- BNP Paribas (New York, NY)
- …with the business Conducting impact analysis and communicating to internal stakeholders Regulatory Change Management : Ensuring that new regulations impacting ... any compliance risks, results of controls and industry regulatory matters. Regulatory Inquiries and Examinations Management : This team acts a coordination… more
- On-Board Companies (Westlake, OH)
- …Sheets (SDS) and labels in accordance with HazCom 2012 and WHMIS 2015 Support regulatory projects and change management processes Respond to basic customer ... On-Board Scientific is hiring a Regulatory Affairs Specialist in West Lake, OH For immediate consideration please send your resume to ###@onboardusa.com Subject… 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)
- …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
- Aequor (Thousand Oaks, CA)
- …managing projects, ensuring timely delivery and adherence to budgets. o Skills in change management to effectively implement new processes and technologies. o ... processes Regulatory Compliance and Quality Assurance: Ensure all data management activities comply with regulatory standards (eg, FDA, EMA, ICH-GCP).… more
- Merck & Co. (Durham, NC)
- …License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Adaptability, Biodesign, Capital Projects, Change Control Management , Chemical Engineering, ... Personal Initiative, Process Innovation, Process Optimization, Professional Integrity, Project Management , Regulatory Inspections, Risk Control Assessment, Root… more
- Genmab (NJ)
- …developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines(R) that change lives and the future of cancer treatment and serious ... 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 leading… 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 ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …is responsible for maintaining and advising new projects on the Building Management System while collaborating with the Engineering team to provide necessary ... supervision and conduct testing Core roles include communication, compliance, risk management , and use of current technology System Design and Specification… more
- Merck & Co. (Durham, NC)
- …support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area ... process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author or… more
- Merck & Co. (Durham, NC)
- … regulatory audits/inspections.Good oral and written communication skillsProject management , including change control and equipment qualificationPreferred ... Analysis, PM optimization, RCA, etc.)Strong planning, scheduling, and time management skillsWorking knowledge regulatory requirements in accordance with… 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
- Aequor (Thousand Oaks, CA)
- …timely manner and elevating cross-functional customer concern to various levels of management as appropriate. Owning Change Controls in Trackwise, ensuring ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills.… 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 ... of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our… more
- Merck & Co. (South San Francisco, CA)
- …Biology, Biochemistry. -The ability to influence scientists to adapt to positive change . -Experience with regulatory submissions and understanding of the review ... enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role in developing,… more
- Merck & Co. (Durham, NC)
- …background Required Experience and Skills: Strong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP ... in problem solving and troubleshooting Preferred Experience and Skills: Project management , including change control and equipment qualificationSAP experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …platform changes/improvements in a global manufacturing network and drive change management process from inception through regulatory approval to global site ... and deliver a process platform is robust and consistent. Portfolio management is required to implement process improvements, optimization, capacity expansion, and… more
- Novo Nordisk Inc. (San Francisco, CA)
- …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)
- …Skills, Procurement, Procurement Management , Production Planning, Project Procurement Management , Regulatory Compliance, Risk Management , Stakeholder ... Capital sourcing (Construction, Engineering, Process/Manufacturing Equipment Categories), stakeholder engagement, management and performance improvement of the capital spend, and… more
- Merck & Co. (Durham, NC)
- …Required: -Project Management experienceStrong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP ... Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, support may extend… more
