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Medical Writer
Thermo Fisher Scientific. Serve as primary author for routine documents such as 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 and regulatory documentation, with strong skills in summarizing complex data and ensuring compliance with quality processes. Proficient in project management activities, including timeline and budget development, while maintaining effective communication with internal and external stakeholders.
Highest-signal resume keywords
Clinical WritingRegulatory DocumentationProject ManagementData InterpretationPharmaceutical Industry Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical WritingGrammatical SkillsEditorial SkillsProofreading SkillsData SummarizationQuality ComplianceDocument Management SystemsBudget DevelopmentTimeline DevelopmentForecasting
Soft Skills
Attention to DetailOrganizational SkillsEffective CommunicationJudgment SkillsTeam Collaboration
Tools & Technologies
ExcelOutlookClient Templates
Industry Keywords
PharmaceuticalCROClinical Study ReportsStudy ProtocolsINDsMAAsQuality ProcessesScientific WritingDrug Development Process
About the role
Key responsibilities & impact- Serve as primary author for routine documents such as 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 in determining best practices, methods, and techniques for optimal results
- Assist with program management activities, including developing timelines, budgets, and forecasts for assigned deliverables
- Represent the department at project launch, review, and project team meetings
- Collaborate with internal and external clients to support effective communication and operational excellence
Requirements
What you’ll need- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job
- 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 proficiency with client templates
- Good knowledge of document management systems and relevant applications such as Excel and Outlook
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Commitment to scientific excellence
- Occasional domestic and international travel