and mentorship to junior staff or specialists on assigned projects. Requirements: Bachelor's degree in Regulatory Affairs, Life... Sciences, Engineering, or a related field. 4–6 years of regulatory affairs experience in the medical device or IVD industry...
management, particularly in the oncology field. Requirements: Bachelor's degree in Life Sciences, Computer Science...
most important research questions across clinical development, market access, and commercial use cases for our life sciences partners... (e.g., PhD, ScD, DrPH) in Biostatistics/Statistics, Data Science, Bioinformatics, Biological Sciences, Public Health, Math...
Sciences, Regulatory Affairs or other relevant fields. 3 - 5 years of experience in authoring CMC sections of regulatory...
(k) clearances and CE marking is required. Strong understanding of medical device product life cycle and regulatory requirements...
standards (e.g., ICH-GCP, CDISC). Requirements: Bachelor's degree in a life science, health science, pharmacy, public health...
and ADaM. Proven experience with Unix and Windows operating systems. Understanding of the software development life cycle...
initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track...
Roles & Responsibilities: Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Mathematics, Computer Science, or related applicable field. Minimum of 5 to 8 years' SAS programming experience in the p...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cr...
Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation, review, completion, and delivery of...
Responsibilities: Responsible for the oversight of all data management CRO activities supporting company's clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM ...
Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirem...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working un...