- 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development,… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… 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
- 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
- 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
- Fidelity TalentSource LLC (Boston, MA)
- …the vibrant Fidelity Capital Markets trading floor? \u00A0We are looking for a Director of Regulatory Reporting, a leadership position within the team that ... Services, as well as for correspondent client broker-dealer firms. \u00A0\u00A0The Director is responsible for understanding the core businesses of the trading… more
- Aequor (Newbury Park, CA)
- …Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions. ... Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training materials and… 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
- Septa (Philadelphia, PA)
- …reliable source of transportation. We are seeking candidates for the position of Director Safety Regulatory Compliance (7382) in the System Safety. Opening Date: ... Min: $104,000.00 - Mid: $130,000.00 - Max: $156,000.00 OVERALL DESCRIPTION The Director of Safety Regulatory Compliance is responsible for planning, managing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior … more
- Creative Financial Staffing (San Francisco, CA)
- Client Accounting Services, Senior Director Overview:We are seeking an experienced and detail-oriented individual to provide financial management and strategic ... leadership to our not-for-profit clients. As Senior Director , you will work with multiple...accuracy and integrity of financial reporting and compliance with regulatory requirements.* Collaborate with client leadership to develop financial… more
- Septa (Philadelphia, PA)
- …reliable source of transportation. We are seeking candidates for the position of Senior Director Of Maintenance (7279) - VOH in the REE&M/Administration ... with all pertinent ADA regulations and rules and stay abreast of all regulatory and rule changes. Monitors daily activities and the performance of various overhaul… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …to:Planning, preparing and reviewing pharmacometrics-related drug development plans and regulatory filings. This includes determining scope, design planning and ... analyses. Responsibilities include describing results of these studies in various regulatory documents (IND, NDA, BLA, IB, etc.)Apply model-informed drug development… more
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Fidelity TalentSource LLC (Greenville, DE)
- …RoleDue to growth in our business, Fidelity Personal Trust Company seeks a Senior Trust Officer!This role is an integral member of the Personal Trust Administration ... With the help of a dedicated Trust Administrator, the Senior Trust Officer is responsible for all facets of...is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent).… more
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