- Merck & Co. (Rahway, NJ)
- …data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be ... risks and develops appropriate mitigation strategies to ensure successful implementation of project plans.- Escalates issues through the risk log and drives… more
- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent) Our company's Device Product & Process ... device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission activities. The GRL will… more
- Eisai, Inc (Nutley, NJ)
- …a strategic, business-minded, and hands-on attorney role whose job will be to lead Eisai's privacy initiatives across the US and Canada and partner with ... enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law,...etc.) and daily business activities in compliance with state, federal and global privacy laws. Draft, review, update and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management, Regulatory Submissions, Risk Management, Stakeholder ... second generation process development and health authority licensure. - You'll lead the charge in transforming our late-stage pipeline into reality bringing… more
- Insmed Incorporated (NJ)
- …with business objectivesAs the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and recommendation ... accountable for creating a best-in-class team to plan, integrate and lead activities associated with moving Insmed's late-stage pipeline through clinical… more
- Insmed Incorporated (NJ)
- …and environmental protection for all Insmed locations.Key duties include risk assessment, developing safety policies, managing training programs, and ensuring ... compliance with regulations like OSHA, EPA, and other federal , state and local regulations.The Director will work with leadership and company employees to foster a… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Global Science & Technology Network leadership team to lead complex, site-to-site technology transfers for Animal Health vaccines across our ... grow our teams while delivering complex, strategic initiatives. Key Responsibilities Lead -and support end-to-end site-to-site technology transfers for Animal Health… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence ... across the end to end supply chain, and analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and eCTD publishing Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; ... in FDA and HC submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the team. With direction from… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution ... party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed… more
- Merck & Co. (Rahway, NJ)
- …IS Audit, Leadership, Negotiation, People Leadership, Preparation of Financial Reports, Project Risk Assessments {+ 5 more}Preferred Skills: Current Employees ... across the organization globally.Details of specific areas of responsibility are: Lead the application of accounting principles applying deep technical accounting… more
- Merck & Co. (Rahway, NJ)
- …MS Office Suite (Outlook, Word, Excel and SharePoint) and Adobe Acrobat ProStrong project management skills, including the ability to lead and oversee complex ... point for the docketing team, attorneys, and staffImmediately reports all risk management-related concerns to Senior LeadershipResponsible for the compilation of… more
- Insmed Incorporated (San Diego, CA)
- …Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team ... Provide strategic leadership and decision making on CSV strategy Develop risk -based validation strategies for system implementation and changes following CSV SOPs… more
- Insmed Incorporated (NJ)
- …and Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and ... and external partnersServe as clinical supply representative on cross-functional project and clinical strategy teams; translate protocol design into demand/supply… more
- Insmed Incorporated (NJ)
- …start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol ... trials, management of third-party vendors for clinical services, management of project timelines and deliverables. Key trial management support to the Associate… more
- Insmed Incorporated (NJ)
- …specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical/Manufacturing systems. Project lead experience preferred.Strong experience in Clinical Study ... will include, but not necessarily limited to the following: Develop risk -based validation strategies for system implementation and changes following CSV SOPs… more
