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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, regulatory document preparation, and compliance with ICH guidelines. Strong ability to analyze and present scientific information while collaborating effectively with cross-functional teams.
Highest-signal resume keywords
Medical Writing ExperienceRegulatory Document PreparationICH Guidelines KnowledgeMicrosoft Word ProficiencyInterpersonal Communication Skills
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 ComplianceScientific AnalysisStatistical InterpretationDocument Organization
Soft Skills
Attention to DetailCommunication SkillsCollaboration
Tools & Technologies
Microsoft Office Suite
Industry Keywords
Contract Research OrganizationPharmaceutical ResearchBiotechnology Research
About the role
Key responsibilities & impact- Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
- Organize, analyze, interpret, and present scientific and statistical information
- Ensure documents comply with ICH, other regulatory guidelines, and company document standards
- Work under the direction of Medical Writing management
- Collaborate with cross-functional internal and external document production teams
Requirements
What you’ll need- Bachelor’s degree required; science-related field preferred
- Minimum of 5 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting
- Other professional and/or educational experience may contribute toward this minimum requirement on a case-by-case basis
- Minimum of 3 years of formal medical writing experience required
- Advanced knowledge of ICH and related regulatory guidelines
- Excellent written English and keen attention to detail
- Strong interpersonal and communication skills
- Experience with Microsoft Office Suite, including advanced Microsoft Word proficiency
Benefits
Comp & perks- Fully remote work arrangement
- Flexible, inclusive culture
- Equal opportunity and inclusive environment
