[Hiring] Senior Medical Writer/Principal Medical Writer @Precision for Medicine

Role Description

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:

• 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.
• Ensuring smooth and effective document management from start to finish in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments.
• Independently formulating key messages from clinical study data.
• Authoring complex content using knowledge/skills and understanding of processes.
• Communicating clearly and concisely both 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.
• 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).

Company Description