- 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
- Merck & Co. (Durham, NC)
- …collaboration with Technical Operations.Primary Activities Could Include:Executes critical site review and review of environmental monitoring data.Perform ... review of batch records and documentation.Perform review of process simulation batch records.Perform data ... review of process simulation batch records.Perform data review and run reconciliation activities as required (ie, UV… 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
- CoxHealth (Lake Spring, MO)
- …organize instrument sets * Able to pass a written proficiency review . * Organized and self-motivated with an attention to detail. ... organize instrument sets ▪ Able to pass a written proficiency review . ▪ Organized and self-motivated with an attention to detail.… more
- Skaggs Community Hospital Association (Branson, MO)
- …meeting numerous requests and deadlines. ▪ Continues education through current review of anesthesia practice (as defined by recertification requirements) and ... meeting numerous requests and deadlines. ▪ Continues education through current review of anesthesia practice (as defined by recertification requirements) and… 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
- Merck & Co. (Rahway, NJ)
- …main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business ... on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content management,… more
- CoxHealth (Lake Spring, MO)
- …organize instrument sets ▪ Able to pass a written proficiency review . ▪ Organized and self-motivated with an attention to detail. ... Description :Has a detailed working knowledge of department functions and is responsible for completing work assignments in the sterile process department.Education: ▪ Required: High School diploma or equivalent Experience: ▪ No prior experience required… 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
- CoxHealth (Lake Spring, MO)
- …physician documentation in the medical record through concurrent chart review . Interdisciplinary communication and collaboration with physicians, nursing, and ... ancillary staff including Health Information Management coders is key to the success of this position. This position is also responsible for ongoing education of the patient care team regarding proper clinical documentation utilizing approved guidelines.… 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
- LE Cox Medical Centers (Lake Spring, MO)
- …Laboratory Technicians). Responsible to perform testing which may require review by MT/MLS/MLT before verification. Processing and accessioning of specimens ... as assigned.Education: ▪ Required: Bachelor's degree ▪ Preferred: Bachelor's degree in an applied sciences related field Experience: ▪ Preferred: 1 Year experience in a laboratory or in medical training Skills: ▪ Strong analytical/problem solving skills. ▪… 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
- 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
