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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Medical Writing, including the preparation and quality assurance of regulatory documents such as PSURs, PBRERs, and Risk Management Plans. Proven ability to collaborate with cross-functional teams and mentor junior writers while ensuring compliance and scientific accuracy.
Highest-signal resume keywords
Medical WritingRegulatory CompliancePharmacovigilanceTeam CollaborationMentoring
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 WritingRegulatory DocumentsPharmacovigilanceCase ProcessingSignal DetectionRisk ManagementQuality AssuranceData AnalysisScientific AccuracyProcess Improvement
Soft Skills
Attention to DetailStrong Team PlayerEffective CommunicationMentoring AbilityClient Relationship Management
Industry Keywords
CRO EnvironmentLife Science DegreeMDPharmacy DegreeMaster's DegreePhDFluency in EnglishAdditional Language
About the role
Key responsibilities & impact- Author, review, and quality check regulatory and pharmacovigilance documents, including PSURs/PBRERs, PADERs, ACOs, DSURs, and Risk Management Plans
- Ensure documents are scientifically accurate, regulatory compliant, and delivered within agreed timelines
- Collaborate with cross-functional teams to analyze, interpret, and present safety data
- Act as a trusted client contact, supporting project delivery and fostering strong working relationships
- Guide, mentor, and share knowledge with junior medical writers
- Contribute to process improvements and enhancement of medical writing quality standards
Requirements
What you’ll need- MD, pharmacy, or Life Science degree
- Minimum 2 years' experience in Medical Writing and associated fields, including case processing, signal detection, or risk management
- Experience ideally within a CRO environment
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Ability to effectively train and mentor Associate Medical Writers
- Strong team player
- Fluency in English
- Additional language is beneficial
- Master's or PhD is desirable
Benefits
Comp & perks- Remote work option
- Flexible work environment
- Growth and professional development opportunities
- Mentoring and knowledge-sharing opportunities
- Collaborative team environment
- Opportunity to contribute to process improvements
- Opportunity to work on global pharmacovigilance and clinical research projects