Kyverna Therapeutics
Medical Writing Operations Manager (Contract)
Kyverna Therapeutics, Myrtle Point, Oregon, United States, 97458
Overview
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
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
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
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.
#J-18808-Ljbffr
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
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
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
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.
#J-18808-Ljbffr