Senior Medical Writer

Precision for Medicine

9h

About The Position

The Senior Medical Writer (MW) will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.

Requirements

• 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
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
• Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, 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

Nice To Haves

• Advanced degree (MS/PhD)
• Oncology and/or rare disease experience (especially protocol and CSR development)

Responsibilities

• Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidances
• Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments
• Ability to independently formulate key messages from clinical study data
• Ability to author complex content using knowledge/skills and understanding of processes
• Ability to communicate clearly and concisely both in writing and verbally with internal and client teams
• Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
• Excellent problem-solving skills
• Performing literature-based research to support writing activities
• Other duties as assigned

Benefits

• discretionary annual bonus
• health insurance
• retirement savings benefits
• life insurance
• disability benefits
• parental leave
• paid time off for sick leave and vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 101-250 employees