Review and approve Master Production Records from Contract Manufacturing Organizations.
Ensure product is manufactured, tested, stored, and distributed according to cGMPs.
Provide Quality assessments and approvals for Change Controls impacting clinical or commercial products.
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). They are working to treat all forms of HI. More information can be found at rezolutebio.com
Monitor updates to EP, USP, Mexico Ph, ChP, and JP.
Analyze changes in compendial requirements.
Ensure timely implementation of compendial changes.
Vertex Pharmaceuticals is focused on the discovery, development and commercialization of medicines. They strive to transform the lives of people with serious diseases.
Manages curricula and learner roles, including periodic review of curricula, learner roles, and training requirements with department heads and QMS Admin.
Coordinates with study team leads to update study-specific training documents, routes for approvals, and manages study team learner role membership in the LMS.
Coordinates with document owners and Doc Control to create or revise Training Requirements with new or revised controlled documents and training materials.
Celcuity is a clinical-stage, publicly traded biotechnology company focused on extending the lives of cancer patients through targeted therapies for solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.
Lead development of phase-appropriate formulations and manufacturing processes for solid oral dosage forms.
Oversee technology transfer from development to clinical and commercial manufacturing.
Manage CDMOs, including selection, oversight, and performance management.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania.
Support site initiation, management, and close-out activities.
Ensure trial conduct complies with protocol and regulatory requirements.
Participate in data review and support site readiness.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease by staying true to their values and innovating boldly.
Ensure the development and implementation of action plans.
Lead regional/therapeutic area project resourcing.
Develop, mentor, manage and coach GCM Managers.
Precision for Medicine is a global precision medicine clinical research services organization. They improve the clinical research and development process for new therapeutics by integrating clinical operations excellence, laboratory expertise, and advanced data sciences.
Support regulatory strategy and submission timelines for US market
Own quality oversight of supplier relationships for US market
Lead CAPA investigations and effectiveness verification
Optain is a healthcare company using software and hardware to rethink care. They aim to improve the way we detect and manage eye and systemic conditions and have a close-knit and highly talented team.
Responsible for auditing Special Processes at manufacturing sites and suppliers.
Perform audits per NADCAP / customer requirements using checklists.
Document findings, work with sites on corrective actions.
KBR delivers science, technology, and engineering solutions to governments and companies worldwide, helping them accomplish critical missions. It employs approximately 29,000 people and has customers in over 80 countries with operations in 40 countries, focusing on innovation and sustainability.
Independently oversees all aspects of study site management to ensure patient safety is protected.
Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image.
Precision Medicine Group is expanding its capabilities across Latin America. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Develop and maintain a quality audit program for the Clinical Review Team.
Ensure high-quality reviews and adherence to regulatory requirements.
Deliver exceptional member, provider, and employee experiences.
SmithRx is a rapidly growing Health-Tech company that aims to disrupt the Pharmacy Benefit Management (PBM) sector using technology and customer service. The company has a mission-driven and collaborative culture, with hundreds of thousands of members onboarded since 2016.
Assume leadership and functional representation for projects ensuring effective coordination and management of regulatory deliverables.
Perform quality control of regulatory intelligence screening and ensure maintenance of the regulatory intelligence database.
Provide regulatory strategic input to internal and external customers and promptly identify and address any risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.