- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of Individual ... safety reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and...coaching and meeting the compliance requirements for the Medical Review Team. Relationship Reports directly to Head of PV… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendor related activities in Patient Safety including, but not limited to contract review and vendor management support in regard to safety reporting. To serves as ... initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, management of SDEA requirements, and supplier… more
- Merck & Co. (Millsboro, DE)
- …Quality Specialist ensures product/process quality system adherence and batch record review , completes quality checks and SAP transactions required to release ... and works in a team environment to ensure timely review and documentation is Right First Time. The successful...which they are assigned to support. - Performs Quality review , approval, and submission of finished product serials. -… more
- Cipla (Hauppauge, NY)
- …3:00pm - 11:30pm Job Overview: The QA Associate (Reviewer) is responsible for review of batch production records, ensuring that all documentation complies with Good ... produced according to the approved methods and specifications. Responsibilities: Review batch production records (BPRs), including associated documents (eg,… more
- Cipla (Hauppauge, NY)
- …supporting manufacturing processes, with a particular focus on audit trail review , data integrity, and overall GxP compliance. Responsibilities: Perform detailed ... actions in the audit trails and escalate as needed. Review user activity logs within the batch record systems...actions are secure, traceable, and compliant with regulatory standard. Review of the batch records (manufacturing and packaging) to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within company policies, procedures, and all applicable regulations.Key Responsibilities Review documentation for all manufacturing activities executed in accordance ... with Good Documentation Practices (GDP). Review documentation for miscellaneous activities executed in accordance with Good Documentation Practices (GDP).Work in a… more
- Insmed Incorporated (NJ)
- …Collaborate with internal teams, CROs, and external vendors to prepare, review , and finalize clinical protocol documents.Contribute to scientific and operational ... study design planning through final reporting of result.Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study… more
- Cipla (Fall River, MA)
- …duties for this position include but are not limited to the following : Review of batch manufacturing/packaging record. Review of engineering records such as ... and PM records, pest control records and contractor related functions. Review and approval of manufacturing/engineering non-conformances. Review and approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received ... PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts under negotiation (eg development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Quality Assurance for NN Deviation process within the PV domain, including review and disposition of submitted deviations in the Vault Quality system. Supports ... in the role of Quality Assurance for NN Change Control process, including review and disposition of submitted change requests in the Vault Quality system. Execute… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Compliance initiatives, such as inspection readiness, metrics implementation and review , overall regulatory compliance and implementation programs, and others as ... development and gathering of quality metrics for Legend's Quality Management Review (QMR).Support management of the Quality Management Review (QMR)… more
- Merck & Co. (Rahway, NJ)
- …and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... share and align on best practices. Author lessons learnt through after action review summaries or other reports to capture knowledge gained. Drive new technology… more
- Cipla (Central Islip, NY)
- …/ comparison reports and any other study reports. Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same. Verifying ... or other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review... Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... Operations and other cross-functional and regional stakeholders.- Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Daiichi Sankyo's mission by leading conversations across functional teams (ie Grant Review Committees) around the grant and/or project decisions that meet the ... Internal Strategy and Operations- In alignment with senior colleagues, collect, review , and make decisions in collaboration with relevant Medical Affairs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices ... (GDP). Review , revise, or draft Standard Operating Procedures (SOPs)Support processes...ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing attorney Provide Legal Support and Counseling in Contracting Process Review , draft, and negotiate a wide range of high-complexity, high-risk ... of legal and contracting matters Support and assist in contract review overflow, special projects, or contracting for other complex business transactions,… more
- ValSource, Inc. (Durham, NC)
- …conduct Risk Assessments and Impact assessments, and establish system boundaries Generation, Review , and editing of Standard Operating Procedures. Review and ... duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial… more
- HealthCare Support (Houston, TX)
- Utilization Review RN HealthCare Support is actively seeking a Utilization Review RN to fill an opening with a Prestigious HealthCare Company in Remote Houston ... TX . Daily Responsibilities for Utilization Review RN: WIll need to use their OWN EQUIPMENT:...MAC or any other seem to work fine) 1. Review telephonic and faxed clinical information to authorize medically… more
- AUROBINDO (Durham, NC)
- …(In-Process Quality Assurance) functions during IPQA absences.ResponsibilitiesCoordinate production priorities. Review IPQA entries in batch records on the ... floor.Assist in batch review .Coordinate printed packaging material release.Coordinate annual CV program.Assist in APR entry/ approval. Review and approve COA in… more
