- Aequor (Newbury Park, CA)
- …relevant issues to GRT Develop Regulatory Position with GRT Actively support regulatory compliance Support the development and execution of GRT goals ... The ideal candidate for this role is an entry-level professional with strong communication skills, adept at understanding and...of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of the pharmaceutical industry including marketing, medical, access, public affairs, compliance , legal and regulatory as well as the healthcare ... and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch Office,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …material. Ensure quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and learn' ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within specified therapy… more
- Novo Nordisk Inc. (Durham, NC)
- …and processes for our operations areas to meet business and regulatory requirements in bulk processing. Additional responsibilities includes but not limited ... deviation investigations, quick containments and root cause analysis Ensure compliance with standards Identify process needs and improvement opportunities for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Eisai, Inc (Nutley, NJ)
- …assesses and provides objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that ... compliance initiatives (strategic and execution).Assess and guide on compliance with regulatory , organizational, and commercial requirements.Define and… more
- Merck & Co. (Rahway, NJ)
- …approaches within Device Development and with external suppliersUnderstand and apply regulatory / compliance requirements relative to design controls and ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. This position will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process changes/improvement.Partner with all stakeholders to implement process improvements.Assure regulatory compliance and technical feasibility of proposed ... recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …they may partner with the Local and Global Clinical Operations, regulatory affairs, medical affairs, legal, communications, compliance , etc. Externally, ... diversity of trial populations, inform strategies for improvement, and ensure compliance with regulatory requirements Physical Requirements 10-20% overnight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards; ... Best Practices: Maintains strong understanding of omnichannel best practices, Marketing and Regulatory /Legal aspects to ensure compliance with legal, quality and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Will utilize prior academic experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding ... support staff. Foster an environment of innovation, collaboration and professional growth. Develop staffing plans and work with the... Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include… more
- Novo Nordisk Inc. (Boulder, CO)
- …associated with aseptic processing Experience working to standards required for regulatory compliance of Aseptic Processing facilities Understanding of ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Merck & Co. (Rahway, NJ)
- …of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document ... for preparing clinical study registration and results disclosure postings in compliance with company policy and country laws and requirements. The disclosure… more
- Merck & Co. (Rahway, NJ)
- …packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Build deep fundamental knowledge around the drug ... product to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership on program development teams,… more
- Merck & Co. (Durham, NC)
- …Responsible for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.- ... Job DescriptionSenior Specialist, Quality Systems and Compliance (P3) Our company is expanding its global...as a member of a team. Manages individual contributors ( professional employees), as applicable. Contributes to the performance and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance, Finance, R&D, Project Management and Quality Control ... cross functional team staff in areas such as quality, compliance , safety, project planning, process development, technology development.Communicate effectively with… more
- Novo Nordisk Inc. (Milwaukee, WI)
- …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...as well as Managed Care and Government by using academic/ professional credentials and scientific expertise to communicate with health… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensures that material is fully released prior to shipment to siteEnsures compliance with all domestic and foreign regulatory requirements but may seek ... and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items...may compromise patient dosing or safety. Basic understanding of professional working environment as well as Quality Assurance and… more
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