- Taiho Oncology (FL)
- …MS, PR, AL Formally known as Medical Science Liaison Position Summary: The Sr. Manager , Medical Field is a field-facing representative of the Medical Affairs ... relevant disease states, and facilitation of clinical research. The Sr. Manager , Medical Field integrates clinical/scientific expertise and knowledge to ensure… more
- Katalyst HealthCares and Life Sciences (Newark, NJ)
- Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for ... report to the Sr. Director QRC responsible for microbiology quality , regulatory, and clinical. If you thrive in an...indications within a Therapeutic Area and supports the Sr. Manager Clinical Affairs in the development &… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This Regulatory Affairs Manager position is an onsite opportunity working out of ... 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or… more
- Kyowa Kirin North America (Princeton, NJ)
- …offices in California, North Carolina, and Mississauga, Ontario. Summary: The Project Manager , Global Regulatory Affairs Compliance and Planning will lead or ... monitoring and reporting of project performance. Essential Functions: The Project Manager , Regulatory Affairs Global Compliance and Planning is responsible… more
- Katalyst HealthCares and Life Sciences (Southern Md Facility, MD)
- …all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory ... sciences or engineering, or other technical discipline. 6 years of Regulatory affairs job experience in the medical device industry. Technical or Medical Writing… more
- Amazon (Bellevue, WA)
- …our customers and employees. We are looking for a Principal, Audit Project Manager to oversee audit activities across Amazon's Worldwide Operations with a focus on ... objectives of WHS. You must be a strong project manager who can manage end-to-end audit projects and borrowed...lead auditors to help them scope, plan and execute high- quality and impactful audits, which address the most important… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, ... rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global...will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for… more
- Axsome Therapeutics (New York, NY)
- …self-motivated Medical Writer to draft, edit and submit high quality , medically accurate documents including manuscripts, conference abstracts, posters, slide ... additional field materials, and publication enhancers. This is a key position within Medical Affairs with ample opportunity to make a real impact. This role is based… more
- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- …Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and ... with the dynamic regulatory landscape, especially in CMC and quality aspects. Expertise in ICH, EMA and FDA guidelines....EU, China, Japan, APAC, LATAM and EMEA. Expertise in quality guidelines of ICH, FDA and EMA. Demonstrated ability… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
