- Merck & Co. (Rahway, NJ)
- …and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively ... well as collaborative, and innovative culture in GRACS for business process management and continuous improvement.-Establish and lead assigned domain Global… more
- Merck & Co. (Philadelphia, PA)
- …Labor and Human Rights Audit Program as neededEnsures appropriate escalation of risk management gaps, issues, and concerns to managementManages activities ... Matter Expert (SME), leading system administration, answering user questions, and management of external risk data providers. Responsibilities also extend… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... Lead is established, take main responsibility for CMC lead . Provide operational coordination and management to...1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The therapeutic area Operations Lead is responsible for supporting the therapeutic area One Impact Planning process, ... the business. Relationships Reports to the US Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including sales, marketing, medical… more
- Merck & Co. (Durham, NC)
- …commissioning and qualification, licensure, and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.This… more
- Merck & Co. (Durham, NC)
- …peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. ... - The Lead Maintenance Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Merck & Co. (South San Francisco, CA)
- …Biosciences (Pharmacology) department. The successful candidate will have direct line management of a research team responsible for the design, execution, and ... as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area… more
- Merck & Co. (Rahway, NJ)
- …the activities of lab staff, including scheduling, training, and performance management .Ensure adherence to safety protocols and regulatory requirements within ... Job DescriptionPosition Description: Senior Scientist, Microbiology (Lab Lead ) - Analytical Research & Development (Onsite) Small Molecule Analytical Research and… more
- Merck & Co. (Durham, NC)
- …in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The ... Lead Maintenance Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility… more
- Merck & Co. (Rahway, NJ)
- …database standards, SOPs, and Process Guidelines. You will have the opportunity to lead and participate in the review of electronic case report forms (eCRF) and ... scripts that facilitate the transfer of electronic data files into the Clinical Data Management System (CDMS). A key aspect of your role will be to collaborate with… more
- Merck & Co. (Rahway, NJ)
- …state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP Technology.-They ... Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology… more
- Merck & Co. (Rahway, NJ)
- …another's thinking and approach problems collectively. As an ERP Direct Procurement Lead , you will: Design and shape our Company's Direct Procurement solution ... globally, in partnership with the Global Supplier Management Value Team. Manage and oversee the SAP configuration for Direct Procurement. Ability to collaborate with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- …and 21 CFR 820 compliance technical documents, design controls, device risk management , medical device, combination products, prefilled syringes, autoinjectors, ... picture, and how activities link to our Company strategy and business goals.Utilize device risk management tools to build device or combination product risk … more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …processes including audits, regulatory intelligence, regulatory inspections, change management , and quality risk management and support strategic ... CSV/CSA and GxP validations, ensuring seamless integration across platforms. Risk Management : Implement and manage a ...Oversee and or participate in internal audit programs and lead IS quality audits to ensure regulatory … more
- Merck & Co. (North Wales, PA)
- …for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management , and other company ... communicate results of clinical trials to the project team, company Management , regulatory agencies, or individual investigators.Provides responses to queries… more
