- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the leadership team . Lead an enterprise cross-functional QA team to deliver state-of-the-art data -driven solutions.Design a fit-for-purpose organization ... technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team , the director oversees QA plans, promotes data governance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …deep dive as well as converse at high technical level with architects and senior scientists. Expertise in data engineering, data science, Machine Learning, ... Job DescriptionAn opportunity has arisen for a Sr. Data Scientist in the Pharmaceutical Sciences and Clinical...otherwise intractable problems faced by the business. - Our team ensures the scientific community at our company is… more
- Merck & Co. (Rahway, NJ)
- …Proven ability to collaborate with a wide variety of individuals, including senior management, stakeholders, team members, other departments and suppliers Proven ... organization grouped into centralized categories and regional operating teams.The Senior Specialist, NA Transportation Procurement is an integral role that… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team… more
- Formation Bio (New York, NY)
- …are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team ... and more efficiently.About the PositionWe are looking for a Senior Software Engineer, Applied AI to join our dynamic... Software Engineer, Applied AI to join our dynamic team at Formation Bio. As we continue to revolutionize… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality ... other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability to ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters, including performance reviews and departmental talent development.Line management and senior leadership accountabilities in CoELead a team of safety ... of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions,...resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across… more
- Merck & Co. (Rahway, NJ)
- …Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse ... target commercial product.-Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment.… more
- Merck & Co. (Rahway, NJ)
- …Business Risks, Change Management, Clinical Development, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.-...expert in a particular area of expertise.- Mentors new team members and supports staff development, as needed Demonstrates… more
- Merck & Co. (Rahway, NJ)
- …as well as the Global Centers of Excellence (COE's) and Operations Teams. The Senior Specialist will support, assess and manage new demand for business requests and ... expertise to drive performance. The ideal candidate will be an accomplished HR team member with project or operational team experience working globally.-… more
- Merck & Co. (Rahway, NJ)
- …Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse ... Job DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC… more
- Merck & Co. (Rahway, NJ)
- …business. Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant ... as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that manufacture, assemble,… more
- Eisai, Inc (Nutley, NJ)
- …hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of clinical trial execution ... with the overarching project plans established by the various International Project Team Leaders (IPTLs). This role requires a deep understanding of the entire… more
- Merck & Co. (Rahway, NJ)
- …technology.As a Business Technology Partner (BTP), you will report to the Development IT BTP lead within our company's Research Laboratory IT. You will be part of a ... team that deeply understands business strategy and creates and...& Application or Solution Architectures.Proven Ability to Collaborate and Lead : The candidate must demonstrate the ability to collaborate… more
- Merck & Co. (Rahway, NJ)
- …of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… more
