Senior Medical Writer/Principal Medical Writer
Position Summary
The Senior Medical Writer/Principal Medical Writer will lead the development of high-quality and on-time clinical study documents. Responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Duties must comply with Precision MW Style Guide, Precision SOPs, regulatory guidelines (ICH, FDA, GCP), and eCTD requirements.
Essential Functions
- Planning, writing, editing, formatting, and QC review of clinical documents such as clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives
- Ensuring smooth document management from start to finish, collaborating with Sponsor, external vendors, and/or internal Precision project teams/departments
- Formulating key messages from clinical study data
- Authoring complex content using knowledge/skills and understanding of processes
- 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
- Performing literature-based research to support writing activities
Qualifications
- Minimum Required: BS degree or equivalent in a scientific or medical discipline with relevant writing expertise; 5+ years of experience as a medical writer in the sponsor and/or CRO setting or 7+ years of experience as a Principal Medical Writer
- Other Required: 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
- Preferred: Advanced degree (MS/PhD); Oncology and/or rare disease experience (especially protocol and CSR development)
Reasonable Estimate of the Current Range
$100,600 - $182,600 USD
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Equal Opportunity Employer
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.
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