- Merck & Co. (Rahway, NJ)
- …CMC regulatory strategy, risk, mitigation, and overall plan to the Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development ... change support.-Minimum of (7) years of significant People Management / Leadership experience with proven track record of developing talent.-Recognized… 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
- Merck & Co. (North Wales, PA)
- …RIM-based global content source management solution and function as BSOLead the Change Management and Business Process activities to drive adoption of the ... of improvement initiatives including business process design, coordination of IT activities, change management and trainingPartner with QA and Standards to… more
- Merck & Co. (North Wales, PA)
- …healthcare, or life sciences.#eligibleforERPRequired Skills: Adaptability, Adaptability, Change Management , Communication, Computer Science, Critical ... Process, Metadata Management , Policy Implementation, Process Improvement Projects, Project Management , Regulatory Affairs Compliance, Regulatory Affairs … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …where your distinct perspectives and expertise are valued as we work together to change lives for the better. The Position The Director, Media Relations & Issues ... Management is accountable for establishing and leading Novo Nordisk's...Affairs, Legal, Finance and Investor Relations, Clinical, Medical and Regulatory , plus other cross functional teams as needed. Key… more
- BioAgilytix (Durham, NC)
- …technical concepts clearly and work cross-functionally to align data management goals with BioAgilytix's operational and regulatory requirementsDemonstrated ... checks, and setting up clear governance so everyone knows who can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and inspections. Finally, this position has advanced skills in continuous improvement, project management , change management , and risk management . ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance- Ensures that Data Management Plans are consistent and… more
- Merck & Co. (Rahway, NJ)
- …planning, integrated risk management , cost of goods projections, post approval change management and lifecycle strategies for their product(s).- As a result, ... , Strategic Thinking, Supply Chain Analytics, Supply Chain Metrics, Supply Change Management , Vendor SelectionPreferred Skills: Current Employees apply HERE… 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)
- …process validation, second generation process development and authoring of regulatory submissions.-We are seeking a strategic and technical leader with ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Revel IT (Worthington, OH)
- …an ongoing basis. Helps develop, coordinate, or facilitate technology communication and change management plans and processes to communicate updates, maintenance ... times a MONTH (the rest is remote) Essential Activities and Tasks Operations Management Supports the use of all client electronic medical records and other clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …status, escalating issues in a timely manner for earliest resolution, Regulatory Inspections:Facilitates regulatory inspection preparation, management , and ... Medical Affairs teams and related submissions, supporting the preparation and management of regulatory inspections in collaboration with business functions.… more
- Aequor (Thousand Oaks, CA)
- …years exp. Familiar with pharmaceutical sciences, quality, compliance and regulatory requirements, associated with biologics and synthetic chemical manufacturing and ... areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory , Quality Engineering, International Quality and Process development on… more
- Merck & Co. (Rahway, NJ)
- …processes, drive continuous improvement, and optimize workflows for efficiency gains Change Management and Problem-Solving: -Capability to challenge current ... suppliers with PO and invoicing issues, manage expedited payment requirements per regulatory requirements Contractor Invoice Management : Process purchase orders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for business process workstreams. Support the efforts of Process Owners to drive change management and implementation of major process design changes. Support ... technology or techniques in the context of clinical development preferredProven change management experience preferredProven strategic and innovative thinking… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...process improvements related to patient safety. Also support case management activities within US Patient Safety Team. Relationship Reports… more
- Merck & Co. (Millsboro, DE)
- …industry technical business processes:- change control, deviation management , technical protocols/reports, and regulatory license documents.-Current ... and other stakeholders to ensure effective communication for scoping, planning and change management .Stay abreast of scientific developments and trends in… more
- Merck & Co. (Rahway, NJ)
- …and represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence Serve as ... coach to the HF team and key stakeholders across R&D, clinical, regulatory , marketing, manufacturing, and quality functions.Educate and build awareness of HF… more
- Insmed Incorporated (NJ)
- … change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations, and Program Management to drive ... management experience.Proven expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical… more
