- Merck & Co. (Rahway, NJ)
- … therapeutic area and team leading to global innovative and accelerated regulatory strategy and marketing authorizations for: Cardiovascular & Respiratory, ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy .Providing quality advice to… more
- Merck & Co. (Rahway, NJ)
- …skills used in drug development through assisting in ensuring project schedules and risk management plans are fully developed and updated, governance contracts ... skills used in drug development through assisting in ensuring project schedules and risk management plans are fully developed and updated, governance contracts… more
- Merck & Co. (Rahway, NJ)
- …and tools.Proactively resolve project obstacles and challenges and communicate device development strategy , design controls and risk management approaches ... manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical… more
- Merck & Co. (Rahway, NJ)
- …plans, strategy development, launch and marketing execution and budget management .Ensure planning and readiness for senior business and strategy reviews ... input on such activities as: target product profile development, global regulatory filing strategy , labeling, launch readiness reviews, organized customer… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... data in context of broader process and product development, control strategy , and specifications-setting.-Deep working knowledge of regulatory guidance and… more
- Merck & Co. (Rahway, NJ)
- …will be responsible for developing and leading the digital pathology strategy , market development, and global commercialization of digital pathology algorithm tools ... internal stakeholders across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic & device… more
- Merck & Co. (Rahway, NJ)
- …both personally and through mentorship of others, and in driving the scientific strategy of the CBT group. The Senior Principal Scientist manages and prioritizes a ... and characterization, scale-up and activities to support technology transfer and regulatory filings.The CBT group is an interdisciplinary team responsible for the… more
- Merck & Co. (Rahway, NJ)
- …for non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality, and our ... filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an… more
- Merck & Co. (Rahway, NJ)
- …Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and strategy , bridging the continuum from Discovery Research through Late-Stage Clinical ... early clinical space, determining and implementing the initial clinical strategy through proof-of-concept/pharmacology/principle and the transition from early to… more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- …scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems ... technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.--An established reputation for scientific… more
- Merck & Co. (Rahway, NJ)
- …QP2 -IO on Oncology development teams. Framing critical questions and strategy for optimizing model-based analyses on programs. Developing and executing model-based ... proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring… more
- Merck & Co. (Rahway, NJ)
- …(AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy , development, and life-cycle management activities in the ... functions and processes relevant to drug development, and project management principles as applicable to the pharmaceutical industry.Primary Responsibilities:Leads… more
- Merck & Co. (Rahway, NJ)
- …(GI) cancer program; heavy emphasis on milestone communications ( regulatory approvals, data releases, medical meeting communications).Responsible for communication ... in alignment with the company's corporate narrative and Global Oncology business strategy while continuously partnering with Global & US Oncology marketing leaders… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite and global strategy .Educate end-users on IT compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …requirements and commercialization goals in collaboration with R&D Pipeline Optimization and Risk Management : Advise annual planning for early products and ... as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic...for pipeline assets. Lead early product component of lifecycle management strategy utilizing "one impact planning". Proactively… more
- Merck & Co. (Rahway, NJ)
- …and SAP Development.- They will also have responsibility for the end-to-end Upgrade strategy from roadmap to execution for the entire SAP Ecosystem (private cloud ... professional development opportunities to team members.SAP Basis DEV/OPSOversee the management and maintenance of the SAP technical infrastructure.Ensure system… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the respective PV inspections in alignment with regulatory and company strategy .Act as the management representative for all key health authority inspections ... impacting products from a quality perspective. Provide updates to management on MTP strategy for PV QA...the GvP modules in support of a proactive quality risk management process.Interact with the audit and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project management , change management , and risk management . Responsibilities Leadership, Direction, and Strategy :Establishes Data Management ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This… more
