- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in compliance and meets Novo Nordisk's business standards Risk management : Assessing and mitigating risks associated with operations, implementing measures and ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management : Build strong internal and external… more
- Taiho Oncology (Dallas, TX)
- Regional Business Director - Southwest Dallas, TX, USA Denver, CO, USA Req #370 Thursday, May 16, 2024 Looking for a chance to make a real difference in the oncology ... have high visibility within the organization. The Regional Business Director RBD will coach and develop the Oncology Account...our legacy". Serves as a role model for corporate compliance and holds region accountable for compliance … more
- Merck & Co. (Durham, NC)
- …, strategy development, development/revision of standard operating procedures, compliance -based projects.Lead, facilitate and participate on cross-functional teams ... with our incredibly high standards of quality. The Quality Assurance Associate Director will provide critical support in Teknika's continued efforts with supplying… 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 ... Acts as point of contact for cross-functional teams on global labeling issues . Based on timelines or resources, may assist another Global Labeling Lead… 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
- 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
- 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
- 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
- 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …IT. Strong analytical skills and the ability to manage complex change management issues are required for success in this position.Responsibilities ... of our medicines, vaccines, and Animal Health products.Position Description: Associate Director , Software Asset Management (SAM)The Associate Director ,… more
- Merck & Co. (Rahway, NJ)
- …partners in facilitating coordinated process and country delivery.Escalates site performance issues to CRM and CRD/TA-Head.People and Resource Management :Manages ... develop risk management and mitigation plans in the country and-resolve issues locally. He/she is an independent decision maker with a clear understanding.of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key internal and external stakeholders communicating project status, escalating issues , and troubleshooting routine inquiries. Expert level written and verbal ... communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important. Outside… more
- Novo Nordisk Inc. (Milwaukee, WI)
- …working practices Complies with all guidelines, policies, legal, regulatory, and compliance requirements Ensures effective administrative management of regional ... maintains medical (territory and account) plans in coordination with his/er Field Director . Relationships Position reports to Field Director /Sr Field Director… more
