Principal Medical Writer

🔥 2 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients • Serve as lead writer, reviewing team documents and providing training and guidance to junior team members • Advise on document development strategy, regulations, and industry best practices • Collaborate with internal and external clients to support effective and efficient communication • 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 • Provide senior-level review of routine and complex documents • Ensure compliance with quality processes and requirements • Develop and review best practices and lead process improvement initiatives • Develop, review, and manage performance metrics for assigned projects • Serve as backup program manager and resolve out-of-scope activities • Represent the department at project launch, review, and project team meetings

🎯 Requirements

• Demonstrates subject matter and therapeutic area expertise • Experience/ability to research, write, and edit 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 • Ability to train and mentor writers and program managers on document preparation, software for document development, document types, regulatory requirements, and therapeutic area knowledge • Knowledge of quality processes and requirements • Ability to develop and review best practices, methods, and techniques • Ability to manage performance metrics for assigned projects • 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 • Full-time availability on a standard Monday–Friday schedule