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- West Los Angeles area, CA

Growing Oncology Clinical Trial site in the west side of Los Angeles has an opening for a Regulatory (IRB) Associate. This is a contract position while the incumbent is on maternity leave. Responsibilities:Will provide support for clinical research protocols, informed consents, etc.Will assist with all aspects of clinical research regulatory to ensure compliance to regulations and protection of human subjectsPrepare and submit documents to the IRBRequirements:Bachelor's degree required1+....


Sr. Clinical Trial Manager San Francisco Bay Area The Sr. Clinical Trial Manager (Full Time, Onsite OR Contractor - 12 months, Onsite) will oversee and manage all operational aspects of phase I – III clinical trials with minimal oversight from protocol to end.Responsible for leading a cross functional team (or participating as a lead) in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk.Responsible for project management....


Senior Clinical Data Manager, CDM - San Francisco Bay Area Our client, a progressive biopharmaceutical company with multiple trials in Phase I-III, has a new opportunity for a Senior Clinical Data Manager professional with oncology expertise in the San Francisco Bay. This person will drive and manage Clinical Study data. This is a full-time, onsite, senior role with a primary focus on the discovery and development of oncology drugs. The ideal candidate be an integral part of a team of....


SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout lifecycle. Senior....


ASSOCIATE DIRECTOR / DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a global pharma company, has a new opportunity for an Associate Director / Director level Regulatory Affairs professional with CMC expertise in Central NJ, to help drive US and Global Regulatory projects. This is a full-time Associate Director / Director level role with a primary focus in small molecule development. Independently manages all regulatory CMC business for drug candidates/products throughout lifecycle. Associate....


Job Description: Establishes and monitors Quality Assurance and Regulatory Affairs procedures and activities. Ensures the enrollment and participation of the Clinical Laboratory in an approved proficiency testing program for all tests performed. Design, implement and maintain Quality Metrics. Performs other duties as assigned. QUALIFICATIONS: Education/Skills: B.S. Degree in Medical Technology or educational equivalent. Licensure: MT or equivalent. Experience: A minimum of one year recent....


Directs the regulatory process for both US and Canada governmental approvals ensure necessary documentation is filed and all government interactions are handled appropriately. Develops processes and procedures to ensure regulatory compliance and provides sound risk assessments with regards to changes in animal health manufacturing processes.Completes submissions and internal assessments for regulatory reviewsParticipates in FDA audits and correspondences; for regulatory needs, acts as primary....

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