- Merck & Co. (North Wales, PA)
- Job DescriptionJob DescriptionThe Director , Team Lead , Global Medical Information (GMI), is a member of the GMI Leadership Team and reports directly into the ... Senior Director , GMI Oncology. The role is headquarters-based within Global Medical and Scientific Affairs (GMSA) and is responsible for providing strategic and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies including ... regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Operations Leadership Team.ResponsibilitiesProvide oversight for all Global complex submissions (NDAs, INDs, BLAs, MAAs and supplements). Lead the ... areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory...and systems needed to build a core dossier for global submissions , they will liase with … more
- Merck & Co. (North Wales, PA)
- …for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Intelligence & Policy team, through direct and indirect line management, to identify and lead global corporate initiatives, ensuring that DS is prepared to meet ... for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …ability to define and communicate a compelling long-term vision and engage and lead global cross-functional teams to develop an aligned strategyPrior experience ... regulatory submissions (NDA, MAA, JNDA) with proven ability to lead multiple highly complex and/or high priority projects.Experience managing and/or leading… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the data services they provide to support drug development processes and global submissions . This position provides expertise within Data Management by ... employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes ... submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice, especially with respect… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Merck & Co. (Rahway, NJ)
- …the strategic planning and execution for product development and worldwide regulatory submissions . Lead a team of statisticians and the statistical programmers to ... of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities :Supervises a group of statisticians in Late Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables on time and within budget to support drug development processes and global submissions . This position provides leadership within Data Management by ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Director , Toxicology is accountable for managing the global ... individual has the necessary knowledge and experience to contribute to or lead early development cross-functional teams. The Director , Toxicology:Is a motivated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives ... visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description: The Director will be responsible for managing the product leaders and… more
