-Based
Job Overview
Thermo Fisher Scientific is seeking an experienced FSP Senior Medical Writer to support global clinical research and regulatory documentation activities within its clinical research services portfolio. This role involves developing high-quality clinical and regulatory documents, ensuring compliance with international regulatory standards, and collaborating with cross-functional teams to support drug development programs.
The position is ideal for experienced medical writing professionals with strong expertise in regulatory writing, structured content authoring, and clinical trial documentation within pharmaceutical or contract research environments.
Key Responsibilities
Develop, write, and edit clinical and regulatory documents, including clinical study reports, study protocols, investigator brochures, and regulatory submissions.
Ensure documentation complies with global regulatory guidelines, industry standards, and organizational quality requirements.
Collaborate with cross-functional teams to gather data and ensure accuracy, completeness, and scientific consistency of documents.
Provide strategic input on document structure, content quality, and presentation standards.
Review and provide feedback on documents prepared by other medical writers.
Manage project timelines and deliverables to ensure timely submission of documentation.
Maintain awareness of evolving regulatory requirements, industry trends, and best practices in medical writing.
Support structured content authoring initiatives and automation-driven content development processes.
Educational Qualifications and Experience Required
Bachelor’s degree in a scientific discipline or equivalent qualification (advanced degree preferred).
Minimum 5+ years of regulatory medical writing experience.
Proven experience working in the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
Experience in clinical protocol development is advantageous.
Experience with European Union Clinical Trial Regulation (EU CTR) preferred.
Experience working with structured content management systems and AI-driven content creation tools is desirable.
Familiarity with Natural Language Generation technologies preferred.
Core Skills and Competencies
Extensive knowledge of regulatory guidelines and drug development processes.
Strong clinical research documentation and regulatory submission expertise.
Excellent organizational and project management capabilities.
Strong leadership and mentoring skills.
Effective communication and stakeholder collaboration abilities.
Understanding of quality control processes and compliance standards.
High level of independence in decision-making and problem-solving.
Adaptability and strong attention to detail in a dynamic research environment.
Work Environment and Career Growth
Opportunity to contribute to global clinical trials across multiple therapeutic areas.
Exposure to innovative research frameworks, decentralized trials, and digital clinical solutions.
Collaborative global work environment with strong professional development programs.
Competitive compensation and comprehensive employee benefits.
Flexible work culture supporting work-life balance and continuous career growth.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Greece |North Island :
Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
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