- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... input on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audits CAPA… more
- BioSpace (New York, NY)
- …enteral routes. Job Overview: The Clinical Trial Manager (CTM)/Clinical Research Associate is responsible for providing oversight of the Sponsor's outsourced ... trial services, with a primary focus on ensuring quality Clinical Research Associate (CRA) monitoring and data integrity across all programs. This individual will… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Associate Director , Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is ... responsible for the effective management of GCP , GVP and GLP inspections. The GDQIM IML will...functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials. **In… more
- System One (Tarrytown, NY)
- Job Title : Temp - Associate Director , Aggregate Reporting, GPS Type: Contract Compensation: $85 - $100 hourly (dependent on experience) Contractor Work Model: ... + Ability to interpret clinical data to support benefit-risk assessments. Temp - Associate Director , Aggregate Reporting, GPS + Submit Candidate + This position… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Associate Director (AD), GCOE Learning and Development responsible for managing the governance, configuration, and optimization of ... ensuring that curricula align with role requirements, training records meet inspection readiness standards, and study-specific training is executed consistently and… more
- Takeda Pharmaceuticals (Boston, MA)
- …share across CPMQ the compliance metrics for CPMQ activities eg audit, inspection , QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and ... CPMQ team on quality compliance activities. + Provide guidance and support to GCP , PV Health Authority inspections including logistics. + Present insights to the… more
- Lilly (Indianapolis, IN)
- …Help Desk personnel for study set-up and support questions. + Maintain GMP/ GCP compliance by following procedures applicable to clinical trial execution. + Actively ... with Quality to ensure all preparation is complete and reviewed prior to inspection /audit start. + Successfully operate in, and provide solutions to, complex working… more
- J&J Family of Companies (Spring House, PA)
- …The **Specialist, Early Development Risk Management,** reports to the Director , Early Development Clinical Risk Management. The Specialist Early Development ... requirements and internal procedures, and to maintain a continued state of inspection readiness. **Key Responsibilities** : With supervision from the Director ,… more
- PCI Pharma Services (Rockford, IL)
- …of security-related policies and standard operating procedures. + Maintain accurate inspection logs and incident records, advising management on deficiencies and ... and vendors while upholding departmental protocols. + Under the direction of the Director of Security or Security Manager, mentor, train, and supervise a team of… more
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