- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical… 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
- 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 ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Director ( Sr . Principal Scientist) has primary responsibility ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing to manage clinical development projects; and assist the Senior /Executive Clinical Director /Vice-President in ensuring that appropriate corporate ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build… more
- Merck & Co. (Rahway, NJ)
- …results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial ... writers and specialists, engage in external activities to align the company with regulatory changes, act as the point of contact for external inquiries related to… more
- Merck & Co. (Rahway, NJ)
- …and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Merck & Co. (Rahway, NJ)
- …continued R&D and drive access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company could be an ideal ... areas of the business including discovery, development, manufacturing, and supply, regulatory , business development, commercial groups, and other legal functions . -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In ... collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy...activities and project level oversight including end to end risk -based deployment in relation to GxP QA activities. Involve… more
- Merck & Co. (Rahway, NJ)
- …develop a breadth of experience including finance, accounting, analytics, risk management, and special project opportunities.Corporate Audit and Assurance Services ... allow individuals to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our global business… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be ... statistics, and manufacturing to manage clinical development projectsAssist the Senior /Executive Director in ensuring that appropriate Corporate personnel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… 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 ... respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change ... in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical...MSAT at joint quality and CMC committeesPartner closely with senior Janssen leadership to achieve global alignment on all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …number of internal and external functions within NNI including; Brand Teams; VP, PCOR; Director , Pricing and Market Access Insights; Sr . Director , Strategic ... Planning and Modeling. The Advisory is led by a director and structured to act as a hub, bringing...key stakeholders Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ultimately negotiated with PBM/payer customers. Relationships Reports to the Executive Director , Strategic Pricing & Contracting. Responsible for leading a team of ... contracts to customers Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and under-performing contracts… more
