- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Genmab (NJ)
- …readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight ... feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director , Utilities Electrical Engineer is a member of the Plant Engineering team providing technical support to the Durham Site.- ... procedures, engineering design guidelines and business plan; receives guidance from manager when necessary.Provides & Implements technical guidance to given tasks,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more
- Merck & Co. (Durham, NC)
- …Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs. Develop and maintain positive rapport and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs… more
- Genmab (NJ)
- …and tactical operational plans aligned to the commercial and regulatory objectives.Excellent stakeholder management, concise written communication, ability to ... of the external environment may impact their area of responsibility. People manager : Lead a small/ local team to ensure oversight of deliverables, development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Merck & Co. (Durham, NC)
- …procedures and business plan - Receives guidance and oversight from Operations Associate Director and DirectorInterprets client and/or customer needs and ... the design and construction of the facility, the Operations Manager will play a critical role in supporting the...and any action plans to address gaps to the Associate Director and/or Director -… more
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