FSP Medical Writer
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Bangalore, India | Fully Remote
Job Type: Full-Time | Remote
Work Schedule: Standard (Mon–Fri)
Experience: Typically 2+ Years (Medical Writing / Regulatory Writing)
Qualification: Bachelor’s Degree in Scientific Discipline (Advanced Degree Preferred)
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is seeking an FSP Medical Writer to support clinical and regulatory documentation within its Functional Service Partnership (FSP) model.
The Medical Writer will be responsible for developing, editing, and managing high-quality clinical and regulatory documents such as clinical study reports, protocols, investigator brochures, and regulatory submissions. The role involves working closely with cross-functional teams to ensure accuracy, compliance, and timely delivery of documents.
This position plays a critical role in ensuring that clinical trial documentation meets regulatory standards and supports drug development and approval processes.
Key Responsibilities
1. Medical Writing & Document Development
Write and edit clinical and regulatory documents including:
Clinical Study Reports (CSR)
Protocols
Investigator Brochures (IB)
Regulatory submissions
Ensure clarity, accuracy, and scientific consistency in all documents.
2. Collaboration & Content Development
Collaborate with cross-functional teams to gather required information.
Ensure completeness and accuracy of document content.
Provide input on document structure, format, and presentation.
Review and provide feedback on documents prepared by team members.
3. Regulatory Compliance & Quality Assurance
Ensure documents comply with regulatory guidelines and industry standards.
Maintain adherence to company templates and quality processes.
Apply knowledge of drug development and regulatory requirements.
Support quality control and review processes.
4. Project Management & Delivery
Manage timelines and deliverables for assigned writing projects.
Ensure timely completion of documents as per project schedules.
Prioritize tasks and manage multiple assignments efficiently.
5. Advanced Writing Tools & Innovation
Work with structured content authoring systems.
Utilize automation tools and AI-based content creation where applicable.
Apply knowledge of Natural Language Generation (NLG) tools.
Support improvements in writing processes and efficiency.
6. Continuous Learning & Industry Awareness
Stay updated with regulatory guidelines and industry trends.
Maintain knowledge of evolving medical writing standards.
Contribute to best practices in medical writing.
Required Skills
Medical Writing & Regulatory Knowledge
Strong experience in regulatory and clinical writing.
Knowledge of clinical trial documents and drug development processes.
Understanding of regulatory guidelines and submission requirements.
Experience with safety writing (e.g., DSUR) is advantageous.
Writing & Communication Skills
Excellent writing, editing, and proofreading skills.
Strong command of English language and grammar.
Ability to present complex scientific information clearly.
Strong interpersonal communication skills.
Analytical & Organizational Skills
Strong attention to detail and document accuracy.
Good organizational and project management skills.
Ability to manage multiple projects and deadlines.
Strong problem-solving and decision-making ability.
Technical & Tools Knowledge
Experience with structured content management systems.
Familiarity with AI-driven content creation tools.
Understanding of Natural Language Generation (NLG) concepts.
Leadership & Collaboration
Ability to mentor and guide junior writers.
Strong teamwork and collaboration skills.
Ability to work independently and take ownership of deliverables.
Preferred Qualifications
Advanced degree in Life Sciences or related field.
Experience in pharmaceutical or CRO environment.
Experience in safety writing and regulatory submissions.
Familiarity with structured authoring and automation tools.
Key Competencies
Clinical and regulatory medical writing
Document development and quality control
Regulatory compliance and submission standards
Project and timeline management
Structured content authoring and automation
Cross-functional collaboration
Attention to detail and scientific accuracy
About the Company
Thermo Fisher Scientific is a global leader in scientific services and technologies, supporting research, drug development, and healthcare innovation worldwide.
Through its clinical research division, PPD Clinical Research Services, the organization provides end-to-end clinical trial services including clinical operations, data management, regulatory affairs, and medical writing.
Operating in more than 100 countries with over 100,000 employees globally, the company partners with pharmaceutical and biotechnology organizations to accelerate the development of innovative therapies and deliver life-changing treatments to patients around the world.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
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Rostock |Saarland :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Bangkok |Israel :
Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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