- Merck & Co. (Rahway, NJ)
- …production operations, device development and commercialization, leading cross-functional product development teams, or equivalent. Strong leadership skills, ... of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for packaging … more
- Merck & Co. (Rahway, NJ)
- …Strategic Oversight:Provide deep subject matter expertise in the design, development , and manufacturing of Autoinjectors, ensuring compliance with ... :Collaborate closely with R&D and Manufacturing regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing… more
- Merck & Co. (Rahway, NJ)
- …lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal ... stakeholders, including packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, and… more
- Merck & Co. (Rahway, NJ)
- …lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal ... stakeholders, including packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, and… more
- Merck & Co. (Rahway, NJ)
- …trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and ... container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support...matter expertise in packaging and/or medical device and combination product components as well as development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tool(s).Perform monitoring and tracking of the signal workflow to ensure compliance with procedural documents.When required, assist the product safety ... in the appropriate tool (eg, disproportionality assessments).This individual will ensure compliance with applicable domestic and international regulations and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team, ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, Audit and Compliance , QMS QA, Development QA, and PVQA) to address GxP-related issues ... audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the… more
- Merck & Co. (Cincinnati, OH)
- …RMSDs provide Scientific Leaders (SLs) balanced, factual, scientific information about non- product areas of interest to our Company and responds to scientific ... Independent Investigator Study Programs as prioritized and requested by Research and Development (R&D) leadership. -Virology RMSDs reports to the Regional RMSD Team… more
- Merck & Co. (Rahway, NJ)
- …for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims ... real-world distribution experience to enable translation into standard work development for distribution related characterization across packaging platforms to… more
- Insmed Incorporated (San Diego, CA)
- …risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with ... regulatory review of documentation prepared by other technical functions supporting product development activities (eg, clinical protocols, clinical study… more
- Merck & Co. (Rahway, NJ)
- …for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to ... technical staff, fostering a culture of continuous improvement.-Deliver the development , design, construction, qualification/ validation and/or initial operation of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with the manufacture of product Support in-process activities and product development when instructed by supervisor Incorporate pre-planned process ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This… more
- Merck & Co. (Rahway, NJ)
- …for which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant regulations , policies, and proceduresSame/similar designation ... of assigned productsAllocation of new product activated in PV-Works to the applicable product familyRisk management for assigned productsParticipation in signal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Taiho Oncology (Charlotte, NC)
- …evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower ... information on Taiho oncology products and services. The OAM will disseminate product , disease state, and fact statements about other products, across multiple… more
- Aequor (Golden Valley, MN)
- …reporting to certifiers as required. Partner with Labeling to guide the product development process (new and reformulated products) to ensure ... ingredient information, final formula, mock labels, plant documents) to assure compliance with regulations (USDA Organic), third-party certification standards… more
- Taiho Oncology (New York, NY)
- …evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower ... will be instrumental in promoting Taiho Oncology Inc's approved product line to our external customers, ensuring high visibility...our legacy". Serves as a role model for corporate compliance and holds region accountable for compliance … more
- Eisai, Inc (Pittsburgh, PA)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... and nurses, etc. learn about the efficacy and safety of Eisai's product (s) consistent with FDA approved label. Works with office management to provide… more
- Merck & Co. (GA)
- …with a primary focus on the beef industry.Collaborate with research and development teams in evaluating potential product areas.Collaborate with Business ... providing technical support for Ruminant products and programs, including response to product inquiries and adverse reports in accordance with internal, FDA, CFIA… more
- Merck & Co. (Rahway, NJ)
- …in their HTA submissions.The Executive Director is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure ... Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Ophthalmology, Outcomes Research, Product Development Lifecycle, Social Collaboration, Stakeholder Relationship… more
