- 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. (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
- Merck & Co. (Rahway, NJ)
- …Responsibilities: Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions. Lead the… 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
- Merck & Co. (Rahway, NJ)
- …Manager to join the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line. The ideal candidate will ... Technology Partners to own, set, and communicate the product vision, strategy , and outcome roadmap, aligned with strategic priorities.Proactively engage stakeholders… more
- Merck & Co. (Rahway, NJ)
- … regulatory compliance while advancing the credit union's payments strategy in alignment with its growth objectives.Key Responsibilities:Develop and execute the ... Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation...organization's payments strategy , aligning with overall business goals and member needs.Monitor… 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
- 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
- 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
- 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
- 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
- Lundbeck (Fort Wayne, IN)
- …transform lives. It's a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, ... you lead the promotion of our infusion product, driving demand...apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory… 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
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the… more
- Lilly (Indianapolis, IN)
- …internal quality systems . + Own relationship and interaction strategy with US and Canada regulatory authorities. + ... world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead ...is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local… more
- Southwest Power Pool (Little Rock, AR)
- …experience and geographic location will all be considered during the hiring process. Lead Regulatory Affairs Engagement Coordinator | Pay Range: $95,200.00 - ... Pay Range: $85,800.00 - $109,450.00 **Join SPP as a Regulatory Affairs Engagement Coordinator - Lead or...will serve as the principal architect of SPP's state regulatory outreach strategy and a key advisor… more
- Koniag Government Services (Washington, DC)
- **Koniag Professional Services,** a Koniag Government Services company, is seeking a Content Strategy Lead to support KPS and our government customer in ... time off, and more. Koniag Professional Services, is seeking an experienced Content Strategy Lead to develop and execute comprehensive content strategies for our… more
