- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author ... and biostatistics to ensure availability of necessary dataCoordinate author review /approval internal review approvalSubmit abstract/manuscripts with vendor… more
- Merck & Co. (Rahway, NJ)
- …biophysics with a strong interest in high-throughput experimentation to join our Data Rich Experimentation (DRE) team within the Process Research & Development ... - Our DRE organization is responsible for the invention and application of new data -rich and digital tools to support the scientists across the Process Research &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working ... functional partners.Key Responsibilities Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control… more
- Commonwealth Care Alliance (Boston, MA)
- …to the Manager Utilization Management, the Nurse Utilization Management (UM) Reviewer is responsible for day-to-day timely clinical and service authorization ... review for medical necessity and decision-making. The Nurse Utilization Management Reviewer has a key role in ensuring CCA meets CMS compliance standards in the… more
- The Joint Commission (Oakbrook Terrace, IL)
- …including without limitation inspections, required conferences, tours and interviews with staff. + Review and interpret all data submitted by the organization. + ... Field Representatives, with minimal direction or supervision, survey and/or review health care organizations throughout the United States. Field Representatives… more
- Insmed Incorporated (San Diego, CA)
- …checks, report development, and database lock processesParticipate in activities related to data review , database lock, medical monitoring, and query resolution ... through final reporting of results Provide scientific input and review of clinical study data , support in...scientific input and review of clinical study data , support in assessing medical monitoring reports, study integrity/conduct,… more
- Insmed Incorporated (NJ)
- …checks, report development, and database lock processes.Participate in activities related to data review , database lock, and query resolution for the ... development experience.Strong medical writing and presentation skills.Understanding of biostatistics and data management.Strong data review and analytical… more
- Cipla (Hauppauge, NY)
- …systems supporting manufacturing processes, with a particular focus on audit trail review , data integrity, and overall GxP compliance. Responsibilities: Perform ... each modification or action taken within the system (eg, data entry, process changes, approvals) is appropriately logged, timestamped,...actions in the audit trails and escalate as needed. Review user activity logs within the batch record systems… more
- Aequor (South San Francisco, CA)
- …makes modifications as necessary Develops and implements new protocols with moderate review Engages coworkers in scientific discussions Communicates data and ... degree & 2 YOE OR Masters' degree To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts… more
- Repligen (Rancho Dominguez, CA)
- …/ raw materials specifications.Performing testing, validation, equipment qualifications, and data analysis. Make recommendations for changes in equipment, products, ... criteria and provisions for effective inspection and testing.Compiling and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will ... utilities, and facility qualification, process validation, shipping validation, and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer… more
- Merck & Co. (Rahway, NJ)
- …Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review , Employee Training Programs, FDA ... main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business… more
- Merck & Co. (TX)
- …DescriptionAs a Senior Platform Engineer you will design, deploy, and maintain data platforms, predominantly concentrating on Databricks. - This role involves both ... for the enterprise-wide implementation of Databricks platform . Author, review , and maintain Terraform modules and state management for… more
- Cipla (Central Islip, NY)
- …Pharmacopoeia are in effect. Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the ... the supervisor of necessary improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and… more
- Aequor (Walkersville, MD)
- …teams to prevent production delays. Planning Oversight: Maintains accurate material master data and planning parameters in SAP ECC to balance service levels, ... between Planning, Purchasing, and Quality, and reduce waste through data -driven analysis and system optimization. Problem Resolution: Investigates and resolves… more
- Eisai, Inc (NJ)
- …lead high-impact imaging strategies-from trial design and execution to data interpretation-while driving scientific innovation and operational excellence. The ... translational and clinical goals. At the same time, they will ensure data quality, harmonization across teams, and continuous process improvement, making a… more
- Insmed Incorporated (NJ)
- …opportunity to support Insmed's Procure-to-Pay (P2P) transformation by assisting with data integrity, process analysis, and system readiness efforts as we prepare ... implementation of our new financial system. You'll also: Assist with supplier data clean-up, validation, and maintenance to ensure accuracy across procurement and… more
- Aequor (Fort Worth, TX)
- …Receive and inspect biological raw materials (eg, cell lines, reagents, growth media). Review data from contract microbiology labs to ensure accuracy and ... regulatory compliance. Prepare or review method transfer documentation for biological assays, including technical transfer protocols or reports. Perform validations… more
- Cipla (Hauppauge, NY)
- …operating procedures (SOPs). Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the ... the supervisor of necessary improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional ... protocol profiles, final protocols and amendments-Participate in protocol and amendment review .Contribute to the development of and oversee delivery timelines of… more
