- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level handles escalated global CSPV case processing issue and handles project . This position prepares trainings, supports CAPA investigations, case review, ... oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be supporting early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part of ... Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe purpose of the Senior Director , Forecasting & Business Analytics is to lead the forecasting and financial ... and due diligence efforts and ensure tax collaboration: work directly with the BD project lead as well as legal team to proactively inform them of the timelines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...as a change agent to promote flexibility, creativity, and accountability. Project management skills, responsiveness to issues, and demonstrated passion… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... designated programs.Ensure proactive representation of Quality professionals at strategic non- project team and at MA strategic discussions.Lead the Quality Reviews… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Training functionsMust have proven people leadership experience.Must have demonstrated project management skills and experience working on global projects and ... teamsMust have proven ability to work cross-functionally within a matrixed global teams environmentMust have a broad understanding of quality management system, GxP regulations and industry trend/practiceMust have strong interpersonal skills to build… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates ... from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation : Assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participate/contribute to discussions in applicable working teams, technical teams, project teams, etc. Qualifications: Successful candidates will be able to ... Qualifications 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position has advanced skills in continuous improvement, project management, change management, and risk managementResponsibilities: Leadership, Direction, ... department level.Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (eg, operational leadership teams). Functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to ... Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Director , Global Sourcing (Direct Materials) as part of the Technical Operations team ... based in Raritan, NJ.Role OverviewThe Director , Global Sourcing (Direct Materials) is responsible for leading the design and execution of a high-performing Global… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionGlobal Project and Alliance Management (GPAM) resides within the Research and Development (R&D) organization at our Company's Research & Development ... Division. The Project , Portfolio and Alliance Managers in GPAM are core...R&D partners.Position Description/Summary:Under the broad direction of the Senior Director or Director , Strategic Alliances, the Associate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:Supports positions from Director through Vice President, as needed, and in so doing will ... provide direct assistance to the project teams, committees and the department/function.Attend GPT meetings and...efficient ways of working within GPM&L or on a project team, enhanced collaboration tools, etc.Schedule and implement on-site/off-site… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Associate Director , Global Scientific & Value Content-Healthcare Professional (AD, GSVC-HCP), position resides in the Value & ... Enterprise Leadership Responsibilities:Leads projects and solves complex problems: Oversees project management, providing solutions to complex issues, and guides… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The USMA Health Systems (HS) Director , Strategic Medical Implementation Lead, plays a critical leadership role in advancing the strategic ... across the Health Systems field medical enterprise.The USMA HS Director , Strategic Medical Implementation Lead, holds primary responsibility for integrating… more
- Merck & Co. (Rahway, NJ)
- …increasing overall operational effectiveness.We are seeking a dynamic and experienced Associate Director of Outside Counsel and Vendor Management to join our Legal ... report directly to the Chief of Staff to the General Counsel & Executive Director , Legal Operations, Innovation & Technology and will be based in Rahway, NJ.- This… more
- Merck & Co. (Rahway, NJ)
- …year of experience as a people manager leading a team.7+ years of project management experience in the development and execution of statistical analysis and ... and develop peopleExpertise managing and forecasting team's resources at the project and therapeutic area levelBroad knowledge and demonstrated experience in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Sustainability Strategy & Engagement will join the Company as a member of the Social Impact and Sustainability (SIS) function, ... sustainability, access to health, employee engagement, and ethics and values. The Associate Director will serve as a trusted advisor to business leaders , including… more
