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Senior Medical Writer/Principal Medical Writer
Precision Medicine Group. Lead the development of high-quality and on-time clinical study documents .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing high-quality clinical study documents in compliance with regulatory guidelines, including ICH, FDA, and GCP. Proficient in managing document workflows and collaborating with internal and external teams to ensure timely completion of writing assignments.
Highest-signal resume keywords
Clinical Study Document DevelopmentRegulatory Compliance (ICH, FDA, GCP)Medical Writing ExpertiseDocument ManagementProficiency in Microsoft Office Suite
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study ProtocolsInvestigator Brochures (IBs)Informed Consent Forms (ICFs)Development Safety Update Reports (DSURs)Clinical Study Reports (CSRs)Patient NarrativesLiterature-Based ResearchQuality Control (QC) ReviewContent AuthoringDocument Formatting
Soft Skills
Attention to DetailEffective CommunicationAbility to Work in Fast-Paced EnvironmentTime ManagementCollaboration
Tools & Technologies
Microsoft WindowsMicrosoft TeamsMicrosoft WordMicrosoft ExcelAdobe AcrobatMicrosoft PowerPoint
Industry Keywords
Clinical Trial TransparencyECTD RequirementsSOPsMedical Writing ProcessesSponsor and CRO Experience
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the development of high-quality and on-time clinical study documents
- Plan, write, edit, format, and perform QC review of clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives
- Develop documents in compliance with the Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ICH, FDA, GCP), and eCTD requirements
- Manage documents from template through final approved version in collaboration with sponsors, external vendors, and internal Precision project teams/departments
- Independently formulate key messages from clinical study data
- Author complex content using knowledge, skills, and understanding of processes
- Communicate clearly and concisely with internal and client teams
- Contribute to medical writing processes, SOPs, templates, and work instructions
- Perform literature-based research to support writing activities
- Perform other duties as assigned
Requirements
What you’ll need- BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
- 5+ years of experience as a Sr. Medical Writer in the sponsor and/or CRO setting, or 7+ years of experience as a Principal Medical Writer
- Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
- Clear understanding of applicable regulations (e.g., ICH, FDA, GCP), clinical trial transparency requirements (EudraCT, CT.gov), and eCTD requirements for all phases of development
- Impeccable attention to detail and ability to complete writing assignments in a timely manner
- Ability to work effectively in a fast-paced environment with multiple high-priority projects with no instruction on routine work and minimal instruction on new assignments