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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 documentation, and compliance with ICH guidelines. Proficient in analyzing and presenting scientific data while collaborating effectively with cross-functional teams.
Highest-signal resume keywords
Medical Writing ExperienceRegulatory DocumentationICH Guidelines KnowledgeMicrosoft Office Suite 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 DocumentationStatistical AnalysisScientific InterpretationDocument Preparation
Soft Skills
Attention to DetailInterpersonal SkillsCommunication Skills
Tools & Technologies
Microsoft Office SuiteMicrosoft Word
Industry Keywords
Contract Research OrganizationPharmaceutical ResearchBiotechnology ResearchRegulatory Guidelines
About the role
Key responsibilities & impact- Independently plan and prepare a range of regulatory documents and medical communications supporting all phases of product development.
- Organize, analyze, interpret, and present scientific and statistical information in accordance with ICH and 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 7 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, as determined on a case-by-case basis.
- 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 is essential, including advanced Microsoft Word proficiency.
Benefits
Comp & perks- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
