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    Tempus Labs
    Posted over 2 years ago

    Senior Manager of Quality, PMS & Complaints

    Chicago, Illinois, United States, IL

    Job Description

    Passionate about precision medicine and advancing the healthcare industry?

    Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

    The ideal candidate for Sr. Manager, Quality Engineering will have experience in the areas of FDA QSR (21 CFR 820), ISO 13485, ISO14971, IVDD/IVDR, as well as CLIA, CAP, NYSDOH. This role will support product quality during clinical studies and from launch to End of Life. Responsibilities include oversight of all postmarket surveillance (PMS) activities including complaint intake and record processing, failure investigations, adverse event reporting, complaint trending and signal detection, product concerns, and “field” action activities. This individual is also responsible for postmarket or operational activities, including drafting plans and reports as well as the communication of postmarket information with ...

    The Real Dill ☘️

    Drug development is hard - Big Pharma wouldn't be a $1 TRILLION+ industry if it wasn't. From end to end development, some estimates show nearly a decade of work and $1B of investment is needed to bring a single drug to market, not to mention the incredible attrition rate of molecules that don't pass muster to progress from preclinical to Phase 1/2/3 clinical trials and regulatory approval. Three of the biggest challenges facing the drug development industry in increasing the success rate of bringing drugs to market are the focus of Tempus Labs: drug discovery (finding new molecules to develop), clinical trials (verifying the usage and viability of turning molecules into medicines) and diagnostics (finding the right patients to take each highly complex, specialized drug being developed). It makes sense that these processes could be opportunities for artificial intelligence to accelerate the process - helping doctors understand disease progression by finding the right patients for a trial, etc. Startups in this space are raising ludicrous amounts of money (Tempus Labs itself has raised over $1B) which is a startling contrast to the adjacent digital health space where companies are striving for overall valuations in the $1B ballpark...it's a different game, with different players, and, in some ways, even more competitive. (September 2023)

    JL

    Jon Lee, PT, DPT, OCS, FAAOMPT, MBA

    Pickle co-founder

    About Tempus Labs

    Advancing precision medicine through the practical application of artificial intelligence in healthcare.

    🚀

    MissionFor each patient to benefit from the treatment of others who came before by providing the healthcare industry tools that learn as we gather more data.

    🌟

    Wow FactorClaims >90% of the top 20 Pharma companies partner with Tempus

    Company benefits

    • 🔐 Health insurance
    • 🦷 Dental
    • 👀 Vision
    • 🤕 Short-term disability benefit
    • 🐣 Maternity/paternity leave
    • 🐶 Pet benefits
    • ✈️ Travel stipends
    • 💰 Life insurance

    Pickle is not affiliated with listed companies unless otherwise noted.

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