Lead global pharmacovigilance operations for clinical trials and post-marketing safety.
Ensure regulatory compliance with FDA, ICH, and GVP standards across international markets.
Build and mentor high-performing teams while driving business development and financial performance.
The company is a fast-growing clinical research organization specializing in pharmacovigilance and drug safety. It emphasizes operational excellence, regulatory compliance, and patient safety, with a global reach and a collaborative culture.
Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Conduct remote audits of medical device quality management systems against ISO 13485 and EU MDR.
Review objective evidence, identify findings, and deliver structured audit reports.
Apply sound regulatory judgement and support continuous improvement of audit processes.
The partner company specializes in assessing innovative health technologies and ensuring regulatory compliance for medical devices. It operates with a quality-focused culture, valuing autonomy and regulatory expertise.
Provide strategic leadership and oversight for all clinical data management activities across the development program.
Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
Oversee vendor management, data governance, and delivery of inspection-ready clinical data.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.
Provide expert knowledge on day-to-day clinical pharmacology workflows for regulatory submissions.
Identify common tasks and problems where AI can add value in pharmacology workflows.
Generate and review ground-truth artifacts to evaluate AI platform outputs for regulatory-grade quality.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a team of top researchers and engineers across AI and biology to build an AI scientist, fostering a fast-moving, mission-driven culture.
Manage provider and clinic compliance relationships, including onboarding and edge case resolution for approximately 3,500 clinics.
Lead investigations into prescribing pattern anomalies and credential lapses, producing written summaries and communicating outcomes.
Build and deliver compliance training for the sales team and develop provider-facing educational materials.
Strive Pharmacy is a personalized compounding pharmacy focused on individualized care and genuine partnership with patients and providers. The company is growing and seeks people who share their conviction for a more human approach to healthcare.
Conduct quality control reviews of participant visits and source documentation in the CRIO eSource system to ensure compliance with GCP, ALCOA principles, and client standards.
Identify missing documentation, inconsistencies, protocol deviations, and transcription errors, and document findings in tracking systems.
Collaborate with site personnel to communicate findings, support corrective actions, and contribute to continuous improvement initiatives.
UniTriTeam is a women-owned global workforce solutions organization specializing in clinical research operations, technology, and strategic staffing support. The team is collaborative, accountable, and committed to delivering excellence and integrity.
Provide strategic regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.
Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.
Develop global clinical strategies to support clinical evidence requirements for product submissions.
Ensure adequate monitoring is conducted on all clinical trials and work directly with regulatory bodies for approvals.
Select, interface with, and assure training of investigators, physicians, and clinical staff.
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance patients' lives, and supplies high-end niche batteries for specialized markets. We are guided by six Values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity, fostering a culture of passionate excellence within our team of over 10,000 employees.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.