- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy ... to be a part of our Global Regulatory Affairs organization.In this role, you will work in...of the Company Core Data Sheep and US Prescribing Information . Responsible for maintenance of the IND. Monitor and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... Core Data Sheet, USPI, EU SmPC and related patient information ) for the Genmab portfolio of products. This role...portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that ... Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with colleagues within Patient Support Programs, Patient… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… more
- Genmab (Plainsboro, NJ)
- …in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development ... leading clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Corporate Accounting guidelines in accordance with IFRS regulations. Relationships Reports to the Associate Director of Accounting at Novo Nordisk Inc. As part ... year-end financials (balance sheet, income statement reviews and supplementary information ) to the SVP of Finance & Operations and...Provide monthly status reports on closing process to the Associate Director of Accounting, the Senior … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This person leads the timely and ... agencies inquiries and other reporting requirements are met. Provides information to other internal departments where deemed appropriate.Develop project plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,...E- Work with the business users to define user information needs, research innovative product value proposition, and collect… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... conventions. Reviews and submits DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure accuracy and consistency of… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …will contribute:** + Provides operational oversight to the activities related to regulatory information management data and system maintenance, guiding the team ... and Global Regulatory Affairs (GRA) technology roadmap. + Promotes regulatory information quality, reporting, and development and monitoring of KPIs… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - ... notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems, preparing,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... from regulatory agencies. + Write procedures. + Effectively present information to internal and external clients. + Apply mathematical concepts to such… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director , Statistical Programming, provides functional expertise and ... of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation of innovative… more
- Penn Medicine (Hamilton, NJ)
- …Our employees shape our future each day. Are you living your life's work? Associate Medical Director Summary: + To provide high quality comprehensive clinical ... participates in the psychiatric on-call system. In collaboration with the Medical Director for the Outpatient Site, provides clinical and administrative oversight of… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for Associate Director , RA Submissions. The position can be located on-site/hybrid in the US (Titusville, NJ; ... product development process. + Proficiency in the use of Regulatory Information Systems, and submission planning and publishing tools + Proficiency… more
- Penn Medicine (Plainsboro, NJ)
- …that the department is run according to institutional policies and any applicable regulatory requirements. The Associate Director assists and supports the ... Are you living your life's work? Summary: + The Associate Director is responsible for overseeing staff,...and implements departmental policies and procedures to comply with regulatory requirements as well as pharmacy best practices. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director of Specialty Laboratory Quality is responsible for ... laboratory audit program, with an emphasis on risk-based management, regulatory strategy development (ie, fit-for-purpose), and monitoring the regulatory… more
- Bristol Myers Squibb (Princeton, NJ)
- …diagnostics (CDx) biomarkers in support of the BMS portfolio. **Summary** The Associate Director of Diagnostic Sciences provides subject matter expertise related ... that enhance value of the pharmaceutical product profile. BMS is seeking an Associate Director of Diagnostic Sciences to fulfill this critical role. **MAJOR… more
