's degree in life sciences, pharmacy, health sciences, or a related field. 2+ years of experience in regulatory affairs...
programmers and external vendors. Requirements: Bachelor's degree in computer science, Statistics, Mathematics, Life Sciences...
to the development and validation of data management software tools. Requirements: BSc or MSc in Life Sciences, Data...
of regulatory responses and may participate in meetings. Requirements: Bachelor's degree in the sciences; advanced degree (e.g...
. Strong understanding of medical device product life cycle and regulatory requirements. In-depth knowledge of ISO 13485, FDA regulations...
. Prepares documents vital for new product market clearance, approval, and continuance during product life cycle management...
successful 510(k) clearances and CE marking is required. Strong understanding of medical device product life cycle and regulatory...
Job Description: Role is responsible for designing, planning, and executing large scale data analysis, and algorithm development to identify gaps in the care continuum and to measure impact using RWD. This work highlights the value of ut...
Responsibilities: The Regulatory Affairs Specialist for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality Management System...
Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Abil...
Job Description: Experienced Mechanical Design & Manufacturing Engineer with proven expertise in the design, development, and validation of plastic, casting, and sheet metal components - including mold design. Adept at managing end-to-end ...
Responsibilities: Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensur...
Job Description: With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and...
Job Description: We're looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Use statistical programming software to develop datasets and tables, figures, and listings tha...
Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check...
Responsibilities: Develop and maintain SAS programs to import, clean, and validate clinical trial data. Use R for data manipulation, analysis, and visualization. Perform statistical analyses in accordance with study protocols and analys...
Responsibilities: Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to ...
Responsibilities: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Dev...
Responsibilities: Perform validation and QC of the programs, datasets and statistical reports per study requirements. Develop and review CDISC SDTM and ADaM mapping specifications. Responsible for study closeout and providing submission...
Responsibilities: Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs. Program and QC tables, listings, and f...