- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems such as Sharepoint, LMS, Trackwise Digital and other quality management systems.Strong interpersonal, communication, technical writing, negotiation ... R&D PV QA organizational strategy. This position will proactively collaborate with other Global quality colleagues to drive the global QA vision and act as the US QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for ... of functions in Daiichi Sankyo (DS). Reporting to the Sr . Director , Enterprise Program Management ,...project level quality metrics. An ideal Associate Director , Program Management must have the expertise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or act as main CMC Lead of ... to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this leader enables all activities related to the successful acquisition of high- quality goods/services at the best possible prices and business terms for NNI. ... and Marketing organization Leads a team that goes beyond traditional category management functions with a significant focus on business partnership and driving value… more
- Merck & Co. (North Wales, PA)
- …Content Management , you will play a pivotal role in simplifying our Quality Management System (QMS) technology stack and enhancing user experience. This is ... an exciting opportunity to leverage your expertise in digital technologies and quality management to make a significant impact on our business operations and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …helping to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to ... management , supplier diversity required- Proven experience working with senior leadership, including C-suite executives preferred- Possess an understanding of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and...to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations, BDM and DLT members. He/she… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research...plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population...clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …Owner collaborates with stakeholders across all levels of the organization, from senior management to tactical execution- to understand customer master data ... focused on meeting business needs and maximizing value for investments.Organizational Change Management : Demonstrate and drive high- quality change management … more
- Novo Nordisk Inc. (Boulder, CO)
- …small molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development. Essential Functions Lead the ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.… more
- Merck & Co. (Rahway, NJ)
- …similar)Required Experience and Skills:10+ years biotech/pharmaceutical industry experienceProject management skills; focus on quality and ... results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial… more
- Merck & Co. (Rahway, NJ)
- …of technical experience; competence in clear concise and tactful communication with senior management , clients, peers and team members Demonstrates an executive ... and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth… more
- Merck & Co. (Durham, NC)
- …consistent with contractual requirements, while considering necessary linkages to our senior management across multiple Divisions and internal governance ... of experience with increasing responsibility in Manufacturing Operations, Supply Chain Management , Quality , Science and Technology, Global Procurement, External… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …groups and cross functional partners.Key Responsibilities Represent MSAT at joint quality and CMC committeesPartner closely with senior Janssen leadership ... in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical...participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the… more
- Merck & Co. (North Wales, PA)
- …/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific ... clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include: Collaborating cross-functionally in the development of… more
