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Principal Medical Writer
Thermo Fisher Scientific. Research, write, and edit routine documents including clinical study reports and study protocols .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical writing, including the preparation of clinical study reports and protocols, while ensuring compliance with regulatory documentation and quality processes. Possesses strong organizational, communication, and analytical skills to effectively manage project timelines and collaborate with diverse teams.
Highest-signal resume keywords
Clinical WritingRegulatory DocumentationProject ManagementData InterpretationCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Scientific WritingMedical WritingProofreadingData SummarizationDocument Editing
Soft Skills
Attention to DetailOrganizational SkillsTeam CollaborationInitiativeDecision-Making
Tools & Technologies
Document Management SystemsExcelOutlook
Industry Keywords
Pharmaceutical IndustryCROClinical StudiesDrug Development Process
About the role
Key responsibilities & impact- Research, write, and edit routine documents including clinical study reports and study protocols
- Summarize data from clinical studies
- Assist with complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs
- Ensure compliance with quality processes and requirements for assigned documents
- Assist with program management activities, including developing timelines, budgets, and forecasts
- Participate in project launch meetings, review meetings, and project team meetings
- Collaborate with internal and external clients to support effective and efficient communication
- Deliver high-quality medical and scientific writing from planning and coordination through final drafts
Requirements
What you’ll need- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
- Experience working in the pharmaceutical/CRO industry advantageous
- Experience in scientific writing advantageous
- Basic 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
- Basic knowledge of regulatory documentation and drug development process
- Good judgment and decision-making
- Competent computer skills and use of templates; basic knowledge of document management systems and relevant applications such as Excel and Outlook
- Willingness and ability to occasionally drive to site locations and travel domestically and internationally
- Ability to work occasional long, varied hours
Benefits
Comp & perks- Fully Remote work arrangement
- Standard Monday-Friday work schedule
- Collaboration and development opportunities
- Global team environment
- Occasional international and domestic travel