sciences, engineering or other technical/scientific area. Strong industry experience in Quality Assurance, Development...
Responsibilities and Requirements: Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project te...
Responsibilities and Requirements: Handling data management and retrieval of regulatory documents. Preparing and submitting US regulatory filings on time and in compliance. Staying current with regulations and providing expertise in reg...
Responsibilities: Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews, and approves engineering changes. Acts as cor...
Responsibilities: Leads all clinical data management activities for assigned clinical studies ensuring all timelines are met with best quality. Responsible for overseeing creation and approval of DM study documentation by vendors/CROs (i...
Responsibilities: Understanding of clinical trial objectives, design, endpoints and procedures defined in Protocol and Statistical Analysis. Develop programs that convert raw SAS datasets into standard format and improve existing program...
Responsibilities: Supports the plant Exception Report/CAPA System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for Client North Chicago product manufacturin...
Responsibilities: Manage Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies, delegating tasks as needed. Interact effectively with sponsors and oversee vendors. Ment...
Responsibilities: Maintaining the integrity of the client Quality System Act as a single point-of-contact to interface with Client division customers Develop and manage documentation for engineering studies ( "ES”). Execute ES activitie...