Title: Senior Medical Writer
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Medical Writing – Remote
Company Overview:
PPD® Clinical Research Services, part of Thermo Fisher Scientific, is a leading global contract research organization (CRO) delivering innovative solutions to advance the development of life-changing therapies. Our team combines scientific expertise with operational excellence to help clients bring cures to market efficiently and compliantly.
Role Overview:
We are seeking a Senior Medical Writer to provide high-quality medical and scientific writing across clinical research projects. This role involves authorship of routine and complex documents, review and mentoring of junior writers, and collaboration with internal and external stakeholders to ensure regulatory and scientific excellence.
Key Responsibilities:
Serve as primary author for routine documents, including clinical study reports (CSRs), study protocols, and clinical data summaries.
Research, write, and review complex scientific and program-level documents such as Investigator’s Brochures (IBs), Investigational New Drug (IND) applications, and Marketing Authorization Applications (MAAs).
Review documents prepared by junior writers and provide mentorship and training on regulatory document preparation, software usage, and therapeutic area knowledge.
Ensure compliance with quality processes, client-specific requirements, and global, regional, and local regulatory guidelines.
Contribute to the development of best practices, methods, and techniques for document preparation and regulatory submission.
Assist program managers in project planning, timelines, budgeting, and contract management as needed.
Represent the medical writing team at project launch meetings, review meetings, and cross-functional project discussions.
Qualifications & Experience:
Bachelor’s degree in a scientific discipline (advanced degree preferred).
5+ years of relevant medical writing experience in the pharmaceutical/CRO industry.
Proven experience in authoring, reviewing, and editing clinical and regulatory documents.
Additional medical writing certifications (AMWA, EMWA, RAC) are advantageous.
Skills & Competencies:
Exceptional medical writing, data interpretation, and editorial skills.
Strong project management and organizational capabilities.
Excellent communication, presentation, and interpersonal skills.
Expertise in global, regional, and national document development guidelines.
In-depth knowledge of therapeutic areas, preclinical studies, regulatory submissions, and clinical communications.
Proficiency in document management systems and standard office applications (e.g., MS Excel, Outlook).
Sound judgment, problem-solving abilities, and independent decision-making skills.
Why Join Us:
Work remotely with a globally recognized CRO and advance your medical writing career.
Lead scientific documentation that supports regulatory submissions and clinical research excellence.
Collaborate with multidisciplinary teams across clinical, regulatory, and operational functions.
Mentor junior writers and contribute to process improvements and best practices.
Equal Opportunity Employer:
Thermo Fisher Scientific is committed to diversity, equity, and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected status.
Apply Today: Advance your career as a Senior Medical Writer and contribute to global clinical research and regulatory excellence.
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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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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kfar Saba | Yavne | Be'Er Sheva | Tel Aviv | Netanya |Remote :
Ireland | McFarland | Faridabad | Remote, USA | Minnesota | Remote | Thailand | Zaragoza | Remote - Middle East | Texas | Victoria | Belgium | Xzagreb | Medan | Melbourne | Nairobi | Hammond | Lenexa | Remote - Africa | Remote - South America (Latin Americal) | Green Way | Bountiful | Bishop | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Hungary | Springville | Manipal | French | Switzerland | Tulsa | Lousiana | Riga | Slovakia | Leinster | Castlebar |Republic of Colombia :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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