Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Coordinate clinical trial site activities and support successful site start-up and activation.
Serve as a primary point of contact for investigative sites, facilitating communication among clinical teams, sponsors, CROs, and regulatory stakeholders.
Ensure compliance with ICH/GCP guidelines, manage essential documentation, regulatory submissions, and site activation milestones.
This role is listed on behalf of a partner company in the clinical research sector, focused on coordinating site start-up and activation for clinical trials. The culture emphasizes operational excellence, collaboration, and patient safety, with a remote working environment.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
Oversee collection, evaluation, and reporting of safety data from clinical trials, shaping the safety governance framework.
Manage PV vendor contracts, quality/compliance for ICSR case processing, and mentor PV operations associates.
MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.
Own CMC end-to-end for a trispecific TCE program from discovery handoff to IND, including timeline, budget, and quality.
Run competitive CDMO selection across US, European and Chinese vendors, then negotiate and manage the chosen partner.
Author Module 3, build the pre-IND briefing package, and represent CMC in agency meetings.
Shennon Biotechnologies is developing precision immunotherapies for solid tumors using an integrated platform that profiles millions of single-cell interactions in a single experiment. The company values collaboration, ownership and authenticity and is based in San Francisco.
Develop and operationalize QA frameworks for AI tools, including testing protocols, evaluation rubrics, and monitoring systems.
Conduct pre- and post-production evaluation of AI outputs for clinical safety, accuracy, bias, and regulatory alignment.
Analyze QA findings and trends to generate actionable Clinical AI QA reporting and drive improvements.
BetterHelp removes barriers to therapy, making mental health care accessible to everyone. As the world's largest online therapy service with over 30,000 licensed therapists, we deeply invest in our team's well-being and professional development.
Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.
The hiring company is a pharmaceutical organization focused on developing and maintaining labeling strategies for innovative treatments. It offers a globally connected remote work environment that values precision, collaboration, and continuous professional development.
Conduct detailed medical record audits to assess coding accuracy, documentation quality, and regulatory compliance.
Interpret CMS and payer guidance to identify compliance gaps and provide actionable recommendations.
Prepare audit reports and deliver provider education to improve billing accuracy and reduce risk.
This role is with a partner company specializing in healthcare compliance and coding audits for diverse healthcare settings. The collaborative, client-focused environment values analytical thinking, professional integrity, and continuous learning.
Oversee healthcare compliance programs covering Medicare billing, HIPAA, FDA regulations, and anti-kickback laws.
Conduct monthly billing audits, regulatory monitoring, and staff training to minimize risk.
Lead breach investigations, manage corrective actions, and collaborate with leadership and legal counsel.
They deliver innovative healthcare technology for remote patient monitoring, emphasizing patient safety and responsible AI use. The culture values compliance, accountability, and cross-functional collaboration among clinical, billing, and operational teams.
Drive global PV Operations strategy, including planning, implementation, and management, in alignment with the Head of DSPV.
Oversee vendor oversight, case management, compliance, inspection readiness, and budget/resourcing.
Represent DSPV Operations to senior leadership, manage talent, and ensure global regulatory compliance.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, we foster a culture of empathy, owner's mindset, and urgency because patients are counting on us.