- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance ... exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control laboratories in support of both… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …affairs team as necessary. Implement and maintain processes to ensure compliance with electronic submission formats and global regulatory standards, and identifies ... management certifications (eg, PMP, PRINCE2) preferred.Experience as a project manager preferred.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...submission-relevant activities are performed.Liaise with the Global Audits and Compliance function to ensure compliance with programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SAP).Study Execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical ... data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with ... Activities: Responsible for development and review of procedural documents that set compliance in QA GMP commercial and IMP processes and systems. Responsible to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... documentation of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position will establish… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and ... experience including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit.Demonstrated experience dealing with contract manufacturing organizationsMust… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring ... compliance with technical and regulatory standards. This role involves...communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high-quality deliverables, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to...(minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , ... assessment and cleaning efficacy studiesStrong understanding of regulatory and compliance requirementsExcellent oral and written communication skills Highly collaborative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... media relations, internal communications, public disclosures, social media policies, compliance , crisis communications, and diversity initiatives. Develops contract templates,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities Prior TMF… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sample materials.Perform spot-checks in the QC Laboratories to ensure compliance with written regulations, policies, procedures, and global procedures.Strive to ... reduce non-conformances in supported areas by proactively driving compliance .Perform tasks in a manner consistent with the safety policies, quality systems and cGMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.Creates, implements, and presents training programs and materials on ... post-law school experience required4 or More Years experience in regulatory, compliance , and legal matters relating to investigational products, product promotion,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regarding actions to be taken on each request, communicate with counsel and compliance on a regular basis. Communicate daily with colleagues of PGC to assist ... company agreements. As necessary, negotiate with opposing party with support from manager or attorneys to resolve contract language disputes. Communicate daily with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.Work closely with operations ... records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees ... or biotechnology industry (including minimum 2 years as a Senior Product Manager or equivalent) in positions of increasing strategic and technical responsibility.… more
