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Senior Medical Editor – QC, Regulatory Editing
Syneos Health. Maintain familiarity with FDA, EU, and other relevant guidelines and industry standards .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing and copyediting, with a strong understanding of FDA and EU guidelines, ICH regulations, and ISO standards. Proven ability to manage projects effectively while ensuring high-quality deliverables and adherence to timelines and budgets.
Highest-signal resume keywords
Medical WritingCopyeditingProject ManagementFDA GuidelinesQuality Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CopyeditingQuality ReviewProject ManagementMedical WritingAttention to Detail
Soft Skills
Interpersonal SkillsOrganizational SkillsProblem SolvingPresentation SkillsTeam-Oriented
Tools & Technologies
Microsoft Office SuiteAMA Manual of Style
Industry Keywords
PharmaceuticalMedical DeviceContract Research OrganizationICH RegulationsISO Standards
About the role
Key responsibilities & impact- Maintain familiarity with FDA, EU, and other relevant guidelines and industry standards
- Represent the editorial group in medical writing, study teams, and cross-departmental project teams
- Monitor timelines and budgets for assigned projects and report risks to relevant stakeholders
- Provide technical support and expertise
- Train and mentor medical editing staff
- Advise medical writers, medical editors, and study teams on quality review, compilation, and editorial standards
- Serve as project lead for complex and/or large medical writing deliverables
- Schedule and lead project-specific team meetings
- Organize project-specific requirements and ensure information is distributed and implemented
- Serve as a member of the medical writing team and provide feedback on editorial progress
- Copyedit assigned documents according to AMA Manual of Style, custom style guidelines, internal checklists, and best practices
- Perform quality review of assigned documents for accuracy
- Contribute to process improvement tools and internal editorial policies and procedures
- Manage assigned projects according to medical writing procedures and client standards, on time and on budget
- Compile medical writing deliverables as needed
Requirements
What you’ll need- 4 Year/Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or relevant copyediting and/or quality review experience
- 3-5 years of copyediting experience
- Pharmaceutical, medical device, or contract research organization experience preferred
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
- Excellent attention to detail
- Strong copyediting, quality review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills
- Knowledge of FDA and EU requirements, ICH regulations, and ISO standards as applicable to regulatory documents required
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate