- Eisai, Inc (Raleigh, NC)
- …, Western SCM Unit is also instrumental in supporting the various Business Development Due Diligence efforts and negotiations (in and out-licensing).The ... The Global Supply Chain function collaborates with Regional (Americas, EU , and JP) Commercial, Financial & Supply Business...SCM Unit is also instrumental in supporting the various Business Development Due Diligence efforts and negotiations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and strategic quality guidance/advice to the MA functions located in the Americas and EU and collaborate with Research QA and Development QA to provide QA ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure consistent compliance practices.Collaborate effectively with IT to align system development with business and regulatory expectations. Review systems for ... other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high… more
- Merck & Co. (Rahway, NJ)
- …Management objectives and build QMS capabilities that touch every aspect of our business processes, systems, and data.The Associate Director will collaborate and ... As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provide input and updates within internal cross-functional teams (eg, Diagnostic Development Teams) and to external diagnostic business partners specifically:Use ... immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong … more
- Eisai, Inc (Nutley, NJ)
- …to ensure effective achievement of regulatory/ business objectives. The Executive Director will direct the development and submission of investigational drug ... and oncology, with a strong emphasis on research and development . Our history includes the development of...want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development , validation, implementation, and integration of GxP-regulated systems across the ... Leads and Technical Leads to ensure validation and technical implementation align with business priorities, GxP regulations (eg, Part 11), laws (eg, GDPR), and DS… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be responsible for the development ... (IFU) documents and Device Container Labeling content in line with US and EU standards and guidelines. Provide strategic and tactical labeling expertise to teams… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for the ... development and implementation of labeling content and strategy of...or creation of a new TLP, CCDS, USPI and EU SmPC. **How you will contribute:** **Management of Labeling… more
- J&J Family of Companies (Raritan, NJ)
- …Management** : Using strong methodologies, create pertaining project plans, including budget development (CAR creations). Lead in developing business case(s) for ... member of Johnson & Johnson Family of Companies, is recruiting for a Director , Strategic Capabilities - Packaging Environmental Compliance in Raritan, NJ Please note… more
- Takeda Pharmaceuticals (Boston, MA)
- …Leads the Global Development Team (US, EU , Japan) managing both the US/ EU Development Team and the Japan Development team for assigned compounds. In ... some cases may lead the US/ EU Development Team but more likely will...the successful completion of related objectives. + **Due Diligence, Business Development and Alliance Projects** + Responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …Emerging Markets (GEM; eg, China), Project Leadership, Finance, Corporate Communications and Business Development + Develop and manage strong collaborations with ... Drive value demonstration strategies for Health Technology Appraisal (HTA; including the EU Joint Clinical Assessment [JCA]) and payer assessments to optimize rapid,… more
- AbbVie (Waltham, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Oncology Business Development and Global Regulatory ... global strategies in line with applicable regulations to achieve business objectives for development and marketed products....as EU or Japan. Strong global drug development foundation with business acumen. + Note:… more
- Arvato Bertelsmann (Demotte, IN)
- Arvato is hiring a self-motivated and entrepreneurial-minded Director of Business Development to join our growing team! In this role, you will be able to ... warehousing, retail distribution and end-to-end supply chain solutions. * Work with Business Development , Marketing, Solution Design and Logistics Engineering on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we ... matters, and everyone has a chance to enhance their skills through ongoing development . Our scientific focus has resulted in marketed products that are benefiting… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and strategic quality guidance/advice to the MA functions located in the Americas and EU and collaborate with Research QA and Development QA to provide QA ... rare diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV...aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit… more
- Abbott (Santa Clara, CA)
- …Oversee development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files + Manage relevant standards and ... Our 114,000 colleagues serve people in more than 160 countries. ** Director , Biocompatibility** **Position Summary** Responsible for Biocompatibility support to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Global Development Team (US, EU , and others) managing both the US/ EU Development Team and the Japan/ China Development team for assigned ... compounds. In some cases may lead the US/ EU Development Team but more likely will...nominations and reviewers of external compounds as part of business development efforts + Liaison with Clinical… more
