• Job Description

  Req#: 11ba4501-6920-4ad1-8a34-9c66060bd618
  Employer Industry: Biopharmaceuticals
  
  Why consider this job opportunity:
  - Hourly pay range of $70/hr - $80/hr
  - Opportunity for career advancement and growth within the organization
  - Remote work flexibility with occasional travel to the Bay Area for key meetings
  - Be at the forefront of cell therapy innovation and contribute to transformative treatments for autoimmune diseases
  - Supportive and collaborative work environment with a focus on operational excellence
  
  What to Expect (Job Responsibilities):
  - Support the development of the Investigator’s Brochure SOP and associated templates, including internal guidance documents and process aids
  - Coordinate and track CSR appendices in partnership with cross-functional teams
  - Oversee document review coordination, including preparing and aligning reviewer rosters
  - Coordinate QC activities for clinical and regulatory documents, ensuring timelines and deliverables are met
  - Develop and maintain document trackers for version history, ownership, and approvals to support audit readiness
  
  What is Required (Qualifications):
  - 7+ years in medical or regulatory writing operations within a GxP environment
  - Hands-on SOP authorship and routing experience, ideally with DOT or similar systems
  - Strong coordination and document control experience across review cycles, including experience with Veeva or similar regulatory document management systems
  - Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines
  - Strong interpersonal and communication skills with proven ability to build trust across cross-functional teams
  
  How to Stand Out (Preferred Qualifications):
  - Experience coordinating CSR appendices and other cross-functional components of BLA submissions (e.g., Module 2 and 5 deliverables)
  - Exposure to regulatory submissions (INDs, BLAs, CTDs)
  - Familiarity with CAPA documentation and inspection-readiness processes, including Medical Writing’s role in supporting inspection responses
  
  #Biopharmaceuticals #MedicalWriting #RemoteWork #CareerOpportunity #RegulatorySubmissions
  
  "We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."

• About the company

  Kyverna Technologies are bringing curative living medicines to life to free patients from the siege of autoimmune disease.

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