- Merck & Co. (Rahway, NJ)
- …the companyEducation:Bachelor's degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management ... Job DescriptionThe GRACS Global Process Lead (GPL) is responsible for overseeing and managing...minimum of 8 years of industry experience including a regulatory and/or compliance area and experience with… more
- Merck & Co. (Rahway, NJ)
- …final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory ... to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on… more
- Merck & Co. (Rahway, NJ)
- …for someone with a growth mindset.Position Description: The Senior Director, Global Regulatory Lead , is responsible for development and implementation of ... final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory … more
- Merck & Co. (Rahway, NJ)
- …another's thinking and approach problems collectively. As an ERP Direct Procurement Lead , you will: Design and shape our Company's Direct Procurement solution ... collaborate with other SAP and non-SAP Business Areas, Digital Manufacturing Division, Compliance , our Research & Development Division Value Team, GSMG etc. Hold… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...a DEV/OPS SAP technology team, responsible for development/ governance/ operations of the enterprise-wide technical SAP ERP asset. Their… 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 ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… 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 interact… more
- Merck & Co. (Rahway, NJ)
- …in cluding Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations , and CMC Regulatory Affairs , to address technical ... a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations .- In this role, the selected candidate will be responsible for residual… more
- Merck & Co. (Rahway, NJ)
- … regulations.Desire and willingness to learn, contribute and lead through independent problem-solving.Effective interpersonal and communication skills, both ... experience Preferred Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety, environmental, compliance /qualityUnderstanding of… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating… more
- Merck & Co. (Rahway, NJ)
- …Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering ... Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... experiment with us? The Position The purpose of the Integrated Customer Engagement Lead is to develop and implement a comprehensive engagement strategy that aligns… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards; ... Maintains strong understanding of omnichannel best practices, digital spaces, Marketing and Regulatory /Legal aspects to ensure compliance with legal, quality and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Operations to advise on commercial strategies. Furthermore, the Lead is responsible for advancing channel standardization and innovation, developing channel ... within Omnichannel Engagement, including the Therapeutic Area Orchestration Strategies and Experience Operations Teams. The Lead will also interface with teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Content Management & Production Lead reports directly to the Experience Operations Lead as part of the Customer Experience & Marketing Enablement ... and approval workflows within the DAM system to maintain content integrity and compliance with regulatory requirements. Stay informed about emerging trends and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- ... record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of CX Architecture & Automation Lead reports directly to the Experience Operations Lead as part of the Customer Experience & Marketing Enablement ... information to the organization Measurement, Optimization, & Innovation: Support the Experience Operations Lead to establish KPIs, SLAs and quality standards for… more
