- Merck & Co. (Rahway, NJ)
- …and executing CMC development plans.Under the guidance of the CIPM Director & Portfolio Lead , the core responsibility of this individual will be to lead project ... programs in harmony with the portfolio. In addition, the Senior Specialist will be expected to participate in development...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:Case review/approval for assigned ... external stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant… more
- Eisai, Inc (Omaha, NE)
- …want to hear from you. Job Summary The Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) is a field-facing representative of US Medical ... assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr. MSL activities, as… more
- Genmab (NJ)
- …with organizational goals for clinical trial delivery.In this leadership role, you will lead a team of site managers to drive high-quality clinical trial ... collaborating with leadership team across Genmab and CROs to optimize trial execution. Lead implementation of site management processes and frameworks that… more
- Merck & Co. (Rahway, NJ)
- …GxP (as applicable) and other regulatory requirements. Lead the operation of the site BAS and HVAC control systems . Manage the development and oversight of ... at the Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions… more
- Merck & Co. (North Wales, PA)
- …Medical strategy and executionPrimary Responsibilities:Leadership and ManagementServes as a senior leader in the USMA organization, sets the strategic direction ... TA aligned deliverables that align with V&I Goals and serves as the Lead for the US Medical Affairs Team (MAT) meetings.Establish and maintain strategic partnerships… more
- Merck & Co. (Millsboro, DE)
- …(ABR) processes.Present operational supply metrics and strategic supply outlook to senior stakeholders.Ensure site readiness and timeline adherence through ... Pit, and Transfer meetings.Drive annual volume and timing budget planning.Oversee inter- site product shipment planning and performance tracking. Lead mid-term… more
- Merck & Co. (Rahway, NJ)
- …our Device Development & Technology (DD&T) organization to serve as a senior technical subject matter-expert and advisor for our Autoinjector platform. This role's ... seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges related to design,… more
- Merck & Co. (Rahway, NJ)
- …the global businessKey responsibilities include but are not limited to the following: Lead enterprise strategy assessment and planning to define and articulate the ... breakout sessions; Analyze outcomes and present insights and next steps to stakeholders. Lead the integration and alignment of strategy processes into business and… more
- Repligen (Waltham, MA)
- …This leader must be experienced in the development of Quality Management Systems and have a passion for continuous improvement and coaching teams.ResponsibilitiesAct ... as Global QMS system owner. Lead Global QMS process development, SOP periodic reviews, &...Training Snr Manager, Global Doc Control Snr Manager, QA Site leaders and Quality associates responsible for training administration… more