- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and integrity of Study ... knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements Demonstrated experience… more
- Cipla (Hauppauge, NY)
- …and associated documentation meet regulatory requirements from agencies such as the FDA , EMA, and other relevant authorities. Review, creation and revision of BPRs, ... fully compliant for both internal and external audits (eg, FDA , GMP inspections). Assist audit teams by providing required...of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and… more
- Cipla (Hauppauge, NY)
- …Ensure that the artwork complies with all relevant regulatory guidelines (eg, FDA , EMA) and industry standards, including proper labeling, dosage information, and ... maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during… more
- Aptyx (Taunton, MA)
- …secondary operations on medical devices in compliance with ISO 13485, ISO 9001, FDA regulations, and Good Manufacturing Practices (GMP). This role is critical to ... packaging, and secondary manufacturing operations as assigned. Follow all GMP, FDA , ISO, environmental, and company quality system requirements. Adhere to… more
- Bayer (WA)
- …Medical Inquires in collaboration with Medical Communications;Adherence to SOP and FDA guidance for distribution of scientific information;Adherence to SOP and ... strategic partnership and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as part of… more
- Bayer (Nashville, TN)
- …Medical Inquires in collaboration with Medical Communications; Adherence to SOP and FDA guidance for distribution of scientific information; Adherence to SOP and ... strategic partnership and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as part of… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk ... clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and implement… more
- Cipla (Central Islip, NY)
- …5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical chemistry/lab background and ... other departmental and cross-functional projects and assignments given by the manager /supervisor. Education and Experience Possess a minimum bachelor's degree in… more
- Aequor (Tampa, FL)
- …Group, QA, Warehouse and Facility operations by complying with company and FDA cGMP requirements. Responsible for the performance of cleaning of Primary and ... observations to QA, Team Lead, Equipment Specialist CPS Project Coordinator or Manager of potential issues that could result in deviation or investigation. Perform… more
- Cipla (Fall River, MA)
- …- 5:00 PM (may vary based on business needs) Reports To : Packaging Manager Pay Range: $78,000 - $99,840 Purpose: InvaGen Pharmaceuticals, Inc. is searching for ... ensures compliance with cGMP's, InvaGen Pharmaceutical's policies,standard operating procedures, and FDA requirements. The incumbent will serve as a key resource… more
