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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory and pharmacovigilance writing, ensuring scientific accuracy and compliance in documents such as PSURs and Risk Management Plans. Proven ability to mentor junior medical writers and collaborate effectively with cross-functional teams to enhance medical writing quality standards.
Highest-signal resume keywords
Medical WritingRegulatory CompliancePharmacovigilanceMentoringClient-Focused Mindset
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory WritingPharmacovigilance DocumentationPSURsPBRERsPADERsACOsDSURsRisk Management PlansSignal DetectionCase Processing
Soft Skills
Attention to DetailTeam-Player SkillsCollaborationCommunicationMentoring
Industry Keywords
CRO EnvironmentLife Science DegreeMDPharmacy DegreeProfessional Growth
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 analyse, interpret, and present safety data
- Act as a trusted point of contact for clients and support project delivery
- Foster strong working relationships with clients
- Provide guidance, mentoring, and knowledge sharing to junior medical writers
- Support professional growth and development of Associate 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), 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 skills
- Fluency in English
- Additional language is a benefit
- Experience with regulatory and pharmacovigilance writing
- Client-focused mindset and attention to detail
Benefits
Comp & perks- Remote work option
- Professional growth and development opportunities
- Mentoring and knowledge-sharing opportunities
- Collaborative and supportive work environment
- Flexible work culture
- Belonging and inclusive workplace culture
- Opportunity to contribute to patient safety and global pharmaceutical work