- Eisai, Inc (Nutley, NJ)
- …and recommend appropriate technologies and platforms to accommodate evolving regulatory requirements, user needs and business and functional requirements. Lead ... delivery of HCM based technology solutions. Application Support and Operations Management Manages the development, deployment, monitoring, maintenance, upgrade, and… more
- Eisai, Inc (Nutley, NJ)
- …and recommend appropriate technologies and platforms to accommodate evolving regulatory requirements, user needs and business and functional requirements. Lead ... Chargebacks etc. ) based technology solutions. Application Support and Operations Management Manage the development, deployment, monitoring, maintenance, upgrade,… more
- Merck & Co. (Rahway, NJ)
- … affairs and project management to support our cross-functional projects and streamline our regulatory operations processes. As a key member of our team, you ... and championing process improvements to enhance the quality and speed of our regulatory operations activities. In this role, you will have the opportunity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, ... research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business stakeholders ... development, implementation, and maintenance of software systems that support business operations and objectives, with a special emphasis on HCP engagement systems.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the ... in collaboration with relevant stakeholders including Data Management, Clinical Operations and QCP/CDx/Clinical BiomarkersSupport clinical study teams and functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected to ... setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... with and understanding of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the following: o 21 CRF… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Motion Recruitment Partners (New York, NY)
- Regulatory Operations Manager New York, New York **Hybrid** Contract $66/hr - $71/hr Grow your career as a Regulatory Operations Manager with an ... logistics and advisory. Will have the unique opportunity to contribute to the regulatory environment, manage large programs and engage across all levels of the… more
- Publicis Groupe (New York, NY)
- …trades, or just an all-around nice person, let's chat. **Job Description** The Manager , Regulatory Review is responsible for ensuring regulatory submissions ... to PM and Account teams as they prepare projects for Medical Legal Regulatory (MLR) review + Submit completed materials to the client, both electronically and/or… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Senior Manager , Regulatory Promotional Operations is responsible for managing a ... identifying and solving potential issues across their account(s). Additionally the Senior Manager , Regulatory Promotional Operations must traffic, manage and… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Senior Manager , Regulatory Promotional Operations is responsible for managing a ... identifiying and solving potential issues across their account(s). Additionally the Senior Manager , Regulatory Promotional Operations must traffic, manage… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Senior Manager , Regulatory Promotional Operations , is a subject matter expert ... materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process. Acting as a lead for a...for a brand or portfolio of brands, the Senior Manager oversees a team of Associates, Senior Associates, and… more
- Publicis Groupe (New York, NY)
- …company with the stability and experience of a global leader. **Job Description** The Manager , Regulatory Promotional Operations , is a subject matter expert ... materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process. Acting as a brand lead, the... (MLR) process. Acting as a brand lead, the Manager is responsible for tracking the progress of each… more
- Bayer (Whippany, NJ)
- …**Reference Code:** 829446 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Regulatory Affairs, Compliance, Operations Manager , Law, ... to make a real difference, there's only one choice.** **Assistant Director Regulatory Affairs North America Operations ** The Assistant Director Regulatory… more
