- Merck & Co. (Rahway, NJ)
- …Driving License:Hazardous Material(s):Required Skills:Adaptability, Business Systems, Change Management , Communication, Cross-Cultural Awareness, ... Job DescriptionAssociate Director , Business System Labeling Management Required...Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area… more
- Merck & Co. (Rahway, NJ)
- …and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … change agent to promote flexibility, creativity, and accountability.Project management skills, responsiveness to issues, and demonstrated passion for creating ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …assessments and provide expert consultation on chemical manufacturing matters.Review process change requests and deviation reports while ensuring regulatory ... Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines(R) that change lives and the future of cancer treatment and serious… more
- Merck & Co. (Rahway, NJ)
- …License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Business, Business Risks, Change Management , Clinical Development, Clinical ... Management , Process Optimization, Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management Develop and ... ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the...adequate access for consumers at the system level Budget Management Support Assist with the effective management … more
- Twist BioScience (South San Francisco, CA)
- …for both internal development and external services, and demonstrating ROI for MES investments. Change Management : Lead change management efforts related ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Repligen (Waltham, MA)
- …and release including deviation support, root cause analysis, customer complaint management , hosting customer/ regulatory audits and Certificate of Quality ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls, and other product life cycle management… more
- Merck & Co. (Rahway, NJ)
- …development through process tech transfer, scale-up activities, quality investigations, change management , and authoring GMP standard operating procedures ... processing, equipment, and sterile technique.Experience in leading quality investigations and change management .Familiarity with United States and European Union… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are...the right on a temporary or indefinite basis to change or adjust job requirements to meet business, scheduling… more
- Eisai, Inc (Exton, PA)
- …Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge ... suite change -over ensuring compliance to relevant regulations. The Associate Director is also responsible to ensure successful scale-up and technology transfer… more
- Merck & Co. (Durham, NC)
- …and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also ... goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and ... research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Scientists as needed for exploration, experimentation, or new development Project & Change Management Experienced in managing multiple teams and workstreams with ... fast-paced environments with a focus on quality and documentation Skilled in change management and guiding teams through transitions Communication &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams through transitions.Excellent communication and ... but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights… more
- USAA (Phoenix, AZ)
- …of what truly makes us special and impactful. The Opportunity As a dedicated Director , Underwriting Research , you will be responsible for Managing a team of staff ... processes and programs while balancing operational efficiency, competitiveness, and regulatory compliance. Implementation may include overseeing business configuration efforts,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reporting requirements and operational assessments. Relationships Reports to the Director , Patient Support Transformation and Enablement. Works closely with Market ... Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and communication channels related to the NovoCare® Patient Support Programs. Management of relevant data sets include compliance and database information integrity, ... operational execution. Relationships This position reports to the Sr Director , Patient and Consumer Insights. Other key relationships include interactions… more
