- Merck & Co. (Rahway, NJ)
- …archive function in strategic planning meetings, system integration workshops, and change management initiatives. Advocate for continuous improvement in archival ... onsite 3 days per week required) - Functional Area: Regulatory Innovation and Information Management (RIIM) within... management and related activities.- Proven leadership in Change Management with an ability to lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal ... risks, and decisions to the team. With direction from management , manages multiple regulatory submission projects, including...it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity… more
- Insmed Incorporated (NJ)
- …by Technical Operations or from CMOs to support development program and life cycle management , and ensure they meet current regulatory standards, are of high ... successful development of CMC submission packages to support product life cycle management .Work effectively with regulatory colleagues and continuously improve … 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
- Merck & Co. (Rahway, NJ)
- …Skills: Adaptability, Adaptability, Business Processes, Business Process Improvements, Change Management , Clinical Research, Cross-Functional Team Leadership, ... , Project Management Information Systems (PMIS), Project Planning, Publications Management , Regulatory Compliance, Risk Management , Sourcing and… more
- Merck & Co. (Rahway, NJ)
- …or managing LIMS (ideally LabWare)Demonstrated success leading development and change management initiatives in a GMP/GLP qualified environment.Strong ... Description - You will be the product owner for a number of Laboratory Information Management Systems used across our Company. The role offers the chance to work on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assures the quality of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous ... to ensure benefit-risk integration to ensure signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management … more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will manage ... cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk … more
- Merck & Co. (Durham, NC)
- …Influence, Leadership, Networking and Partnerships, Program Management , Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance, Risk ... this role, you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance, and enabling manufacturing excellence from development… more
- Aequor (Framingham, MA)
- Shift: 1st Work Schedule: Mon-Fri 800-430The Third Party Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring excellence ... in quality standards and regulatory compliance across external partnerships. This role requires leading Supplier Change Notification (SCN) processes, managing… more
- Merck & Co. (Rahway, NJ)
- …knowledge in QbDRequired Skills: Applied Engineering, Applied Engineering, Capital Management , Change Management , Chemical Process Development, ... Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle, Product Management , Regulatory Requirements, Results-Oriented, Social Collaboration, Stakeholder… more
- Novo Nordisk Inc. (San Antonio, TX)
- …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
- Merck & Co. (Rahway, NJ)
- …and influence across the enterprisePreferred Experience and Skills: Project management , including change control and equipment qualificationSAP experience ... GMP Compliance, HVAC Systems, Key Performance Indicators (KPI), Maintenance Management , Maintenance Processes, Managing Change Requests, People Leadership,… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management , Regulatory Submissions, Risk Management , ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Durham, NC)
- …Maintenance, Automation, and Quality approvers.- As part of the deviation management role, present and defend investigations during regulatory inspections, ... and Skills: Proficient in PI Processbook, Siemens BAS, and DeltaV Project management , including change control and equipment qualification SAP experience related… more
- Merck & Co. (North Wales, PA)
- …(eg, risk stratification tool for personalized patient support) along with associated change management related to how information, messaging, and/or resources ... Campaign Development, Advertising Campaign Development, Brand Management , Business Management , Change Management , Client Facing, Collaborative… more
- Genmab (NJ)
- …a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control ... regulations/guidance's Creates any needed documentation and training for standard processes, change control management and tools Responsible for defining… more
- Merck & Co. (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience supporting/writing regulatory filings… more
- Insmed Incorporated (NJ)
- …of the application, supporting internal and external audits to ensure regulatory complianceManage technical ownership, change control, and documentation while ... Role:This role serves as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated applications,… more
