Senior Medical Writer- Clinical Focus

Position Specific Overview

The Senior Medical Writer- Clinical Focus is a major contributor to document authorship for a variety of documents across different service lines. The Sr Medical Writer will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team.

What We Offer

• Estimated hiring range: $116K to $128K plus applicable bonus

• Benefits vary by location and may include:

  • Remote working
  • Flexible time off
  • Paid holidays
  • Medical insurance
  • Tuition reimbursement
  • Retail plans

What We Look For

• Education, Experience, Training, and Knowledge:

  • Bachelor’s degree
  • 3+ years of regulatory writing experience or equivalent experience with clinical related documentation
  • Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
  • Experience in the development of submission-level documents (does not require functioning as a document lead)
  • Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE

• Skills & Abilities:

  • Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
  • Strong understanding of the document creation process and of the drug development lifecycle
  • Able to synthesize data across multiple data sources and documents to create summary reports
  • Able to conduct/lead a CRM and successfully lead a project team to consensus
  • Able to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others
  • Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
  • Able to identify and institutionalize work practices that are most effective in order to ensure consistency in performance

Automated Decision Making

All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.