- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMACompetencies:Advanced knowledge of ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Merck & Co. (Rahway, NJ)
- …audits to investigate frequent field alerts, recalls, rejects and complaints.Support in informing Senior Management of emerging regulatory and PV trends to help ... aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job… more
- Merck & Co. (Rahway, NJ)
- …the preparation of materials for program presentations for management review and regulatory submission.Contribute to the development, implementation, ... Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will ... Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory … more
- Merck & Co. (Rahway, NJ)
- …improving and protecting patient access to care. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the Executive Director, ... the Company's vaccines pipeline, including during late-stage development, distribution and regulatory milestones, in a manner that reflects the Company's purpose and… more
- System One (Florham Park, NJ)
- Senior Regulatory Operations Associate Contractor (Publishing) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) ... Senior Regulatory Operations Associate Contractor...managing the lifecycle of submission-related documents. + Conduct final review of published submissions to ensure consistency and compliance… more
- Publicis Groupe (New York, NY)
- …company with the stability and experience of a global leader. **Overview** The Senior Associate , Regulatory Promotional Operations must follow the protocol ... by our pharmaceutical company clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
- Publicis Groupe (New York, NY)
- …(or group of clients) follow the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a key role in ... & RESPONSIBILITIES:** + Manage multiple direct reports at the Associate , Senior Associate , and Manager...estimates for SOW development + Work with the Director, Regulatory Review in the development of departmental… more
- Publicis Groupe (New York, NY)
- …and annotating pertinent information. + Manage multiple direct reports at the Associate , Senior Associate , and Manager levels, including responsibilities ... stability and experience of a global leader. **Overview** The Senior Manager, Regulatory Promotional Operations, is a... Associates, and Managers to ensure a seamless MLR review process from start to finish. The Senior… more
- JPMorgan Chase (New York, NY)
- …and other Corporate Functions to obtain information/documentation to respond to regulatory requests. + Review , analyze, and summarize information/documentation ... regulatory requests. Provide feedback and strategic advice regarding responses to regulatory requests. + Prepare personnel (and senior management) for… more
- JPMorgan Chase (Brooklyn, NY)
- …capital stress testing, including internal and regulatory requirements. As a Regulatory Capital Reporting & Analysis - Sr. Associate within the Firmwide ... , FR Y-9C & Call report + Consolidate and review variance analysis + Support the intra-quarter RWA control...work and help create the various presentations decks to Senior Management, internal audit and Regulatory Agencies… more
- Mizuho Corporate Bank (New York, NY)
- …Quality Assurance Unit is responsible for enhancing the integrity of the bank regulatory reporting processes, reporting data quality as well as the overall control ... and on-going assessments of the accuracy, completeness and timeliness of financial regulatory reports submitted to the US bank regulators. The Unit also partners… more
- CUNY (New York, NY)
- Senior Associate Dean for Academic Affairs **POSITION DETAILS** The CUNY School of Medicine (CUNY SoM) located in the heart of Harlem, New York, is the only ... student body. The Dean's Office is currently seeking a Senior Associate Dean for Academic Affairs. Reporting...directors; including tracking and coordination of administering survey and review and discussion with the chair or deans and… more
- Principal Financial Group (New York, NY)
- **What You'll Do** We're looking for a Senior Associate to join our Fund Administration, Tax & Oversight team. In this role, you'll be responsible for ... team in achieving operational readiness. + Financial Statement Preparation and Regulatory Requirements - Prepare/ review financial statements (including balance… more
- Deloitte (New York, NY)
- …institution compliance officers, and more. As an Anti-Money Laundering ("AML") Project Associate ( Senior Consultant), you will have the opportunity to help ... please consider an opportunity with Deloitte as a Project Associate . A Project Associate at Deloitte plays...as well as to improve their ability to meet regulatory requirements, expectations , and guidance in support of… more
- Santander US (New York, NY)
- AVP, Senior Payment Risk Associate New York, United States of America The AVP, Senior Payment Risk Associate will be responsible for identifying, ... managing operational risks associated with payment operations, ensuring compliance with regulatory requirements, and contributing to the development of robust risk… more
- Cover Whale (New York, NY)
- …2023 (forbes.com) (https://www.forbes.com/lists/americas-best-startup-employers/?sh=39bb36d22ad7) . The Role As a Senior Compliance Associate , you will play a ... with applicable regulations + Assist with overseeing adherence to and review of corporate-level policies, internal procedures, and regulatory compliance… more
- Pfizer (New York, NY)
- …plans, including data preparation and validation activities, among others. As a Senior Associate , your knowledge and skills will contribute towards the ... required for the reporting of clinical trial data (eg data review , study reports, regulatory submissions, safety updates, etc.) + Knowledge of regulatory … more