- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position with ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred Experience Qualifications- 7+ years of professional pharmaceutical experience in project management and operational support role and relevant ... collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will...in close collaboration with the QA Training and Documentation management team. This position will take direction from global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-regional senior leaders with collaborative mindset required- Prior experience in project management or leading change management initiatives ... and people with disabilities.Summary Reporting to the Disease Area Strategy Team (DAST) Lead for GYN Cancer, this position...critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Job Summary: The position will define and oversee the translational strategy /plan for oncology therapeutic program/s in global R&D. The successful candidate will ... experts both in the US and Japan, for a tight alignment with the Global Project Team. In addition, he or she will interact with the Companion Diagnostics Lead,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry (preferably in a global company).10+ years of expertise in project management , process, product, and/or analytical development activities and ... (or have subordinates develop) activity plan, and budget for project in alignment with Unit strategy , plan,...at least 2+ years in a direct or matrix management position of a CMC-related function in the pharmaceutical/biopharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have the expertise and leadership to manage ... around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position...business acumen who is skilled at both program and project management . This role is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Project Teams, possibly as Global Clinical Lead. Responsibilities:Study Strategy : Clinical study leader (CSL) or major scientific/medical contributor; For large ... pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Science Strategy . In conjunction with Global RD Finance, Global Project Management , HR, manage the workforce planning for Global Clinical Science, ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills with demonstrated ability to build collaborative relationshipsStrong project management skillsOrganizational awareness (eg inter-relationships of ... to drive the vision and implementation of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Work closely with study site operational staff to ensure timely and accurate updates. Project Management : Demonstrate advanced project management skills, ... research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to review all congress initiatives, timelines and deadlines for content and execution. Project management to ensure all business-critical deadlines are met for ... areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …priorities simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product, and/or analytical development activities and ... or act as main CMC Lead of an early-stage project . He/she has responsibility for the overall strategy...to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy : Clinical study leader (CSL) or major scientific/medical contributor; For large ... pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred- Strong project management experience and ability to manage and execute multiple ... ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead. This position leads labeling meetings for preparation of responses to comments… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management . Develop a ... functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Commercial & Strategy , Global Forecasting & Insights and Global Project Management . Successful execution will involve working cross-functionally to gather ... and develop comprehensive opportunity assessments consistent with our corporate business development strategy . This position may lead a small team and will report to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic direction ... Reviews patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy in collaboration with Translational… more
