Senior Medical Writer/Principal Medical Writer

Position Summary:

The Senior Medical Writer/Principal Medical Writer 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.

Essential functions of the job include but are not limited to:

• 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 guidance's
• 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

Qualifications:

Minimum Required:

• 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.

Other Required:

• 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

Preferred:

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

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Originally posted on Himalayas