- Legend Biotech USA, Inc. (Raritan, NJ)
- …periodic review process for procedures, as needed.Issue batch related documentation and labels in support of GMP manufacturing.Reconcile GMP documentation ... Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with… more
- Tris Pharma (Monmouth Junction, NJ)
- …Legal team.The Contracts Manager/Paralegal supports the Legal department in the review , drafting and compilation of varied and complex business contracts across ... licensing and compliance requirements, including preparing and filing necessary documentation Manages company's IP portfolio, including trademark and copyright… more
- Genmab (Plainsboro, NJ)
- …learningsRepresents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results ... adequate methods for which a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by… more
- Merck & Co. (Rahway, NJ)
- …for and support batch processing readiness and execution activities.Prepare, review , and/or approve GMP Documentation as appropriate.Author/Approve Standard ... through participation in equipment design and testing as well as preparation, review , and completion of GMP documentation .Support compliance with Industrial… more
- Merck & Co. (Rahway, NJ)
- …for and support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... in equipment design and testing as well as preparation, review , and completion of GMP documentation . Support...as preparation, review , and completion of GMP documentation . Support compliance with Industrial Hygiene (IH) program by… more
- Merck & Co. (Rahway, NJ)
- …and standards.-MAJOR ACTIVITIES AND RESPONSIBILITIES: Major activities and responsibilities include: Review animal health pre-clinical and clinical study reports and ... audit reports.- Reviews audit responses to ensure appropriate actions and documentation has occurred.- Distributes audits to management.Assist in performing facility… more
- Merck & Co. (New York, NY)
- …product workshops and conferences, as well as consistent and ongoing review of our Company promotional materials.Regularly monitoring their business performance ... and comply with legal and ethical standards.Maintain accurate and timely documentation of customer interactions and adhere to reporting requirements.Stay informed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leadership.Collaborate on the development of monitoring plan templates including review and annotation of monitoring-related documentation .Contribute to and ... study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies to identify, track, store, and disseminate critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and ... Accountable for budget records and prepares documents required for the budget review processes Develops requests for proposals; evaluates and provides input into… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated ... CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and WHO Drug Coding dictionaries) including dictionary support documentation . Collaborates cross-functionally with the Medical, Clinical Development, Clinical ... of the coded data and adherence to regulatory requirements. Develops and maintains documentation of items on medical coding, including but not limited to Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.Provide operational ... input into study protocol profiles, final protocols and amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …promptly in the MKC Support both clients and the management team with documentation and any additional requests to ensure seamless event execution. Relationship This ... outcomes Ensures consistency in support provided by the team through continuous review and improvement of existing processes Interprets and communicates goals and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP decisions.Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, ... Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop positive relationships with the QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position oversees the creation of SAE Flow Plans and may perform final review . This position provides input on electronic data capture (EDC) Safety report outputs, ... and provides input to SOPs, SOIs, and process guides.Clinical Study Start-Up Documentation : Reviews all clinical study protocols to ensure consistency in safety… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Monitor test execution, adjust schedule as needed to address tests failures. Documentation : Maintain detailed documentation of tests schedules, procedures, and ... workload to be evenly distributed amongst all analysts.Audit support: Ensure Good Documentation Practices and lab readiness are upheld for potential support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents.Manage external vendors and ensure accurate and high-quality deliverables. Ensure documentation and consistent maintenance of code, logs and output within ... as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams. Develop,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports ... PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts (eg development, license, distribution… more
