- 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 ... Reports and other safety reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor on Patient Safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety, with cross-functional working relationships within Intake and Triage, Medical Review , Submissions and Compliance, Global Safety, and centralized teams (eg, ... Training and Documentation , Quality, Supplier and Contract Management and Digital Enablement)....patient safety leadership team members in Data Acquisition, Medical Review , and other case management leadership team members. External… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …PS Case Management is responsible for the management of receipt, documentation , triage and case processing safety information and associated quality complaints ... Patient Safety and Safety Surveillance teams. Works closely with Promotional Review Board as required. Essential Functions Perform initial evaluation of reported… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendor call scripts, including stewarding material through the Promotional Review Board process (if applicable) Optimizes multi-media communication (letters, emails, ... KTA teams. Manages all aspects of training materials creation and documentation to ensure vendor compliance Program Compliance: Implements recommendations and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …smooth operational alignment and compliance with GxP requirements Key Area #3 Review and approve vendor-related Standard Operating Procedures (SOPs) and ensure ... documentation meets regulatory and internal standards Maintain up-to-date knowledge of industry regulations and guidelines to ensure compliance with adverse event… more
- Tris Pharma (Monmouth Junction, NJ)
- …rules and regulations Adheres to cGMPs and current Good Documentation Practices (cGDPs)RequirementsRequirementsMinimum education and years of relevant work ... related to sampling methods, quality control systems, analysis and documentation practices and proceduresTravel requirements:0%Physical requirements:Laboratory based position Ability… more
- Genscript USA Inc. (Piscataway, NJ)
- …lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor submittals ... commissioning of MEP systems, ensuring performance verification and turnover documentation are complete. Support construction scheduling, cost control, and quality… more
- Tris Pharma (Monmouth Junction, NJ)
- …transactions and promptly resolves discrepancies Owns technical accounting research and documentation ; Drafts white papers and accounting memos to support audit and ... and experience level relative to requirements of the position and a review of related industry standards and internal equity.Additional benefits: In addition to… more
- Sampled (Piscataway, NJ)
- …Own and execute the monthly close process, including preparation and review of journal entries, accruals, and reconciliations. Perform and oversee bank ... the annual financial audits, including preparation of audit schedules and documentation Drive continuous improvement in accounting processes, leveraging systems such… more
- Everon (Edison, NJ)
- …tasks. + Ensures the progress and completion of assigned tasks. + Provides documentation of service and hours worked. + Completes and submits all required ... task-related activities, productivity, and other documentation in a timely manner. + Must have a...pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the… more
- Hovione (Cranbury, NJ)
- …- To execute, with supervision, the production/HSE processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an ... transferred Operators from other areas. - Follow all annual performance review requirements, including completion of the self-assessment. - Ensure facility… more
- Integra LifeSciences (Plainsboro, NJ)
- …+ Perform daily, in-process reviews of batch records to support good documentation practices + Develop, redline, and/or review associated manufacturing ... documentation To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. **DESIRED MINIMUM QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability desired for… more
- Merck & Co. (Rahway, NJ)
- …supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. Works directly in the ... Drug Product and Clinical Finished Goods). Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… more
- Formation Bio (New York, NY)
- …and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review and approval of batch records, ... release testing, and other quality-related documentation . Foster a culture of continuous improvement and development within the quality assurance team, ensuring that… more
- Merck & Co. (Rahway, NJ)
- …the team accountable to deliver on priorities.Document preparation, maintenance, and review of documentation including specifications, testing protocols, testing ... reports, technical memos and supplier assessmentsRemain informed of current Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry standardsMinimum… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …system users with workflow handling and electronic system usageManage the periodic review process for proceduresIssuance of batch related documentation in ... and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance… more
- SMBC (New York, NY)
- …and experienced program manager to join our team. The Program Management and Documentation VP will be responsible for overseeing and managing various programs and ... requirements, internal policy, and industry standards. Develop clear and concise documentation , including user manuals, process guides, and training materials, 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 … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …labels, forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ensuring compliance ... Operations team based in Raritan, NJ. Role OverviewThe Batch Record and Documentation Coordinator will work in a detail-oriented compliant manner coordinating the… more
