- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct...on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory … more
- Merck & Co. (Rahway, NJ)
- …Affairs and Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist ( Senior Director ) and/or Distinguished ... Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory … more
- Merck & Co. (North Wales, PA)
- …and negotiate with key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic understanding ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Repligen (Waltham, MA)
- …company Lead SOX risk assessments, audits, and remediation efforts Partner with senior leaders to embed strong controls into business processes Mentor and develop ... including risk assessments, documentation, testing, remediation, and reporting.Collaborate with senior management and cross-functional teams (Finance, IT, Legal, Operations)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... and inspection preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for all key health… more
- Eisai, Inc (San Jose, CA)
- …If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology ... within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the oral… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director , the Senior Specialist will work closely with our ... scientists, our Manufacturing Division and Animal Health product experts, global regulatory , controlled substances and others to enable the correct classification of… more
- Merck & Co. (Rahway, NJ)
- …Reporting to the Customs & International Trade (CIT) Valuation Associate Director , the Senior Specialist position's core responsibilities are to ... that the customs value declared is in line with financial payments. The Senior Specialist position's key responsibilities are around these two programs as well as… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionSr. Specialist, Biosafety The Sr . Specialist of Biosafety is accountable for providing and managing an efficient and effective Biosafety program at ... working environment in compliance with local, state, and federal regulations. The Sr . Specalist of Biosafety will collaborate with various departments to promote… more
- Merck & Co. (North Wales, PA)
- …monitoring, analysis, regulatory reporting, and publication. --Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... create breakthrough science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. SummaryThe Sr . Director , Data Quality and Integrity (Global R&D & PV QA) ensures ... and determining audit targets for GxP systems.ResponsibilitiesLeadership and Strategic DirectionThe Sr . Director , Data Quality and Integrity is essential in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights ... and rotations.Demonstrate analytics' value in solving complex business challenges.Engage senior leaders to drive strategic analytics transformations.Partner with Data… 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 ... pharmacodynamic endpoints/platforms, and early phase vaccine trials.Reporting to the Executive Director and Head of TMS (in EDS/BARDS), the incumbent will manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on ... Executive Director of Strategic Operations. This position interacts with senior leadership (Executive and Leadership Teams) and collaborates closely with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …global ethics and compliance program. Relationships Reports to the Executive Director , Risk Insights & Management. Manages a team of compliance professionals ... and maintain dashboards and reports to provide actionable insights to senior leadership Oversee the implementation of technology solutions for compliance monitoring… more
- Taiho Oncology (Bear, DE)
- …Co., Ltd., a renowned Japanese leader with over 2,700 employees worldwide. As Sr ./ Director People Business Partner Europe, you will step into a dynamic ... Director , People Business Partner Europe Baar, Switzerland Req...initiatives with global policies while adapting them to local regulatory and cultural needs. Client Partnership & Coaching Build… more
