Senior Medical Writer/Principal Medical Writer

Precision Medicine Group

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

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing high-quality clinical study documents in compliance with regulatory standards, including ICH, FDA, and GCP. Proficient in managing document workflows and communicating effectively with internal and external stakeholders.

Highest-signal resume keywords

Senior Medical Writer ExperienceClinical Study Document DevelopmentRegulatory Compliance KnowledgeMicrosoft Office ProficiencyAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProtocolsIBsICF TemplatesDSURsCSRsCSR Patient NarrativesLiterature-Based ResearchDocument ManagementMedical Writing ProcessesECTD Requirements

Soft Skills

Clear CommunicationTime ManagementAbility to Work IndependentlyAdaptability in Fast-Paced Environments

Tools & Technologies

Microsoft WindowsMicrosoft TeamsMicrosoft WordMicrosoft ExcelAdobe AcrobatMicrosoft PowerPoint

Industry Keywords

Oncology ExperienceRare Disease ExperienceClinical Trial Transparency RequirementsSOPsPrecision MW Style Guide

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the development of high-quality, on-time clinical study documents
Plan, write, edit, format, and perform QC review of 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
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 relevant knowledge, skills, and process understanding
Communicate clearly and concisely with internal and client teams, in writing and verbally
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 Senior 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
Candidates must be legally authorized to work in the country of employment without employer sponsorship
Advanced degree (MS/PhD) preferred
Oncology and/or rare disease experience preferred