FSP Medical Writer – Regulatory
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: United Kingdom
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About the role
- Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
- Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies
- May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
- Ensure compliance with quality processes and requirements for assigned documents
- May assist in determining best practices, methods and techniques for achieving optimal results
- May assist in program management activities; Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables
- Represent the department at project launch meetings, review meetings, and project team meetings
Requirements
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Experience working in the pharmaceutical/CRO industry preferred
- Experience in scientific writing advantageous
- Solid medical writing skills, including grammatical, editorial, and proofreading skills
- Ability to interpret and present complex data accurately and concisely
- Effective administrative, organizational and planning skills; attention to detail and quality
- Ability to work on own initiative and effectively within a team
- Effective oral and written communication skills
- Good knowledge of regulatory documentation and drug development process
- Great judgment and decision-making skills
- Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Benefits
- Competitive salary
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingscientific writingclinical study reportsstudy protocolsregulatory documentationdata interpretationproofreadingeditorial skillsprogram managementbudget forecasting
Soft Skills
attention to detailorganizational skillsplanning skillseffective communicationteamworkinitiativejudgmentdecision-makingadministrative skillsquality assurance