Responsibilities: A deep appreciation of Drug safety, FDA REMS program requirements and key processes. Develop and gather the material and guide the Purdue team for the future REMS Inspections. Attend and actively participate on various...
Job Description: Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 C...
Responsibilities and Requirements: Experience in Tealium. JavaScript and React experience. Experience in Tagging on a website Responsible for preparing and executing test documentation for GMP computerized systems as well as providing ...
Responsibilities: Either collect, advise, or create documentation and include it in an IT Process Repository. Engage with IT process owners to document processes, including 1) process flows diagram 2)RACI charts, and 3) any glossary defi...
Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports. Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers. ...
Responsibilities: 8 years hands on statistical programming experience in the pharma/biotech industry Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, and SAS Macros, preferrable experience using R. Desire ...
Responsibilities and Requirements: 6+ years' experience of Regulatory Affairs product labeling in the pharmaceutical industry. Strong background authoring or updating content and text for CCDSs, EUPIs, USPIs for product labeling fro...
Description: Seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant! T...
Responsibilities: Senior R programmer with RWD experience and required experience in CMS data (Medicaid, Medicare, etc). As a Senior Programmer/Analyst, Real-World Data and Analytics, you will conduct hands-on programming (expert level f...
Responsibilities: While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. The physical demands described here are representative of those that must be met by an em...
Responsibilities: · Lead the generation of key deliverables in a phase appropriate compliance manner as part of global CQV strategy for F&U, Equipment, QC/Analytical, Cleaning and Shipping · Support development of robust collaboration for...
Responsibilities : The Senior Global Labeling Coordinator is responsible for providing advanced specialized operational support to the RA GL Manager, GL-TAL and Head GL related to the creation and maintenance of core labeling packages for...
Responsibilities : In close partnership with the regional strategists / liaisons, develop strategic and operational plan for the development and the registration of assets across IN&F. Lead and/or support marketing application submission...
QUALITY ANALYST: • A minimum of 4-6 years of related experience. Must have Process Validation experience. Good technical understanding of manufacturing equipment and processes. Knowledge of statistical software packages (e.g. Minitab) wi...
Responsibilities (include but are not limited to): Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays. Work with internal and e...
RESPONSIBILITIES: Serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures...
Responsibilities and Requirements: Looking for an R statistical programmer/analyst to support a small biotech. There is not a computing environment set up yet so the person will use the RStudio desktop app and leverage R (like R Shiny) f...
Responsibilities: Creates standard and/or custom programs/reports using data analytics tools such as SAS, or other data visualization tools to support data oversight and review by data managers or other data reviewers. Collaborates with ...
Job Description: Clinical Scientist Responsible for the translation and implementation of (non-medical) scientific concepts into the study design and/or program across planning, execution, and reporting, including integration of biomark...