Senior Specialist, Medical Writing & Quality Control

Role Summary

Senior Specialist, Medical Writing & Quality Control responsible for conducting QC reviews of clinical and regulatory documents, reports, data tables, and slide presentations in support of drug development, and assisting with oversight of QC projects assigned to contractors and CROs. Also supports medical writing activities with supervision.

Responsibilities

• Perform comprehensive QC reviews of clinical and regulatory documents, reports, data tables, and slide presentations within predefined timelines.
• Edit documents for grammar, punctuation, consistency, and adherence to internal style guides and regulatory requirements.
• Collaborate with medical writers, regulatory affairs, and cross-functional teams to resolve discrepancies and ensure document quality.
• Organize complex QC projects and provide guidance to other QC reviewers.
• Support authoring process for plain language documents, including informed consent forms and plain language protocol synopses.
• Assist in maintaining and updating the Crinetics Style Guide.
• Support medical writing activities with supervision as needed.
• Manage changing priorities across multiple projects in a dynamic environment.
• Complete other tasks as assigned.

Qualifications

• Required:
  • Bachelor‚Äôs or Master‚Äôs degree in a scientific discipline; advanced life sciences degree preferred.
  • Minimum of 5 years‚Äô experience conducting QC data reviews and editing; experience with regulatory documents for biotech/pharmaceutical industry preferred.
  • Expert attention to detail; highly organized and methodical work style.
  • Familiarity with electronic document control and management systems.
  • Experience with regulatory submissions (IND, NDA, MAA, NDS, etc) in eCTD format preferred.
  • Excellent written and spoken English.
• Preferred:
  • Ability to manage multiple projects and adapt to changing priorities.
  • Time- and task-management focused; adheres to timelines and deliverables.
  • Proficiency in MS Word (templates and style guides); familiarity with Excel and PowerPoint.
  • Experience authoring plain language documents.
  • Team-oriented with strong communication and interpersonal skills; ability to manage indirectly.

Skills

• Quality control and editing of clinical/regulatory documents
• Regulatory writing and submissions (eCTD)
• Plain language document authoring
• Document management systems
• Cross-functional collaboration
• Project organization and supervision of QC teams

Education

• Bachelor‚Äôs or Master‚Äôs degree in a scientific discipline; advanced life sciences degree preferred.

Additional Requirements

• Travel up to 5% may be required.
• Physical demands relate to standard office work; no unusual requirements noted beyond typical laboratory environment if applicable.