Senior Regulatory Medical Writer, Client-embedded

🔥 9 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.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

🧬 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

• Serve as a primary author for routine clinical documents such as clinical study reports and study protocols • Summarize data from clinical studies • Author complex clinical, scientific, and program-level documents such as IBs, bioassay reports, INDs, and MAAs • Collaborate with cross-functional teams to gather information and ensure document accuracy and completeness • Ensure documents align with regulatory guidelines, company standards, and industry best practices • Provide input on document content, structure, and presentation • Review and provide feedback on documents prepared by other team members • Manage timelines and deliverables for assigned projects • Mentor and provide oversight to junior medical writers • Stay current with industry trends, guidelines, and regulatory requirements • Potentially assist the program manager • Provide medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients

🎯 Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Experience working in the pharmaceutical/CRO industry preferred • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous • Excellent data interpretation and medical writing skills • Grammatical, editorial, and proofreading skills • Strong project management skills • Excellent interpersonal and problem-solving skills • Strong negotiation skills • Excellent oral and written communication skills • Strong presentation skills • Significant knowledge of global, regional, national, and other document development guidelines • Great judgment and decision-making skills • Excellent computer skills • Skilled with client templates • Good knowledge of document management systems and relevant applications such as Excel and Outlook

🏖️ Benefits

• Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Award-winning learning and development program • Collaborative environment • Professional and personal growth opportunities

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