- Merck & Co. (Rahway, NJ)
- Job DescriptionThe GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... in GRACS for business process management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for… more
- Merck & Co. (Rahway, NJ)
- …technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the Director, Engineering and will be a ... of new technologies/capabilities, execution of capital and non-capital improvement projects , and interfacing with the automation system assets spanning production,… more
- Merck & Co. (Rahway, NJ)
- …teams.Streamline and automate EHS processes through the implementation of digital solutions. Lead and participate in digital transformation projects to develop ... analytical and problem-solving skills.Direct experience implementing and sustaining EHS programs. Project management skills with the ability to lead … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Scientist, Microbiology (Lab Lead ) - Analytical Research & Development (Onsite) Small Molecule Analytical Research and ... the rapidly growing pipeline via collaboration with stakeholders for various projects , routine testing, validations, and implementation of alternate micro methods.… more
- Merck & Co. (Rahway, NJ)
- …Engineering will serve as a business representative in the FLEx Sterile Expansion Project which is currently in Conceptual Design Phase (also known as Front End ... Loading Phase II, FEL-2).- The FLEx Sterile Expansion Project is intended to more than double the expected capacity of the existing FLEx Sterile Facility by way of… more
- Merck & Co. (Rahway, NJ)
- …to function as an independent contributor, supporting global and site-specific projects , including those related to Combination Products and Drug Delivery Systems.- ... highest regard for our Company divisional and local site procedures for safety , quality, and regulatory compliance.Understand the big picture, and how activities… 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 ... technical detailBuilds collaborations across internal departments and key stakeholders.Ability to lead and champion organizational structure and be a change agent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function. Deliver the project according to plan within ... of professional pharmaceutical/academia/healthcar industry experience required- Proven expertise in project management required- Strong knowledge of patient safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to ... collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position...Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally ... Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects . Candidates should have a comprehensive understanding of clinical trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities and interdependencies for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical ... amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leaders.- Contribute to Clinical Development initiatives, global education, and process development projects , as required. May serve on or lead global ... disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical...clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and ... multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global submission.Responsibilities- Statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects . This ... multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The primary responsibilities of Clinical Pharmacology are to establish PK/PD/efficacy/ safety relationships in the clinical setting, to drive the development ... and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of study designs, protocols, reviews and authoring reports and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …data analysis to support establishment and monitoring of change control for operations. Lead cross functional team meetings to prioritize updates to MBRs/ EBR/MES ... writers to maintain timelines.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Drive change controls to ensure on… more
- HITT Contracting (New York, NY)
- … lead experience preferred Previous experience in a superintendent or project lead experience preferredAbility to master sector/ project -specific software ... the project on site consistent with the project schedule and HITT safety and quality...for temporary facilities/utilities for the site, and identifying long lead items that need to be expeditedCollaborate with the… more
- Fidelity TalentSource LLC (New York, NY)
- … project plans and status logs with completion times and issue resolutions/decisionsAlerting lead consultant when project timing and scope are not in line ... or retiree health care solutions. You will support H&W Benefits Consulting projects , coaches other associates and promotes teamwork. The Expertise and Skills We… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …permits, confined space entry programs, emergency response programs and other safety programsAssists in the creation, tracking and completion of maintenance related ... experience working and leading in a matrix environmentAbility to lead with influencecGMP manufacturingMaintenance, metrology, and facilities managementComputerized maintenance… more
