Manage third-party and FDR oversight, including due diligence, risk tiering, and ongoing monitoring.
Lead privacy and security incident response, including breach risk assessment and reporting.
Administer compliance program, including drafting policies, presenting training, and conducting internal audits.
Evermore is a technology company that administers Smart Benefits to connect people to products and services they need. It is a Series B stage company backed by leading investors, fostering a culture of innovation and health equity.
Manage site activation and regulatory submissions for clinical trials in Spain.
Oversee contract and budget negotiations with sites to ensure timely approvals.
Collaborate with cross-functional teams to maintain project documentation and timelines.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine for rare diseases and oncology. The company is experiencing continued growth and values operational excellence and regulatory expertise.
Lead analytical strategies for commercial products, ensuring compliant and robust methods and specifications.
Manage method transfers, validations, and lifecycle activities while collaborating with CDMOs and cross-functional teams.
Contribute analytical expertise to regulatory submissions and support health authority inspections.
The company is a science-driven biopharmaceutical organization focused on developing and commercializing small-molecule drugs. They foster a collaborative culture with engaged colleagues and emphasize scientific excellence.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Monitor operational activities for compliance with healthcare policies and established procedures
Support compliance reviews of billing, coding, claims, and documentation processes
Assist with internal audits, compliance assessments, and corrective action plans
Raventra Health is a medical services company providing outsourced billing, coding, and claims processing solutions for provider groups and hospitals. The company's size and culture are not specified in the posting.
Lead research governance and compliance processes for biomedical research programs, ensuring ethical and regulatory adherence.
Design data governance frameworks for sharing sensitive human data, balancing access with responsible stewardship.
Collaborate with scientific communities and institutional partners to implement governance systems that protect participant rights and research integrity.
Sage Bionetworks architects a more open, equitable, and data-driven scientific ecosystem by democratizing information and breaking down disciplinary barriers to accelerate research. Founded in 2009, this high-agility nonprofit fosters a culture of curiosity, innovation, and diverse perspectives, operating at the intersection of science, technology, and ethical data sharing.
Provides regulatory CMC support for drug-device combination products.
Reviews submission documentation and contributes to global regulatory strategies.
Collaborates with cross-functional teams including device development, quality, and clinical.
Vertex Pharmaceuticals is a global biotechnology company dedicated to developing transformative medicines for serious diseases. With thousands of employees, it fosters a collaborative and innovative culture focused on patient impact.
Lead pharmacovigilance strategy and operations across the portfolio, ensuring regulatory compliance and safety oversight.
Oversee outsourced PV vendors, build quality systems, and manage safety data exchange agreements.
Partner cross-functionally with Clinical Development, Regulatory, and Quality to advance pipeline from early to late-stage development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a lean organization with a build-oriented culture, advancing a pipeline from Phase 1 to Phase 3.
Lead and execute risk-based internal audits across pharmaceutical and medical device operations.
Serve as Lead Auditor for complex, multi-site audits, driving continuous improvement of the QMS.
Support inspection readiness and regulatory authority/notified body audits.
Agilent Technologies is a global leader in laboratory and clinical technologies, providing instruments, software, and consumables for life science research and diagnostics. With 18,000 employees, we foster an inclusive, dynamic culture built on trust and integrity.