- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Compassionate Use or Managed Access Programs.Collaborate with the Sr Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring ... in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and… more
- Insmed Incorporated (NJ)
- …Education in compliance with internal processes.Provide strategic medical support to Drug Safety for any product alerts in the US.Provide strategic support ... the future of science, we're in. Are you?About the Role:The Medical Director, Medical Affairs - Dermatology role will be responsible for supporting the product … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Create job-specific training curricula for different roles within clinical operations, medical affairs , and regulatory affairs Maintain training assignments ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...years of experience in pharmaceutical training, clinical research, or regulatory affairs Strong knowledge of clinical research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree in a related field is preferred 10+ years of experience in pharmaceutical, regulatory affairs , or compliance roles, with a strong background in patient ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs , etc.); advanced degree preferred 7+ years of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …governance meetings Lead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs , IT, and Global Units Manage change initiatives ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …preferred) 3+ years of experience in pharmaceutical training, clinical research, or regulatory affairs ATD certification a plus Proficient knowledge of adult ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Sanofi (Morristown, NJ)
- …well as Pre-Clinical & Clinical Development, Regulatory Affairs , Medical Affairs , Legal and Global Business Units Provides safety expertise, disease and ... guidelines Expertise in signal detection / evaluation methodologies related to drug safety information throughout the product life cycle Applying biostatistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date ... programs, including off-target effects, immunogenicity, insertional mutagenesis, and long-term safety .Participate in the development of target product profiles… more
