Senior Regulatory Medical Writer, Client-Embedded, FSP

🔥 13 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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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

• 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, including IBs, bioassay reports, INDs, and MAAs • Collaborate with cross-functional teams and internal and external clients 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 oversee junior medical writers • Assist the program manager as needed • Stay current with industry trends, guidelines, and regulatory requirements

🎯 Requirements

• Bachelor's degree in a scientific discipline or equivalent relevant formal academic/vocational qualification • Advanced degree preferred • 5+ years of previous experience providing relevant knowledge, skills, and abilities • Experience working in the pharmaceutical/CRO industry preferred • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous • Proven track record authoring clinical regulatory documents • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills • Strong project management skills • Excellent interpersonal, problem-solving, negotiation, oral, written communication, and presentation skills • Significant knowledge of global, regional, national, and other document development guidelines • Excellent computer skills and proficiency with client templates • Good knowledge of document management systems and relevant applications such as Excel and Outlook • Ability to meet requirements through an equivalency of appropriate education, training, and/or directly related experience may be considered

🏖️ Benefits

• Award-winning learning and development program • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and develop professionally and personally