- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and...matter expert (SME) and act as company's representative during regulatory agency inspections and vendor audits.Ensure that a risk-based… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will ... supply.Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … senior managers within Daiichi Sankyo on scientific and regulatory issues.People Management: Mentors/instructs and provides guidance to internal and external ... the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies adhere to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director ( Sr . Principal Scientist) has primary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to ... DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in...indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and… more
- Creative Financial Staffing (Columbus, OH)
- …Sr . Accounting ManagerHybrid schedule in downtown ColumbusPosition Summary:The Senior Accounting Manager will lead all day-to-day finance operations and ... training & development as needed. Through program administration and coordination, the Senior Accounting Manager will ensure that the organization has the financial… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and ... and scientific communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Merck & Co. (Rahway, NJ)
- …in driving operational excellence. This role reports to Executive Director , SAP Platform TeamResponsibilities: Leadership and Strategy:Develop and execute the ... and developments align with business requirements, industry standards, and regulatory compliance.Define and enforce change control processes and methodologies to… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent ... additional suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, develops, and ... and design history file development.Remain current in relevant worldwide regulatory guidance and standards.Proactively resolve project obstacles and challenges and… more
- Merck & Co. (Washington, DC)
- … will monitor, analyze, and communicate internally about federal legislative and regulatory activities and initiatives.- The Associate Director will also ... Job DescriptionPosition Description: Associate Director , Federal Policy and Government Relations The Associate Director is responsible for helping to craft and… more
- Merck & Co. (Rahway, NJ)
- …cancer patients globally.We are currently seeking an Oncology Competitive Intelligence Director specializing in Women's Cancers. This role is responsible for ... comprehensive understanding of relevant healthcare environment matters, including policy, regulatory , and health technology.Developing a global internal network of… more
- Merck & Co. (Rahway, NJ)
- …technology transfer to commercial manufacturing sites and authoring of regulatory filing submissions.Nature and Scope of Position:The role serves as ... managing budgets to align actions with strategy.Supervises 5 Directors or Senior Directors, and through them, approximately 85 scientists, people managers, chemical… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and our Company's Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Merck & Co. (North Wales, PA)
- …& Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with ... Essential Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management, and functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
