- Novo Nordisk Inc. (Plainsboro, NJ)
- …requirements and commercialization goals in collaboration with R&D Pipeline Optimization and Risk Management : Advise annual planning for early products and ... as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic...for pipeline assets. Lead early product component of lifecycle management strategy utilizing "one impact planning". Proactively… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR...side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project management , change management , and risk management . Responsibilities Leadership, Direction, and Strategy :Establishes Data Management ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the respective PV inspections in alignment with regulatory and company strategy .Act as the management representative for all key health authority inspections ... impacting products from a quality perspective. Provide updates to management on MTP strategy for PV QA...the GvP modules in support of a proactive quality risk management process.Interact with the audit and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in how we engage customers. Leverage analytics and market research to inform strategy and opportunities for growth. Business Operations Management : Develop and ... thinking and analytical skills, with the ability to translate insights into strategy Excellent communication and stakeholder management skills, with ability to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Director, the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with business guidance and ethics Identifying opportunities for change management that enhance efficiencies across the contracting life cycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and Strategy :Provides data ... project team regarding the data management DM activities and deliverablesEstablishes Data Management strategy at the project and/or study level for a larger… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Position ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will require proven skills in continuous improvement, project management , change management , and risk management . The position will act as main ... the development of study protocol (design, sample size, statistical analysis strategy ); Review CRF; Write SAP; Manage statistical analysis outputs with programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug… more
- Merck & Co. (North Wales, PA)
- …Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in ... guidelines, regulatory precedence and competitive Intelligence to facilitate development of regulatory strategy . Assists the global liaison in authoring of … more
- Merck & Co. (North Wales, PA)
- …with internal and external stakeholders at all levels, including senior management and vendor partnersPossesses a strong understanding of relevant regulatory ... to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges associated with digital technologiesExperience in navigating … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Contracting & Distribution Strategy (C&DS) Field Execution role plays a critical leadership role in the development of contracting confidence and- ... teams, field sales leadership, Vaccines Portfolio Marmeting Team, Integrated Account Management , Learning and Development, Clinical Review Teams, Legal and… more
- Merck & Co. (North Wales, PA)
- …collected from Clinical Trials are used to support drug applications and regulatory submissions to health authorities globally.Trial Data Management (TDM) is ... Trials domain to help us implement our vision and strategy to enable the software products within the Trial...to enable the software products within the Trial Data Management area to power the business for the next… more
- Merck & Co. (North Wales, PA)
- …with internal and external stakeholders including Statistics, Clinical Research, Regulatory , Observational Research, Clinical Safety and PK/PD Modeling and ... oral, and presentation skillsSuperior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for Research &… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
