- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight (CTOR&O), will collaborate with the Head, ... monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities:Clinical Trial Operational Risk (CTOR) Management:Build and manage GCO CTOR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle management of GCO ... and ownership (design RM oversight tools, management, and maintenance), and provide day-to-day operational risk support to study teams and their line management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategic planning efforts and will be responsible to facilitate continuous improvement and operational excellence for Global CR2 across all the three regions of ... infrastructure, budget and non project initiatives. The Senior Director, Global Head of CR2 Project Management & Operational...and track the hiring timeline according to plan, identify risk or gap for timely escalation and develop contingency… more
- Merck & Co. (North Wales, PA)
- …and acquisition (M&A) projects.This role will lead collaboration efforts, support and lead global projects in relation to:QUALITY & COMPLIANCE ACROSS GLOBAL ... and improvement. Global roll out of new initiatives supporting CAPAs, compliance improvements and others.Ensures compliance and alignment with GCD model… more
- Merck & Co. (Rahway, NJ)
- …environment, leaning into areas of talent management and succession planning, operational efficiency and compliance , and external collaboration and influence ... Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for representing the GCO-CQM inspection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require the Sr. CSM to take the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director, Global Payroll Strategy and US Payroll Leader has responsibility for the delivery of HR payroll for approximately 26,000 US employees as ... well as Global Payroll Strategy impacting employees globally.- The role is...It will be expected that the role balances delivery, operational efficiency and elevates the employee and HR experience.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study level with responsibility for… more
- Merck & Co. (Durham, NC)
- …a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this ... new facility is fully operational , we will triple our current manufacturing capacity, which...project to provide support to process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as ... an environment of mutual respect, encouragement and teamwork.- As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality, and budget management Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The ... integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.We know that our people are the key to our success, which… more
- Merck & Co. (Durham, NC)
- …external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply ... for a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new… more
- Merck & Co. (Durham, NC)
- …the Operations Manager will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the ... facility.Leads and provides input into continuous improvement opportunities.Accountability - Operational LeadershipEnsure that Shift(s) objectives are achieved while reliably… more
- Aequor (Bothell, WA)
- …Global DI program. Prepare and deliver communications to site leadership regarding risk , mitigations, data integrity metrics, and Global DI Program planning. ... experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role with at least 3&plus years in a leadership position.… more
- Merck & Co. (Durham, NC)
- …to our Manufacturing Division Durham supporting the MES application and its operational use in manufacturing production. The Sr. Specialist will partner with site ... this knowledge in own work.Understands and applies regulatory / compliance requirements.FUNCTIONAL EXPERTISE:Our Digital Manufacturing Operations Senior IT Specialist… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... and will drive the development, creation, and implementation of high quality, global , coordinated cross-functional project plans for products in accordance with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for best practices as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality, training, EHS, security ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...and be responsible for the ongoing site ramp-up, daily operational management, as well as continuous improvement of cGMP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk Management: Assessing and ... are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial risks, progress/performance, timelines, and… more
