- Merck & Co. (Rahway, NJ)
- …and various Divisions and functional areas to execute a robust Enterprise Risk Management programWorks with Relationship Managers from across the enterprise ... Third Party Risk questions during auditsEnsures appropriate escalation of risk management gaps, issues, and concerns to managementManages activities related… more
- 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)
- …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)
- …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)
- …purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe ... CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other… 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)
- …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)
- …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)
- …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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …met.Hold comment resolution meetings, as needed.Partner with CQM to develop a strategy to help address facilitation of risk -based periodic review/update cycles ... Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management , will be accountable for the authoring and lifecycle management… 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
- 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)
- …multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical ... with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning,… more
