Experience in healthcare/medical device sales a plus. STI) is a private, employee-owned company (ESOP) that provides engineering consulting and product development with a focus on safety. Performs work in a manner consistent with all company policies and safety.
Partners closely with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned and value-generating regulatory strategies. The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory stra
Under the general supervision of a licensed care provider and/or management, the Clinical Medical Assistant I (CMA I)/ Patient Access Representative II (PAR II) is responsible to function as both a CMA I and a PAR II. Per standardized clinical protocols, independently provides and documents clinical
Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus
Under the general supervision of a licensed care provider and/or management, the Clinical Medical Assistant I (CMA I)/ Patient Access Representative II (PAR II) is responsible to function as both a CMA I and a PAR II. Per standardized clinical protocols, independently provides and documents clinical
Working under general supervision the Safety QA Inspector conducts field inspections audits contractor safety programs documents safety observations and verifies compliance with applicable Occupational Safety and Health Administration (OSHA) California OSHA (Cal/OSHA) Airport Authority and project-s
The Medical Director will play a critical role in advancing clinical programs by partnering with Clinical Operations Regulatory Affairs Drug Safety Biometrics Translational Medicine Research and Medical Affairs colleagues. MD or DO degree with accredited residency training and board certification in
Under the general supervision of a licensed care provider and/or management, the Clinical Medical Assistant I (CMA I)/ Patient Access Representative II (PAR II) is responsible to function as both a CMA I and a PAR II. The staff member is responsible for securing and providing appropriate medical bus
Clinical/Medical Lab Scientists are highly skilled scientists who discover the presence or absence of disease and provide data that help physicians determine the best treatment for the patient. Clinical/Medical Lab Scientists. Clinical/Medical Lab Scientist generally work in a lab setting.
Under the general supervision of a licensed care provider and/or management, the Clinical Medical Assistant I (CMA I)/ Patient Access Representative II (PAR II) is responsible to function as both a CMA I and a PAR II. This position collaborates with interdisciplinary team to ensure optimal care is p
In close partnership with BMS's R&D Data organization and peer BI&T leaders, this role will help build an integrated, multi-year environment in which non-clinical evidence flows cleanly into translational, clinical pharmacology, regulatory, and Development decision-making. Improve how non-clinical e
The Director, Quality Assurance & Quality Systems will lead and support quality assurance and quality systems activities for Capricor's clinical and commercial-stage biotechnology operations. Quality Assurance and Quality Systems, with at least 5 years in a leadership role within a regulated industr
This leader will partner deeply with Clinical Pharmacology, Pharmacometrics, Quantitative Pharmacology, and Translational Medicine stakeholders to deliver the applications, modeling environments, workflow automation, and governed operational capabilities that support CPP work end to endfrom quantita
Serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development to ensure compliance with ICH-GCP, applicable regulations, and Artiva's procedures. As Senior Manager, Clinical QA, you'll lead risk-based GCP oversight across our cli
To qualify for the Regulatory Affairs Specialist III role, candidates must have a Bachelor's degree in life sciences, engineering, or a related field, along with at least 6 years of experience in a regulated environment, including 4 years of direct experience in Regulatory Affairs. The Regulatory Af
The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. Provide strategic and operational leadership in the planning and executing of
As a Senior Quality Analyst, you will monitor and support health plan quality improvement initiatives with particular emphasis on compliance with state and federal regulatory and accreditation requirements. Conduct quality of care reviews and investigations related to enrollee grievances, identified
The Senior Specialist works collaboratively with operational leaders, quality, patient safety, risk management, and system partners to support improved clinical outcomes, operational performance, regulatory compliance, and patient safety. Years experience in performance improvement, quality, patient
Artiva is seeking an Associate Director, Clinical Quality Assurance to serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development. Lead development and implementation of clinical quality procedures in collaboration with Clinic
Project Manager, Regulatory Affairs (Clinical and CMC). Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC. Proficiency in project management and regulatory systems is essential.