Principal Medical Writer

🔥 1 minute ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 1 minute ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide high-quality medical and scientific writing from planning and coordination through final drafts for internal and external clients • Lead writing activities and review team documents • Provide training, mentorship, and guidance to junior writers and program managers • Advise on document development strategy, regulations, and industry best practices • Research, write, and edit clinical study reports and study protocols • Summarize data from clinical studies • Serve as primary author for complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs • Ensure compliance with quality processes and requirements for assigned documents • Develop and review best practices, methods, and techniques, including client-specific processes • Lead process improvement initiatives • Develop, review, and manage performance metrics for assigned projects • Serve as backup program manager and identify and resolve out-of-scope activities • Develop timelines, budgets, forecasts, and contract modifications as needed • Assist business development with client presentations and proposal text review • Attend bid defense meetings and capabilities presentations • Represent the department at project launch, review, and project team meetings • Collaborate with internal and external clients to support effective communication and operational excellence

🎯 Requirements

• Demonstrated subject matter and therapeutic area expertise • Experience researching, writing, and editing clinical study reports and study protocols • Ability to summarize data from clinical studies • Ability to author complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs • Ability to provide senior-level review of routine and complex documents • Knowledge of document preparation software and document types • Knowledge of regulatory requirements and therapeutic areas • Ability to ensure compliance with quality processes and requirements • Ability to develop and review best practices, methods, and techniques • Ability to lead process improvement initiatives • Ability to develop, review, and manage performance metrics • Ability to serve as backup program manager • Ability to develop timelines, budgets, forecasts, and contract modifications • Ability to assist with client presentations, proposal text review, bid defense meetings, and capabilities presentations

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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