- Insmed Incorporated (NJ)
- …are efficiently completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be ... Are you?About the Role:We are seeking a highly experienced Senior Director, DSPV Medical Safety to help us expand... authorities on safety issues for assigned products and lead the integrated safety input into all regulatory… more
- Merck & Co. (Rahway, NJ)
- …cell-line platforms. This role will be a member of the Process Automation team, reporting to the Process Automation leader. In this role, this individual will be ... Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems. Lead integration of control systems with MES, Quality, and Batch … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead ).Where ... clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The...The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …owning demand and revenue forecasts for several oncology assets and will be reporting to the Senior Director, Global Business Strategy and Analytics. Director ... of global forecasts, ensuring compliance with internal policies and external regulatory requirements. Lead audit readiness and respond to governance milestone… more
- Insmed Incorporated (NJ)
- …you?About the Role:The Director, EHS (Environmental, Health, and Safety) isa senior -level role responsible for creating and implementing programs that ensure ... workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key...of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide… more
- Insmed Incorporated (NJ)
- …serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for the company's small ... molecule pipeline. As a senior leader, you will oversee drug substance and drug...strategic leader, ensuring that development programs meet scientific, quality, regulatory , and commercial standards, while ensuring execution across internal… more
- Insmed Incorporated (NJ)
- …role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, ... Risk Management plays a critical leadership role in safeguarding that mission. Reporting directly to the Chief Information Officer, this individual is responsible… more
- Insmed Incorporated (NJ)
- …Review team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Medical Review Committee (MRC), you'll be ... ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to identify and leverage synergies across analytics teams.Responsibilities- Data-Driven Insights Reporting and trend analytics: Lead the development and ... analytical best practices. Innovative analytical methodologies led by the Medical Analytics Lead will be used to support key projects like Medical insights Mining,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Kaiser, institutions, GPOs) and other area/regional accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes ... Committee, offer development, contract development, negotiation, pre-deal forecasting and reporting of contract profitability of customer segments for all Novo… more
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- Insmed Incorporated (NJ)