- Merck & Co. (Millsboro, DE)
- …tier meeting attendance.Category/Subcategories Stakeholder Engagement - Understand stakeholder requirements in relation to establishing supply strategy and proactive ... routine reviews and be able to translate and document Stakeholder requirements into tangible business results.Relationship Management - Work with Business… more
- Syner-G BioPharma Group (Boston, MA)
- …may be supplemented and changed as necessary.) Assist with the requirements specifications, design, functional requirements , development, commissioning, and ... of process equipment or systems for compliance with manufacturing requirements and facility fit.Lead start-up activities, including commissioning and qualification… more
- Merck & Co. (Rahway, NJ)
- …training materials in compliance with applicable SOPs, policies, and regulatory requirements . - Defines and contributes to the development of training strategies ... needed. - - Qualifications , Skills & Experience - Required Educational Requirements : Bachelor's degree in science (or equivalent eg nursing qualification )… more
- Merck & Co. (Omaha, NE)
- …Trade Compliance Team is primarily responsible for identifying trade compliance requirements , supporting various our Company Animal Health locations with trade ... trade compliance training materials related to the GTC Global Standards and requirements , and support training for involved employees using the best possible… more
- Merck & Co. (Rahway, NJ)
- …inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971). - ... and manufactured in accordance with regulatory, company, and customer requirements . - Principal Responsibilities Lead/Support continuous improvement initiatives for… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry ... standardsMinimum Education Requirements and Experience: Bachelor of Science (BS) in packaging,...with an ability to interrogate the science, identify true requirements , and detect critical flaws including ability to determine… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry ... standards Minimum Education Requirements and Experience: Bachelor of Science (BS) in packaging,...with an ability to interrogate the science, identify true requirements , and detect critical flaws including ability to determine… more
- Merck & Co. (North Wales, PA)
- …availability within DHH. Travel may be required ( - Education Minimum Requirements :- Undergraduate degree in related discipline required MBA or Master's degree in ... and break down business questions into specific, tangible hypotheses and requirements to guide analysis. Excellent problem-solving skills with an appreciation for… more
- Merck & Co. (North Wales, PA)
- …availability within DHH.Travel may be required ( -- Education Minimum Requirements :- Undergraduate degree in related discipline requiredMBA or Master's degree in ... and break down business questions into specific, tangible hypotheses and requirements to guide analysis. Excellent problem-solving skills with an appreciation for… more
- Merck & Co. (Durham, NC)
- …and proficiency in interpreting and applying domestic and international regulatory requirements Knowledge of Quality Systems within a GMP environment Demonstrated ... Distribution, Data Integrity, Automation) Knowledge of QBD development & submission requirements , as applicable to site Ability to lead, motivate, develop and… more
- Merck & Co. (Rahway, NJ)
- …and inform product decisions. Translate user insights into clear requirements , hypotheses and minimal viable experiments.Execution & Delivery Maintain and ... features and user stories which align with the overall roadmap and serve as requirements for the delivery squad Partner with squad members including but not limited… more
- Merck & Co. (Rahway, NJ)
- …teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance ... programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA assemblyExpert knowledge in… more
- Merck & Co. (Rahway, NJ)
- …Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and the ... of each study.Ensure that the study is conducted according to legal requirements , GCP, and the applicable internal policies and procedures.Prepare the Final Study… more
- Merck & Co. (Rahway, NJ)
- …active equipment and infrastructure.Ensure consistency in equipment and infrastructure requirements globallyProactively evaluate, manage, and mitigate impact of new ... safety & quality requirements on GCS equipment and infrastructureSupport Permanent Inspection Readiness and Continuous Improvement expectations.Manage global small… more
- Merck & Co. (Rahway, NJ)
- …internal CMC community, collaborate with cross-functional teams to gather business requirements , and coordinate with IT, Research, and Manufacturing to capture ... operations, technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation Hands-on experience in… more
- Merck & Co. (North Wales, PA)
- …programming staff to ensure that all programs meet analysis requirements , internal standard operating procedures, and external regulatory requirementsEvaluates ... data processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral… more
- Merck & Co. (Rahway, NJ)
- …in accordance with applicable regulatory, quality, company, and customer requirements .-This position will lead cross-functional development teams within and external ... Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for ... or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences… more
- Merck & Co. (Rahway, NJ)
- …engineering and packaging science is applied to deliverables. Minimum Education Requirements and Experience: Bachelor of Science (BS) in packaging/ mechanical/ ... skills with an ability to determine interrogate the science, identify true requirements , and detect critical flaws including the ability to determine areas of… more
- Merck & Co. (North Wales, PA)
- …information regarding approved company products, disease, and marketplaceMinimum Requirements :Bachelor's degree or equivalent; 3+ years of pharmaceutical/biotech or ... in the assigned territory.Candidate must possess a valid driver's license.Preferred Requirements :Pulmonology experience is a plus; experience with specialty HCPs in… more
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