- Johns Hopkins University (Baltimore, MD)
- …Research Nurse that will report to the Principal Investigator(s), Research Nurse Manager , and Lead Research Nurse. This position is responsible for the coordination ... Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc. _Communication_ + Independently/collaboratively performs responsibilities of… more
- Endo International (St. Louis, MO)
- …of validation documents + Familiar with data integrity guidance from MHRA and FDA + Management of data integrity gap assessments and remediation + Performs ... validation in a pharmaceutical manufacturing environment. Proven personnel and project management history. Complete knowledge of pharmaceutical regulations including… more
- Morehouse School Of Medicine (Atlanta, GA)
- …Practitioner Preceptor Position Title Agile Clinical Trial (ACT) Training Program Manager Position Type Non-Faculty Number of vacancies 1 Salary Commensurate with ... : This position may be responsible for supervising trainees and interns within a project . Minimum Qualifications + Bachelor of Science in Nursing ( BSN ) from a… more
- TestPros (MD)
- …ensure 508 compliance. Remediate documents with the time specified by the OD and OSC Project Manager (PM). Document that the documents fully passes the HHS and ... FDA checklists. Notify the PM when a document requires the insertion of Alt text. Perform final document remediation within ten (10) business days after the PM has… more
- North Coast Seafoods (Boston, MA)
- …usability of products. This position reports to the Quality Control Supervisor or Manager . DUTIES AND RESPONSIBILITES + Serve as the primary contact between the ... mathematical concepts + Strong analytical and problem-solving skills + Strong project management and organizational skills; able to prioritize and manage multiple… more
- University of Pennsylvania (Philadelphia, PA)
- …is expected to perform the duties above with more limited supervision from the project manager . In addition, will develop complex documents such as protocols and ... safety, protocol compliance, and data qualify. Adhere to all University of Pennsylvania, FDA , and GCP guidelines. Clinical Coordinator B, in addition to the above,… more
- Epredia (Portsmouth, NH)
- …ensure Epredia delivers excellent results. Reporting to the Sr. Manufacturing Engineering Manager , you'll work alongside a dynamic team of engineers while gaining ... + Design and execute Validation and/or Qualification exercises in accordance with FDA General principles of Software Validation. + Ensure processes and equipment… more
- Ascensia Diabetes Care (Portsmouth, NH)
- …ensure Epredia delivers excellent results. Reporting to the Sr. Manufacturing Engineering Manager , you'll work alongside a dynamic team of engineers while gaining ... + Design and execute Validation and/or Qualification exercises in accordance with FDA General principles of Software Validation. + Ensure processes and equipment… more
- PCI Pharma Services (Madison, WI)
- …activities by monitoring the production, and visual inspection schedules and project management deliverables, and reviewing factors that may impact schedules. + ... function of this position + Performs other duties as assigned by Manager /Supervisor. **Qualifications:** **Required:** + BS degree in a scientific discipline +… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... abstracts, posters and manuscripts. + Act as the lead project statistician for assigned phase 3b/4 clinical trials, leading...capture or external vendor data working with the data manager to identify and resolve issues as identified +… more