- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... Americas business. You oversee business continuity, disaster recovery, and crisis management , while also educating end-users on compliance requirements.… more
- Eisai, Inc (Nutley, NJ)
- …in implementing and maintaining robust cybersecurity practices, including risk management , access controls, network security, and compliance , is ... we want to hear from you. Job Summary: As the Americas Infrastructure Director , your role involves collaborating with other Eisai regions and global Enterprise… more
- Eisai, Inc (Nutley, NJ)
- …incumbent is expected to be a team player, and an advocate for quality , compliance , professionalism, and core corporate values at Eisai. Essential Functions ... assessment of Eisai Neurology products, and will be responsible to deliver high quality and impactful models to ensure optimal patient access. In addition, the… more
- Eisai, Inc (Nutley, NJ)
- …incumbent is expected to be a team player, and an advocate for quality , compliance , professionalism, and core corporate values at Eisai. Responsibilities ... as needed.Overall, the incumbent is entrusted with the leadership and effective management of statistical activities, contributing significantly to the success of a… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... with CMC and Regulatory in aspects of control strategy and filings, Quality , and our partners in the commercialization and manufacturing division.This challenging… more
- Merck & Co. (Rahway, NJ)
- …support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance :-Develop and implement protocols and ... Job DescriptionAssociate Director - Digital Forensics Position Summary:-We are seeking a highly skilled and experienced professional to join our team as an Associate… more
- Merck & Co. (Rahway, NJ)
- … quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position ... management and follow up of regulatory inspections. Primary Duties: Operational Quality Management : Overseeing the strategic implementation of ` quality … more
- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position ... will report to the Director , Engineering and will be a member of the...role may support facility operations, process development activities, support compliance investigations/change management , author GMP documentation and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing environment. Experience supporting compliance investigations and change management . Experience working with Quality systems. Experience working ... to lead and support facility operations, process development activities, compliance investigations/change management , authoring of GMP documentation, 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 ... with cross-functional development teams to enable pipeline decisions.- The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports...in support of a proactive quality risk management process.Interact with the audit and compliance … more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... project CQV and IT teams.Establish GxP systems in the facility: Change Management , Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role...global line management expertise; experience of performance management and development of Director + level staff… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... The position holder will require strong skills in continuous improvement, project management , change management and risk management .Responsibilities Project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submissionManage CRO to ensure high quality compound and multi-compound level deliverablesLead the development of global harmonization ... of programming processes supporting global submissionResponsibilities - Statistical Programming Management : Coordinates outsourced statistical programming of analysis data sets… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality ... by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards (improving quality /inspection readiness,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... SAS and R. The position will require proven skills in continuous improvement, project management , change management , and risk management . The position will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance … more
