- Daiichi Sankyo, Inc. (Bernards, NJ)
- … while ensuring alignment with the Global Digital Transformation (DX) strategy , regulatory compliance framework, and overall quality assurance standards. ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Upper Gwynedd, PA)
- …measures.- Lead development and execution of global product and project regulatory strategy (ies) by ensuring robust assessment of global regulatory ... the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory leadership… more
- Merck & Co. (Rahway, NJ)
- …therapeutic area and team leading to global innovative and accelerated regulatory strategy and marketing authorizations for Cardiovascular, Diabetes, ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy .Providing quality advice to… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Insmed Incorporated (San Diego, CA)
- …managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related ... role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national… more
- Twist BioScience (South San Francisco, CA)
- …optimize complex biological manufacturing processes, and align with our overall manufacturing strategy and business objectives. The Director will lead a team ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Merck & Co. (Rahway, NJ)
- …(PC), process performance qualification (PPQ), risk assessment (RA), control strategy , process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA ... guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Aequor (Thousand Oaks, CA)
- …change the world. In this pivotal role, you will report to the Planning Lead within the Global Supply Chain Organization and will be accountable to deliver strong ... and regional planners to ensure 's manufacturing network supply plans.Responsibilities: Strategy Primary focus is to provide thought leadership in orchestrating the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is tasked ... with providing strategy and vision on the technical implementation, optimization, and...Ethics and Compliance, Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. Externally, this… more
- Eisai, Inc (Nutley, NJ)
- …clinical trial design, statistics, etc.) to supplement MSL development.Collaborate with Digital Strategy & Innovation lead on global MSL insights sharing forums. ... activities as well as congress activities. The position serves as a functional lead on cross functional launch planning and other strategic initiatives for Oncology… more
- Eisai, Inc (Nutley, NJ)
- …hear from you. The Regional Thought Leader Liaison (RTLL), Alzheimer's Disease will lead and execute regional and local engagement with existing and emerging Key ... engagement with regional/local advocacy and professional societiesInsights to Inform Brand Strategy Synthesize learnings, translate them into key insights and best… more
- Eisai, Inc (Nutley, NJ)
- …close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study timelines. Gathers ... line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop recruitment strategy… more
- Eisai, Inc (Exton, PA)
- …SOPs, along with providing supporting documentation. They formulate the overall strategy for Upstream and Downstream Operations and will collaborate effectively with ... groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics… more
- Barry-Wehmiller Companies (Los Angeles, CA)
- …the power of business to build a better world. Job Description: Client Development Lead , Validation and Regulatory Compliance (Design Group) Who You'll Work With ... helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from...When you join Design Group as a Client Development Lead , Validation and Regulatory Compliance, you are… more
- Gentle Dental (Wilsonville, OR)
- …oversees the implementation of clinical best practices, ensures compliance with regulatory standards, fosters provider engagement, and partners with operations and ... of the dental clinical environment. Key Responsibilities: Clinical Leadership & Strategy Provide strategic oversight and direction to clinical teams across all… more
- Axalta Coating Systems (Philadelphia, PA)
- …review and optimize .NET code, architect databases, and strategically integrate enterprise systems is required. Additionally, this role will lead internal ... This is a senior-level role, requiring expertise in enterprise technology strategy , software development leadership, and system integration, with a high impact… more
- Radiant (El Segundo, CA)
- …or disaster-relief scenarios. Engineer - Regulatory Radiant is seeking a driven Regulatory Systems Engineer who loves to think outside the box and challenge ... both technical work and operational execution. You will have direct ownership of modernize regulatory strategy to bring the safest microreactor to market in the… more
- DTCC (Jersey City, NJ)
- …Director, you will lead the development and implementation of the finance systems vision and strategy for the Finance organization. In this role, you ... in this role: As the Financial Systems Business Lead , Executive...leading to the development and implementation of a Finance-wide systems vision and data strategy . This role… more
