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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 CompliancePharmacovigilanceMentoringCross-Functional Collaboration
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 Document PreparationPharmacovigilance DocumentationRisk Management PlansSafety Data AnalysisCase ProcessingSignal DetectionAttention to DetailProject DeliveryProcess Improvement
Soft Skills
Team PlayerMentoringClient Relationship ManagementCommunication
Industry Keywords
CRO EnvironmentLife Science DegreeMDPharmacy DegreeFluency 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 (RMPs)
- Ensure documents are scientifically accurate, regulatory compliant, and delivered within agreed timelines
- Collaborate with cross-functional teams to analyse, interpret, and present safety data
- Act as a trusted client point of contact, supporting project delivery and fostering working relationships
- Provide guidance, mentoring, and knowledge sharing to 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 (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 a benefit
- 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
- Belonging-focused workplace culture