- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Regional Quality Leads, External Partner Quality Leads, and Business Partner Quality Leads based on assigned programs and in close ... to the external partner (CRO, co-sponsor, specialty vendor).Support the Business Partner Quality Lead(s) (BPQLs), who are responsible for delivering and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance ... Chain, Medical Information Social Media and other suppliers. Develop governance, business continuity, quality , and vendor monitoring plans. Maintain oversight… more
- Merck & Co. (Rahway, NJ)
- …The position will be heavily involved in close collaboration with the contractor quality and technical personnel and will partner with internal development teams ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality and accurate labeling in support of ... Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages new projects and projects of increased… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality and accurate labeling in support of ... Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages new projects and projects of increased… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drive process and policy adaptation within the support teams and across business units. The GSM is responsible for the training, performance tracking, and ... ensure processes are implemented, followed, and aligned with the business and Global IT strategy. The GSM is responsible...The GSM works closely with QA during regulatory agency, partner , and internal audits and Inspections, and is the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … partnership with various business functions of Daiichi Sankyo. As a trusted partner , provide oversight of business demand to balance IT portfolio and to ... and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS) in the US,...in the areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tech Lead must develop and implement informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global ... sites. These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs,… more
- Merck & Co. (Rahway, NJ)
- …achieved business results. This focus allows the team to be a crucial supporting partner with the business to help them gain concrete business value ... leaders across all divisions to support the CIO's vision of an agile, business outcomes-focused IT organization, and will partner with other Technical, Systems,… more
- Merck & Co. (Rahway, NJ)
- …and/or investigations, as needed.Maintain training and compliance with site safety and quality requirements. Partner with outside groups, including Quality , ... to the team of Clinical Packaging Technicians, ensuring that business objectives are met and that a high standard...objectives are met and that a high standard for Quality and Safety compliance is maintained.- The position will… more
- Merck & Co. (Rahway, NJ)
- …achieved business results. This focus allows the team to be a crucial supporting partner with the business to help them gain concrete business value ... is to provide strategic technology decisions that link investments and achieved business outcomes. Our goal is to offer strategic technology decision-making that… more
- Merck & Co. (Rahway, NJ)
- …Discovery Process Chemistry, Enabling Technologies, Chemical Engineering R&D, Analytical R&D, Quality , and other our Company's partner groups to provide ... external partners.- Promotes a culture of scientific excellence, trust, collaboration, quality , safety and compliance that extends beyond our Company's team and… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... to build an integrated culture of innovation across modalities and will partner with cross-functional development teams to enable pipeline decisions. -The Executive… more
- Merck & Co. (Rahway, NJ)
- …innovative thinking, state-of-the-art facilities, and robust scientific methodology, we partner to deliver the next medical breakthrough.Biologics Process Research & ... engineers to advance the biologics pipeline from early- to late-stage development. Partner with groups in both research and manufacturing divisionsRepresent your… more
- Merck & Co. (Rahway, NJ)
- … processes, roles and responsibilities, and role-based training associated with core business processes. Partner with Business System Owners on Alignment ... overseeing and managing Global Regulatory Affairs & Clinical Safety global business processes. This includes defining and optimizing end-to-end processes and… more
- Merck & Co. (Rahway, NJ)
- …between clinical development teams and the operational/executional arms within the business . The Program Clinical Supplies Project Manager serves as the primary ... activities include, but are not limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative)… more
- Merck & Co. (Rahway, NJ)
- …eliminates obstacles / barriers to implement changeAbility to present clear and compelling quality and business cases.- Ability to engage and align other ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …to gain insights into the company's performance, thereby enhancing their business acumen for future opportunities.Reporting directly to the Director of Consolidation ... reviewing consolidation journal entries, including post-closing adjustments for various business divisions and legal entities.Conduct comprehensive analyses of financial… more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. ... tables and figures according to statistical/modeling analysis plan.This position will partner with stakeholders to solve problems; reduce the amount of programming… more
- Merck & Co. (Rahway, NJ)
- …key interface between clinical development teams and the operational/executional arms within the business . - - This role works with in the Planning Execution and ... strategy for clinical supplies . - Interacts with key partner s in both GCS (Logistics and Trade, Distribution,...rial O perations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics .… more
