- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in ... disclosure for collection, retention, testing and retesting of samplesProject Team Participation: Provide device-specific regulatory insight/guidance during CDx Indication… more
- Merck & Co. (Rahway, NJ)
- …a subject matter expert in a particular area of expertise.- Mentors new team members and supports staff development, as needed Demonstrates high capability to solve ... best practices related to clinical supply planning and incorporate them into the team 's operations. - Focus on Customers & Patients. - Make rapid, disciplined… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member to the Global ... Project Team for late stage projects. This position manages multiple...the briefing book, to training and preparing the technical team , to authoring and finalizing the meeting minutes. This… more
- Genmab (NJ)
- …plan approval and final feasibility. KPIs developed and shared across the study team as part of year end objectives.Point of contact for assigned program and ... projects with tactical results making decisions within a defined framework, influencing team goals and usually with short term impact. Operate with understanding how… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the formation and management of the newly created TA Oncology Leadership team and in driving strategy, management and facilitation of key programs and ... capability elevation. As an integral member of the Leadership team , the position will closely collaborate with key stakeholders...tactical initiatives under the guidance of the TA Leadership team and in partnership with members of the RD… more
- Repligen (Hopkinton, IA)
- …to help navigate situations as they arise. Partner with our legal team on policy interpretation, investigations and risk mitigation. Provide data analysis and ... reporting solutions based on business needs, highlighting key trends in employee relations and actively drive proactive solutions to mitigate risk. Compliance and Risk Management Ensure all ER practices comply with federal, state and local laws and regulations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Responsibilities ... submission QAs, perform ad-hoc and exploratory analysis requested by clinical team , and support agency response or potential Advisory Committee Meeting- Develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …prioritize and balance responsibilities in accordance with business and team needs.Experience maintaining strategic direction while ensuring successful execution of ... project details.Solid interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams and at managerial levels of the organization across various functions and locations Travel:Domestic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Procurement, and other functions of the Global Corporate Planning Management team . The objective is to design and manage sustainable global train-the-trainer ... said projects, this includes working closely with the other team members also assigned to these projects.- Create the...teams, as well as Global GCPM teams, CFO Leadership team - Lead change management efforts related to Finance initiatives,… more
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