Senior Medical Writer, Principal Medical Writer

Precision For Medicine

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

Posted 9/30/2026full-timeRemote • HungarySenior💰 $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, ensuring compliance with regulatory guidelines and internal standards. Proficient in managing document workflows and communicating effectively with internal and external stakeholders.

Highest-signal resume keywords

Clinical Study Document DevelopmentRegulatory Compliance (ICH, FDA, GCP)Medical Writing Process ManagementProficiency in Microsoft Office SuiteOncology and Rare Disease Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Protocol WritingInformed Consent Form (ICF) DevelopmentClinical Study Report (CSR) AuthoringDocument Quality Control (QC) ReviewLiterature-Based Research

Soft Skills

Attention to DetailEffective CommunicationAbility to Work in Fast-Paced Environment

Tools & Technologies

Microsoft WindowsMicrosoft TeamsMicrosoft WordMicrosoft ExcelAdobe AcrobatMicrosoft PowerPoint

Industry Keywords

ECTD RequirementsClinical Trial Transparency (EudraCT, CT.gov)SOP DevelopmentMedical Writing Templates

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 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 process understanding
Communicate clearly and concisely in writing and verbally 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 (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
Advanced degree (MS/PhD) preferred
Oncology and/or rare disease experience, especially protocol and CSR development, preferred
Candidates must be legally authorized to work in the country of employment without employer sponsorship