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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory document preparation and medical communications, with a strong focus on ICH guidelines and advanced proficiency in Microsoft Word. Capable of analyzing and presenting scientific information while collaborating effectively with cross-functional teams.
Highest-signal resume keywords
Medical Writing ExperienceRegulatory Document PreparationAdvanced ICH 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
Regulatory Document PreparationMedical WritingStatistical AnalysisScientific InterpretationAttention to Detail
Soft Skills
Interpersonal SkillsCommunication Skills
Tools & Technologies
Microsoft Office SuiteMicrosoft Word
Industry Keywords
Contract Research OrganizationPharmaceutical ResearchBiotechnology ResearchICH Guidelines
About the role
Key responsibilities & impact- The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
- Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards.
- Works under the direction of Medical Writing management and collaborates 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.
- 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
