Director, Medical Writing

Company: Recursion
Location: Salt Lake City
Posted on: May 26, 2023

Job Description:

The Impact You'll Make
You will be the lead Medical Writer on one or more development programs, providing both hands-on support as well as cross-functional leadership. You will also manage consultant medical writers and develop relevant Medical Writing processes. You'll collaborate within and across departments to agree on the most important program resourcing needs, challenges and capabilities, then figure out how to get us there.

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• Create, edit, and coordinate production of high-quality and timely regulatory and scientific deliverables that support multiple clinical programs covering all phases of clinical research within various therapeutic areas. Develop and maintain SOPs, style guides, and a quality control checklist.
  
• Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities; perform quality/peer reviews on documents developed by other writers. Act as subject matter expert for the development of data transparency deliverables.
  
• Communicate document deliverables needed, writing processes, and timelines to team members; negotiate with functional areas on project outcomes and deliverables to meet conflicting demands. Communicate pertinent FDA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production.
  
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
  
• Lead or contribute to improvement projects related to medical writing processes, standards, and initiatives. Lead contract medical writers and ensure that projects are appropriately resourced.
  
• Adhere to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs and templates.
  
  Location:
  Making Salt Lake City your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to quarterly visits for routine work and departmental events.
  The Team You'll Join
  The Clinical Development Team is an empowered, execution-minded group of professionals responsible for translating Recursion's innovative science to patients. As the Director, Medical Writing, you will be an integral member of the Recursion Clinical Development Team. Reporting to the Senior Director Clinical Development, you'll collaborate with your teammates and across departments to deliver a wide array of documents that support the expanding Recursion portfolio.
  The Experience You'll Need
  
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  • 5+ years of medical writing experience preparing regulatory documents in the pharmaceutical and/or biotech industry with at least 3 years as a medical writing project lead.
    
  • Ability to prepare any type of clinical regulatory document (eg, protocol, CSR, IB, clinical sections of IND, CTD) according to company guidelines and international governmental regulations.
    
  • Demonstrated understanding of clinical research, the drug development process, and US and international guidelines and regulations, eg, ICH-GCP.
    
  • Ability to simultaneously manage multiple medical writing deliverables with aggressive timelines, balancing and prioritizing multiple parallel work streams to meet project goals; flexible and does best work in an energizing environment; embraces new technology to meet business needs.
    
  • Ability to work with cross-functional teams to complete medical writing deliverables within predefined timelines.
    
  • Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs
    
    How You'll be Supported
    
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    • Regular 1:1s with your supervisor provides opportunities for support and feedback.
      
    • Transition and resourcing plan
      
    • Membership to medical writing or Regulatory organization (AMWA, EMWA, DIA Medical Writing, RAPS)
      
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Keywords: Recursion, Salt Lake City , Director, Medical Writing, Executive , Salt Lake City, Utah