- 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)
- …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)
- …skills used in drug development through assisting in ensuring project schedules and risk management plans are fully developed and updated, governance contracts ... Therapeutic Area strategies while ensuring alignment to the broader Merck Corporate strategy .-In addition, GPAM includes a Project Management Office (PMO) which… more
- Merck & Co. (Rahway, NJ)
- …for product concepts and solutions considering competitive factors, market demand, risk management , program economics, strategic fit, and operational ... by customers.Collaborate with CABU leadership team and key internal partners on the strategy , development, and management of KOLs and Advisory Board for our… more
- Merck & Co. (Rahway, NJ)
- …with one or more regulatory programs: RCRA, Title V, Process Safety Management (PSM), Industrial Hygiene, BioSafety and High- Risk Work (eg elevated work, ... project management skills, supporting multiple activities/projects simultaneously.Experience working with regulatory agencies.Demonstrated skills in complying… more
- Merck & Co. (Rahway, NJ)
- …of a team of enthusiastic scientist and engineers supporting chemical management , chemical stewardship, hazard communication, environmental risk assessment and ... management systems, hazard communication (Safety Data Sheets), environmental risk assessment, chemical stewardship teams.Engage on proposed laws, regulations,… 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)
- …playbook to scale across IT Finance team and IT Product Teams, partnering with Value Management lead in IT Strategy .Consult with teams on how to structure and ... Experience and Skills: 5+ years in Finance, business operations, business strategy , investment management , or similar fieldPlan, lead and implement… 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)
- …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)
- … regulatory frameworks and compliance standards related to identity management Excellent interpersonal, written and oral communication skills to collaborate ... end-users.- Reporting to the Product Owner of Enterprise Identity and Access Management , this position will be responsible for the daily delivery efforts of… 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
- 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
- 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)
- …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)
- …road map to meet changing regulatory and business needs.Lead remediation and risk management to assure the organization's Quality Management System is ... and collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory -related CAPAs that impact… 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or ... people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Serves ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 -… more
