Medical Writer Operation Lead


Penfield Search Partners

Contact: Alexandra Spink –

Job Responsibilities:

  • Process, maintain, and lead the SOP/WI/JA update with MW SMEs and cross-functional input
  • Collect feedback and perform GAP analysis activities and implement actions
  • Establish and support implementation of best practices
  • Support CAPA and quality event management
  • Standardization and Maintenance Document Development
  • Template library update (ex. Protocol, CSR, IB, DSUR, M2 docs, BB, PIP etc.)
  • Lexicons, company style guide, reference libraries
  • Inspection Readiness: System, Content, Quality, and TMF Review
  • Review record keeping and filing activities to improve inspection-readiness
  • Partnering with internal and cross-functional stakeholders for inspection readiness
  • System and Technologies
  • Collaborate with IT and MW SMEs to test and implement new systems (ex. AI, automation)
  • Metrics and Performance Tracking (Internal and Vendors)

Tagged as: Medical Writer Operation Lead