- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... Japanese, and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and … more
- Merck & Co. (North Wales, PA)
- …and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership to… more
- Merck & Co. (North Wales, PA)
- …Description: Reporting to the AVP of New Modalities our Manufacturing Division Quality , this leader is responsible for supporting the implementation of a unique ... quality oversight model necessary to facilitate agility and speed-to-market...actions, of the new organization to support a fit-for-purpose quality management system and ensure strategic quality … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Policy position is a high exposure and high impact commercial role accountable for executing key policy initiatives ... patient access to our Company's life-saving cancer treatments.The Associate Director , US Oncology Policy will report to the ...motivate others to action, and drive results with pace, quality , and impact. To put it simply, the successful… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... support of their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory… more
- Merck & Co. (North Wales, PA)
- …and capabilities to enable franchises to develop and execute high- quality , compliant omnichannel content and campaigns for priority launchesProvide omnichannel ... roadmaps, strategies, standards, and products, empowering them to inform and execute creative, media, and channel plans that enable a blend of physical and digital channel orchestrationAid in upskilling franchises on omnichannel strategy proficiency through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of a ... external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive ... for formal presentation to senior management.Generates and maintains high quality risk management and communication plans. Independently identifies issues and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Job Summary:The Associate Director of Digital and Omnichannel Analytics Technology is responsible for leading ... accurate and reliable data is captured from various channels. Ensure data quality and accuracy.- Analyze and interpret data to derive actionable insights and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and accuracy of analysis results. Ensures timely delivery of high quality deliverables.- Global Health Authority Interaction / Negotiation: Authors documents and ... responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed.- Global BDO Strategy to Improve Drug Development: Leads global BDO initiatives to improve the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... validation and dissemination- Identify innovative ways to improve the efficiency, quality and productivity of AI/ML activities and actively contribute to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical Study Reports… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role...role such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant therapeutic experience and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submissionManage CRO to ensure high quality compound and multi-compound level deliverablesLead the development of global harmonization ... (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable costIdentify/develop tools for efficient vendor management-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leading all planning activities for Daiichi Sankyo major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions ... research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... stakeholders to optimize Statistics technology, processes, and standards (improving quality /inspection readiness, decreasing cycle times, and reducing costs). Qualifications:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manage project timelines and coordinate appropriate internal resources to create high- quality , on-time deliverables that stay within scoped timeline and budget.- ... Develops project kick-off decks, project status updates, executive summaries and case studies, and document client meetings. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
