- Eisai, Inc (Nutley, NJ)
- …senior leadership role responsible for overseeing all aspects of clinical trial execution within a pharmaceutical or biotechnology company. This role ensures studies ... are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers and other… more
- Eisai, Inc (Nutley, NJ)
- …that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating ... he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO...the quality of CRO deliverables and on QA of data outputs. 10%5. Functions as lead statistician… more
- Formation Bio (New York, NY)
- …and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing ... & External Partnerships Partner closely with analytical development, manufacturing, quality, and regulatory teams to ensure seamless execution of CMC plans.… more
- Merck & Co. (Rahway, NJ)
- …and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Merck & Co. (Rahway, NJ)
- …commercialization Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs ... assets Bring deep expertise in biologics DS processing (large molecule products) Lead planning, execution , analysis, and documentation of cell culture process… more
- Merck & Co. (Rahway, NJ)
- …Implement and sustain technical standardization of best practices across the network. Lead assignment execution against accelerated timelines, in a ... shake flasks, and/or 2-3L bioreactor systems.Expertise in upstream lab scale experimental execution , Design of Experiments (DOE), statistical data analysis and… more
- Merck & Co. (Rahway, NJ)
- …cell bank and working cell bank) manufacturing operationsStrong understanding of regulatory requirementsAbility to lead without authority, build trust, and ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …data entry, data review/approval, and author analytical reports or data summaries.Troubleshoot and lead any investigations associated with GMP testing ... appropriate corrective and preventative actions.Directly contributes to experimental design, execution , and data interpretation for validation studies.Support… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.In… more
- Merck & Co. (Rahway, NJ)
- …world class outcomes in the following areas:Responsible for on-time, end-to end execution of DCT deliverables including - robust processes & analytics, an integrated ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory ,… more
- Lundbeck (Bronx, NY)
- …in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with ... Planning & Account Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics, allocate resources to… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... for end-to-end technical product leadership (TPL) and oversight of the on-time execution of DCT deliverables inclusive of robust processes & analytics, an integrated… more
- Merck & Co. (Rahway, NJ)
- …Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a ... as required, proactively identifying risks and supporting all phases of execution . Conduct technical due diligence assessments and provide expert consultation on… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... PCR-based assays.Strong background in analytical control strategy development and execution .Demonstrated ability to develop talent through good mentoring skills.Demonstrated… more
- Citigroup (New York, NY)
- …functional teams within Risk on how to implement the policy standards + Assist the Data Governance Lead with managing Regulatory requests (MRIA, MRA) related ... Data Office and will support the Risk Data Governance lead in the development, adoption,...to Risk data and coordinating responses and execution plans across Functional Data teams +… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is ... critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully...the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory… more
- Citigroup (New York, NY)
- …worldwide. The Transformation Legal Group is a part of Citi's broader bank regulatory legal group and provides legal advice and counsel in connection with the ... execution and implementation of Citi's enterprise-wide risk management and...modernize how the firm operates and enable it to lead in a dynamic, competitive, and increasingly digital world.… more
