- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas of potential non-compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation , in line with company -wide policy and ... function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This… more
- Raytheon (Tucson, AZ)
- …to specification RF productsExperience creating and presenting professional level design documentation to company leadership and program customersCreo Simulate ... but not limited to, individual performance, business unit performance, and/or the company 's performance.This role is a US-based role. If the successful candidate… more
- Merck & Co. (Millsboro, DE)
- …integrity, diversified experiences, and a passion for improving animal health. Our company , consistently cited as a great place to work, discovers, develops, ... and Standard Operating Procedures and adhere to all safety and company policies while performing advanced laboratory services in various manufacturing areas.… more
- Merck & Co. (Millsboro, DE)
- …integrity, diversified experiences, and a passion for improving animal health. Our company , consistently cited as a great place to work, discovers, develops, ... and Standard Operating Procedures and adhere to all safety and company policies while performing advanced laboratory services in various manufacturing areas.… more
- Merck & Co. (Rahway, NJ)
- …to GMP procedures, strong attention to detail in completing GMP documentation , proficiency in electronic systems, and participation in continuous improvement ... transports required processing equipment, materials, supplies, and products.Executes all documentation and clerical functions necessary to maintain good manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Affairs, CMR, and other local and headquarter departments to accomplish company goals. External relationships may include interaction with FDA personnel regarding ... Liaison between NNI and NNAS departments for preparation of documentation necessary for submission of applications Maintain meeting ...of factors. This position is also eligible for a company bonus based on individual and company … more
- Merck & Co. (Rahway, NJ)
- …to GMP procedures, strong attention to detail in completing GMP documentation , proficiency in electronic systems, and participation in continuous improvement ... transports required processing equipment, materials, supplies, and products.Executes all documentation and clerical functions necessary to maintain good manufacturing… more
- Merck & Co. (Boston, MA)
- …to provide strategic guidance, ensuring that tools fit seamlessly within the company 's ecosystem and are effectively integrated with upstream and downstream tools. ... approaches for accelerating drug discoveryCreate and maintain the required documentation including Software Development Lifecycle (SDLC) deliverables (GxP and… more
- Eisai, Inc (Nutley, NJ)
- …caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined timelinesPerforms eTMF internal reviews,… more
- Eisai, Inc (Exton, PA)
- …caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …all positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Guaranteed 8% 401K contribution ... plus individual company match option 14 weeks Paid Parental Leave Free...to support manufacturing operations. Focus areas may include Training, Documentation , Deviations, Change Control and Projects. Drives the coordination… more
- Merck & Co. (Rahway, NJ)
- …setting of objectives, budget, resources, timelines, and the study protocol/related documentation .Provide overall leadership and support to the study team. Identify ... of the study (budgets and agreements) with the applicable laws and our Company 's policies and procedures - Plan and coordinate the monitoring and data management… more
- Merck & Co. (Rahway, NJ)
- …Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance with ... Medical Writer is responsible for developing informed consent deliverables per company process and standards, ensuring compliance with internal policy, regulatory… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …all positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Guaranteed 8% 401K contribution ... plus individual company match option 14 weeks Paid Parental Leave Free...in accordance with written procedures. Ensures all calibrations and documentation are in accordance with cGMP, NNUSBPI, and corporate… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …all positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Guaranteed 8% 401K contribution ... plus individual company match option 14 weeks Paid Parental Leave Free...day to day execution of validation activities, and related documentation /technical writing overseen by support of more senior Validation… more
- Merck & Co. (Rahway, NJ)
- …a smooth and clear path to successful PPQs and BLAs for the company 's pipeline.Manage large multifaceted projects as the leader of a cross-functional team.-Ensures ... independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience with… more
- Merck & Co. (Durham, NC)
- …columns, washers, autoclaves, or Clean-In-Place (CIP) systems.Compliance and Documentation :Takes ownership of cGMP compliance, ensuring adherence to Standard ... Operating Procedures (SOPs), maintenance task lists, and proper documentation .Proactively identifies and resolves compliance issues in the assigned suite, escalating… more
- Genmab (NJ)
- …smooth trial operations. The Sr CTA assists with study documentation , regulatory compliance, communication between stakeholders, and overall trial coordination. ... status updatesPlans and Resource Management:Organize and track clinical trial documentation and reportsAssist in preparation of reports, presentations, and… more
- Merck & Co. (Durham, NC)
- …subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees ... and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control… more
- Merck & Co. (Durham, NC)
- …Division sites. Duties will include system (Seeq) configuration, testing, and documentation , along with responding to support and enhancement requests from site ... & Innovative mindset- Expertise in authoring and executing technical documentation following industry standards and methodologies (SDLC, AGILE)- Excellent… more
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