Senior Medical Writer / Principal Medical Writer

Precision For Medicine

. 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

Use this summary to align your resume positioning with the role.

Demonstrates expertise in medical writing, including the development of clinical study documents in compliance with regulatory guidelines and internal SOPs. Proficient in managing document workflows and communicating effectively with cross-functional teams.

Highest-signal resume keywords

Clinical Study Document DevelopmentRegulatory Compliance (ICH, FDA, GCP)ECTD Requirements UnderstandingMicrosoft Office ProficiencyMedical Writing Process Development

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Study ProtocolsIBsICF TemplatesDSURsCSRsCSR Patient NarrativesLiterature-Based ResearchAttention to DetailWriting ExpertiseDocument Management

Soft Skills

Clear CommunicationTime ManagementCollaborationAdaptabilityAttention to Detail

Tools & Technologies

Microsoft WindowsMicrosoft TeamsMicrosoft WordMicrosoft ExcelAdobe AcrobatMicrosoft PowerPoint

Industry Keywords

Clinical Trial TransparencyEudraCTCT.govPrecision MW Style GuideSOPs

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, applicable regulatory guidelines, and eCTD requirements
Ensure smooth and effective document management 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 process understanding
Communicate clearly and concisely with internal and client teams
Contribute to developing and maintaining 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