- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Insmed Incorporated (San Diego, CA)
- …software for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is ... on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping… more
- Twist BioScience (South San Francisco, CA)
- …teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design seamless ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... differentiation.Collaborate with our Global Marketing, Clinical Development, and Government Affairs on the go-to-market strategy for the preclinical indication and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... pull you in? Are you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in shaping an insights-driven consumer… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Pall (Miami, FL)
- …and innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance...of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100… more
- Novo Nordisk Inc. (San Francisco, CA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Cytokinetics (South San Francisco, CA)
- …contractility. Job purpose Cytokinetics is seeking an experienced and highly motivated Senior Director , Regulatory Affairs to join the Global Regulatory ... that the latest regulatory requirements and industry standards are met. The Senior Director , Regulatory Affairs will lead the Global Regulatory Team… more
- Piper Companies (Minneapolis, MN)
- Piper Companies is seeking an Associate Director , Regulatory Affairs to join a top biotechnology company in Minneapolis, MN. Responsibilities of the ... Associate Director , Regulatory Affairs : Lead ...Biotech, Pharmaceutical Development, 21 CFR 1271, 21 CFR 312, Regulatory Strategy, Regulatory Submissions, Quality … more
- Eli Lilly and Company (Indianapolis, IN)
- …over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical ... evaluate global CMC regulatory strategies in collaboration with other regulatory , manufacturing, quality and project personnel to enable timely completion… more
- Katalyst HealthCares and Life Sciences (Newark, NJ)
- …team and report to the Sr. Director QRC responsible for microbiology quality , regulatory , and clinical. If you thrive in an amazing, multifunctional, ... Responsibilities: The Regulatory Affairs Manager is responsible for...regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier… more
- BioSpace (New York, NY)
- …within the organization. Cross-functional Collaboration: Work closely with clinical development, regulatory affairs , market access, and commercial teams to align ... Senior Director , and Lead Principal Scientist. Define a Medical Affairs organization in conjunction with our current Medical Scientific Liaison (MSL) team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARY The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA ... stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC...and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a… more
- RPM Research (Solana Beach, CA)
- Director , GLP Quality Assurance & Compliance.... 2+ years of managerial or supervisory experience in quality assurance, regulatory affairs , or ... of preclinical studies , we are seeking an experienced Director , GLP Quality Assurance & Compliance to...of In Vivo and In Vitro Research Operations Provide regulatory and quality oversight of in vivo… more
- Syneos Health Careers (Morrisville, NC)
- Description Associate Patient Recruitment and Retention External Account Director Syneos Health(R) is a leading fully integrated biopharmaceutical solutions ... built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.… more
