- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of GCO including but not limited to GCO Leadership, GCO Study Management , CROs, Procurement, Legal, Compliance , Finance, Clinical Development, Global Project ... ensure full compliance with processes and requirements for investigator grant management and site payments. People Management & Resource Planning Development… more
- Merck & Co. (Rahway, NJ)
- …biopharma, the portfolios worldwide and is involved in the planning and management of the Aquaculture business performance in close collaboration with the commercial ... Development, R&D, Finance, Learning and Development, Communications, HR, Legal, Compliance .External Key ContactsKey Customers, Industry Associations, Key Opinion Leaders,Animal… 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 ... required- Proven global line management expertise; experience of performance management and development of Director + level staff required- Proven experience… more
- Merck & Co. (Rahway, NJ)
- …available which is accountable for all EHS program execution and compliance at our Manufacturing Division's Global Biologics Operations manufacturing facilities ... and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS performance objectives… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Director , Business Development Responsible for leading and executing business development and commercial activities which ... - functional areas (eg Finance, External Manufacturing, Supply Chain Management , Quality, Technology, Analytical, Commercialization and Operations), as well as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Responsible for both people and project management and is accountable to set strategy for the delivery of high quality and compliant ... cross functional scientists including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management and Statistical Programming to plan for the statistical analysis… more
- Eisai, Inc (NJ)
- …and governance meetings and lead processes improvement initiatives as required.Report to Director on issues and global strategies.Manage, mentor and develop ... want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support...providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Field Access, and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to ... senior management and requires a highly motivated individual who is...in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships… more
- Eisai, Inc (Nutley, NJ)
- …maintains reporting and validation testing standards for the department, and monitors compliance with these standards.Oversee data quality management process for ... from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director , Commercial Analytics is part of a high performing team that provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … with new and changed regulatory obligations related to Corporate Compliance . Informs management of ethics & compliance issues in a timely manner while ... on new procedures, to auditing against local and corporate policies, to reporting compliance -related issues , ECP keeps us accountable every step of the way… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Director , Medical Content & Training (MCT) Excellence and Innovation is ... identifying the latest digital tools and technologies to support MCT activities. The Director serves as primary functional partner and MCT subject matter expert for… more
- Tris Pharma (Monmouth Junction, NJ)
- …coding Experience supervising or overseeing outsourced vendor activities in compliance /regulated pharmaceutical activities People management experience Ability ... success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development, oversight, and execution ... and implement a monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures as outlined… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director , Quality Operations ... Directors to ensure transparent communication and assess any product related issues . Impact assessment includes proper evaluation for Health Authority reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …conduct, reporting, and close out) including timeline, quality, and budget management Drives and leads the successful execution of all operational components ... global clinical program using strong clinical project and program management , leadership, decision-making ability, people management , and organizational… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working with the ... clinical studies, before during and after conduct of studies, and identify/resolve issues related to study design that arise during study.Provide medical expertise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the ... high data quality and proactive detection and resolution of issues .Lead effective communications within the GPT, by interacting with...with other GxP QA functions (GMP/ IMP QA, Audit Compliance , Quality Management System [QMS] QA, PV/MA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased ... as point of contact for cross-functional teams on global labeling issues . Based on timelines or resources, may assist another Global Labeling… 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 ... quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and novel technological ... part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible… more
