- Exela Pharma Sciences, LLC (Lenoir, NC)
- …areasChange Management - Assure that the engineering department adheres to regulatory , and company change management requirements. Possess strong ... delivery. The Quality Engineer will assure that cGMPs and regulatory standards are applied in a consistent manner by...Change Management knowledge. Asset Management - Provide support to maintenance department and assure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …labeling milestone tracking system along with associated processes for content and change control management . Explore opportunities to leverage emerging digital ... veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, project management , change and risk management . Responsibilities - ... veterans and people with disabilities. Summary The Associate Director, External Data Management , is accountable for the end-to-end delivery of External data in… more
- Merck & Co. (North Wales, PA)
- Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our company. Position Description/Summary The Senior ... development efforts. The Senior Specialist is expected to provide project management leadership and drive cross-functional teams with sufficient influence and… more
- Aequor (Thousand Oaks, CA)
- …role will own the execution of the implementation plan in terms of project management and change control execution. This role will apply project management ... areas Assure timely and fully compliant (RFT) maintenance of Change Control Management system related to Global... Records (CFSCR) Provide timely updates to stakeholders, eg, Regulatory , Supply Chain, Manufacturing, Quality on status of GDCR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and inspections. Finally, this position has strong skills in continuous improvement, project management , change management , and risk management . ... immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technology or techniques in the context of clinical development required- Proven change management experience required- Proven strategic and innovative thinking ... encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory , biostats, data management , and other key stakeholder… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in accordance with business guidance and ethics Identifying opportunities for change management that enhance efficiencies across the contracting life ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...identifying areas of improvement and optimization including ideas for change management Demonstrated ability to work independently… more
- Merck & Co. (Rahway, NJ)
- …and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills including budget forecasting ... frameworks such OSHA , OHSAS 18000, EPA, ISO, NFPA,GMPStrong leadership, talent management , change execution, and financial management skills.Readily and… more
- Merck & Co. (Rahway, NJ)
- …changes and developments align with business requirements, industry standards, and regulatory compliance.Adhere to change control processes and methodologies to ... candidate will provide functional design and guidance for the Finance Business Management (FBM) processes and manage end-to-end SAP technical configuration for the… more
- Novo Nordisk Inc. (Boulder, CO)
- …ability to work independently and with cross-functional teams, including Materials Management , CMC, Regulatory , Quality, teams Strong organizational, planning, ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Aequor (New Brunswick, NJ)
- …regarding stability program that may impact lab capacity, product studies or regulatory commitments directly, escalate promptly to management and act as ... degree required Must Haves: 8&plus years of experience in Stability Program Management for small molecules (oral and sterile product) Strong understanding of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of deviations, events and key process parameters and provides reports to management on trending, and status as requested. Identify and implement process improvements ... compliance, productivity, yield, and cost. Implement process improvements within the change control system. Recognize and act on potential compliance issues and… more
- Catalent (San Diego, CA)
- …Environmental Monitoring, Site Label Control, including review, release and approval process. Site Change Control/ change management programs. Site Risk ... Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary responsibilities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …, team collaboration, training and development, employee engagement, and recognition Change management : Identifying areas for improvement in operational ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...in designing and implementing innovation/improvement initiatives, including the required change management Project Management experience… more
- Merck & Co. (Durham, NC)
- …or regulatory audits/inspections.Good oral and written communication skillsProject management , including change control and equipment qualification Preferred ... Analysis, PM optimization, RCA, etc.)Strong planning, scheduling, and time management skillsWorking knowledge regulatory requirements in accordance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …effectively influencing in a matrixed, global environment. Experience in successful change management including developing the strategy and implementing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...The Position Partner with NACD functions to support capacity management based on current capacity, headcount/budget constraints and demand.… more
- Novo Nordisk Inc. (Pittsburgh, PA)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …instrumentation, and computerized systems.Knowledge of quality systems including exception management , change control, document control.Knowledge of operating ... documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and CDR rules,… more
