Senior Medical Writer/Principal Medical Writer

Precision Medicine Group

. Lead the development of high-quality and on-time clinical study documents .

Posted 9/30/2026full-timeRemote • SerbiaSenior💰 $100,600 - $182,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including the development of clinical study documents in compliance with ICH, FDA, and GCP regulations. Proficient in document management and communication with internal and external stakeholders to ensure high-quality deliverables.

Highest-signal resume keywords

Medical Writing ExpertiseClinical Study Document DevelopmentRegulatory Compliance (ICH, FDA, GCP)Document ManagementProficiency in Microsoft Office Suite

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProtocolsIBsICF TemplatesDSURsCSRsCSR Patient NarrativesLiterature-Based ResearchECTD RequirementsAttention to DetailWriting Assignments

Soft Skills

Effective CommunicationAbility to Work in Fast-Paced EnvironmentTime Management

Tools & Technologies

Microsoft WindowsMicrosoft TeamsMicrosoft WordMicrosoft ExcelAdobe AcrobatMicrosoft PowerPoint

Industry Keywords

Clinical Trial TransparencyEudraCTCT.govPrecision MW Style GuidePrecision SOPs

Tech Stack

Tools & technologies

Google 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 Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD requirements
Formulate key messages from clinical study data independently
Author complex content using knowledge of relevant processes
Communicate with internal and client teams
Ensure effective document management from template through final approved version in collaboration with sponsors, external vendors, and internal Precision teams/departments
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, including ICH, FDA, and GCP
Understanding of clinical trial transparency requirements, including EudraCT and CT.gov
Understanding of 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