- Novo Nordisk Inc. (Plainsboro, NJ)
- …and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise ... advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …financial milestones and related payment schedules) Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical ... 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
- Genmab (Plainsboro, NJ)
- …effective, and compliant submissions in line with the overall strategy Drive compliance with regulatory guidelines through prompt communication with relevant ... our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Fidelity Investments (Merrimack, NH)
- …Management Team is responsible for establishing and maintaining rules in the core compliance engine to monitor for client, regulatory and internal policy ... economics) preferred5-10+ years experience in financial services industry, with relevant compliance , regulatory or other related functional, operational, or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation ... (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through ... plans and contributes to the development of group strategiesPriorities based on compliance , departmental budget and profit plan to address resource and operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …groups within DSI and global entities, advising on legislative and regulatory compliance , lobbying activities, political contributions, public policy ... media relations, internal communications, public disclosures, social media policies, compliance , crisis communications, and diversity initiatives. Develops contract templates,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …into actionable marketing strategies to guide customer experiences Understanding of regulatory , compliance , and ethical considerations in engaging with ... Area leads, Sales, Patient Support Program, CIA&A, Medical, Legal, and Regulatory and IT. Essential Functions Portal Strategy Development: Leading the development… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Good Documentation Practices (GDocP)Supervise Finishing activities to ensure operational efficiency, regulatory compliance , safety and production goals are met ... compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration....self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to new and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance , Cost of Quality, Validation on Time. Job ... strong and efficient conformance to all quality expectations and compliance with all regulatory standards. This position is the decision maker for the… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of post-law school experience required- 4 or More Years experience in regulatory , compliance , and legal matters relating to investigational products, product ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …dynamics, especially within specified therapy area preferred Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centres of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …into actionable marketing strategies to guide customer experiences Understanding of regulatory , compliance , and ethical considerations in engaging with customers ... and customer groups. The owner is responsible for coordinating with agencies for regulatory review planning, and ensuring best practices in SEO and SEM. The owner… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Technically independent and maintains up-to-date knowledge of relevant standards and regulatory compliance requirements and independently contributes to the ... work, general instructions on new assignments. Knowledge of Automation GMPs, Compliance , and Regulatory requirements is essential Excellent communication skills… more
- Ochsner Health System (Chalmette, LA)
- …competency in section. Performs routine and special lab procedures. Maintains regulatory compliance and performance improvement. Assists and consults with ... in maintaining a section that complies with the standards of accrediting/ regulatory agencies, and maintains confidentiality of patient related information at all… more
- Merck & Co. (South San Francisco, CA)
- …and related documents, managing author/management reviews, ensuring documents meet regulatory compliance requirements, and ensuring documents and document ... in Microsoft Office and GraphPad PrismA good understanding of the content of regulatory filings for nonclinical pharmacology in the context of CTD, IND, IMPD,… more
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