- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible...US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders… more
- Aequor (Seattle, WA)
- Job Description: Position: Technical Project Manager Location: Seattle WA Top Skills: 5&plus years' experience in bio tech/life sciences project management; ... with end-to-end CMC drug development. Familiarity with alliance management Job Description The Technical Project Manager (PM) will be a key member of the Cell… more
- Merck & Co. (Rahway, NJ)
- …to the project . This is an unmatched opportunity to build your career as a project manager in a highly complex and important field. You will be given the ... well as alignment with Finance, IT, and functional area operations groups within Merck. -Your Fellowship ProjectWe are seeking...our impact to the business. Direct experience as a project manager for a development pipeline asset.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... (IR) and pre-approval Inspection preparation activities for global clinical operations , responsible for representing the GCO-CQM inspection readiness within the… more
- Merck & Co. (Durham, NC)
- …supply to customers and patients on time, every time, across the globe.The Manager , Quality Operations (QO) Microbiology will be responsible for leading and ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team ... effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation platform that integrates with MES systems… more
- Merck & Co. (Rahway, NJ)
- …Main Point of Contact (POC) for assigned protocols and link between Country Operations -and clinical trial team (CTT).- Responsible for project management of the ... DescriptionThis role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with ICH/GCP… more
- Merck & Co. (Rahway, NJ)
- …Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the ... Operations .Collaborates internally with HQ functions, regional and local operations , EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Aequor (Thousand Oaks, CA)
- …Able to manage performance issues and conflict Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact ... skillsets. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility FUNCTIONS May perform or oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Merck & Co. (Durham, NC)
- …and embraces an inclusive team culture including significant interaction with Operations , Quality, Automation, Technology, and other groups as required. Primary ... participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables.Hire, develop, motivate, and manage a team… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will assist with the development and ... education of infusion centers. This work stream will involve partnering with our operations team to manage the operation and logistics associated with the CE… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations . Experience in training, process improvement, and project management… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations of the LBRI Office of ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and… more
- Merck & Co. (Rahway, NJ)
- …the data.Compare independently entered data and collaborate with the Clinical Research Manager (CRM) to resolve any data entry differences.Collaborate with CRM and ... as protect company intellectual property.Collaborate with Medical researchers, Veterinarians, Project Managers, Laboratory Scientists, Clinical Research Managers, Clinical Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be ... as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
