- Merck & Co. (Rahway, NJ)
- …of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product and project regulatory ... all assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including ... other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, performance, and… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... 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)
- Job DescriptionJob SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof.- In this position, ... functional team.Job ResponsibilitiesResponsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:Serving as the… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Summary - This position leads the scientific -pl anning and execution of one or more clinical trials or significant aspects thereof . In this ... . - Job Responsibilities - Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s) . This may include: Serving as the … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Merck & Co. (Rahway, NJ)
- …leadMay lead team in key study planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site ... Job DescriptionThis position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will… more
- Merck & Co. (Rahway, NJ)
- … data , and mentor junior staff, ensuring excellence in execution .Enhance Process Understanding: Provide technical leadership in interpreting trends from ... Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products… more
- Merck & Co. (Rahway, NJ)
- …and Skills: Strong background in integrated analytical control strategy development and execution . Demonstrated ability to lead a technical team and develop ... 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… 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)
- …Performance Qualification and Process Simulation execution , the selected candidate will lead and contribute to the launch and regulatory certification of the ... operations group will require the individual to leverage Decision Making and Execution Excellence skills to be successful. Off-shift (2nd) work will intermittently… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... 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)
- …and analysis and reporting through all phases of development including regulatory submissionsDemonstrated history of development and execution of innovative ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …ultimately to the Global Cap Ex team, ensuring the correct sourcing and execution of projects and 100% compliance with processes and policies.The candidate will be ... (PPPs) for each capital project to ensure upfront alignment on the sourcing strategy. Lead sourcing projects to deliver optimal value to the company (cost, timelines,… more
- Merck & Co. (Rahway, NJ)
- …expected to be adept in managing work with external partners for timely execution of work.The successful candidate is expected to collaborate in a fast-paced, ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… 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)
- …& Manufacturing, in a fast-paced, multidisciplinary environment- - Participate in or lead 1) development of robust and scalable purification processes for biologics ... in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization - Advance downstream processes by… more
- Eisai, Inc (Nutley, NJ)
- …teams and leverage learnings from current PCP work to advise on long-term PCP strategy. Lead agency partners in the development and execution of the HCP messaging ... want to hear from you. The Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the… more
