- Merck & Co. (Rahway, NJ)
- …business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership and Technical Project Management:Provide ... with a strong understanding of quality management systems and regulatory compliance .Exceptional project management skills and principled verbal… more
- Merck & Co. (North Wales, PA)
- …Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership ... Job DescriptionPrincipal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an...CMC guidelines regarding IND/BLAs or post approval changes.The CMC Project Lead is accountable for the delivery of all… more
- Eisai, Inc (Exton, PA)
- …CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Strom Minnesota (South Saint Paul, MN)
- …and directly the quality assurance program designed to ensure compliance to customer and statutory/ regulatory requirements along with facilitating continuous ... Excellent communication skills and strong team leadership skills Working knowledge of regulatory compliance and business strategies preferred. Lean or Six Sigma… more
- Tris Pharma (Monmouth Junction, NJ)
- …builds in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures ... (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director/Director, AR&D serves as Deputy… more
- Merck & Co. (Rahway, NJ)
- …success in the assurance of deliverable quality and process compliance .Ability to anticipate stakeholder and regulatory requirementsPreferred Experience and ... product lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance , (2) effective deliverable development utilizing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with ... amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service… more
- Merck & Co. (North Wales, PA)
- …data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability to turn ... stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Aequor (Tallahassee, FL)
- …and case quality including analysis and reporting of trends in quality measures Ensure vendor compliance with approved processes and training requirements ... Support reviews of contract wording for case related data exchange Monitoring compliance in regard to regulatory submissions and/or contractual wording for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesDevelops metrics to drive ... preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… 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 ... will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … data are provided to HCPs wherever Novo Nordisk does business Assure compliance with applicable regulatory requirements as they affect Scientific Digital ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (Austin, TX)
- …of capital projects, in a sourcing or procurement lead role or another role on the project team? (3) How many capital projects teams have you worked on over the last ... you have worked on in recent years, what was the dollar value of the largest project ? (5) During the interview with hiring manager, you will be asked to walk through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance : Understand study conduct from supply chain/drug ... collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy: Develop and… more
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