Senior Medical Writer/Principal Medical Writer

Position Summary The Senior Medical Writer / Principal Medical Writer will lead the development of high‑quality, on‑time clinical study documents. Responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Documents are developed in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ICH, FDA, GCP) and eCTD requirements. The candidate must have a clear understanding of content requirements for key clinical documents across all development phases and deliver MW activities with impeccable attention to detail. Essential Functions Planning, writing, editing, formatting, and QC review of timely and high‑quality clinical documents including clinical study protocols, Investigational Brochures (IBs), Informed Consent Form (ICF) templates, DSURs, Clinical Study Reports (CSRs) and CSR patient narratives, applying regulatory guidance. Ensuring smooth and effective document management from template to final approved version in collaboration with sponsors, external vendors, and internal Precision project teams. Formulating key messages from clinical study data independently. Authoring complex content using knowledge of processes and medical terminology. Communicating clearly and concisely in writing and verbally with internal and client teams. Contributing to the development and maintenance of medical‑writing processes, SOPs, templates, and work instructions for key documents. Exhibiting excellent problem‑solving skills. Conducting literature‑based research to support writing activities. Qualifications BS degree or equivalent in a scientific or medical discipline with relevant writing expertise. 5+ years of experience as a Senior Medical Writer in a sponsor and/or CRO setting or 7+ years of experience as a Principal Medical Writer. Other Requirements Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint. Clear understanding of applicable regulations (ICH, FDA, GCP), clinical trial transparency requirements (EudraCT, ClinicalTrials.gov), and eCTD requirements for all development phases. Impeccable attention to detail and ability to complete assignments in a timely manner. Ability to work effectively in a fast‑paced environment with multiple high‑priority projects and minimal instruction on new assignments. Preferred Qualifications Advanced degree (MS/PhD). Experience in oncology and/or rare disease, especially protocol and CSR development. Compensation & Benefits The compensation range for this role is $100,600 – $182,600 USD, plus discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, paid sick leave, and vacation. Equal Opportunity Employment Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law. Legal & Privacy Information Any data provided as part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Recruitment Fraud Warning Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you are concerned about a potential scam, report to local law enforcement, consumer protection agency, or relevant cybercrime organization. Contact us at View email address on click.appcast.io to report any concerns. #J-18808-Ljbffr