- System One (Andover, MA)
- Job Title: Quality Assurance Lead Investigator Location: Andover, MA Type: Contract Overview Leading pharmaceutical company looking for an experienced ... Quality Assurance Lead Investigator . Ideal candidates should have a High School Diploma with 10-15 years of relevant experience, or a Bachelors degree… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes. + **Team Leadership:** Lead , mentor, and develop a team ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities,… more
- Merck (Boston, MA)
- …objectives. + Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality ... **Job Description** The Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope… more
- Bausch + Lomb (Boston, MA)
- …(eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device Safety, and ... and changes in scope, schedule, and resources. + Organize investigator and expert meetings relevant to the indication and...ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… more
- Astellas Pharma (Boston, MA)
- …closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified ... and support. The CSM will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist...investigator meetings as needed. + May serve as Lead CSM for specific study providing study level oversight… more
- Takeda Pharmaceuticals (Boston, MA)
- …with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance , Medical Affairs, Marketing, Manufacturing, and Legal; ensure ... PDT with the following duties: Serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for...Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents. Up… more
- Takeda Pharmaceuticals (Boston, MA)
- …issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance , Medical Affairs, Marketing, Manufacturing, and Legal. + ... Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned… more