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.
We are looking for a key contributor for IVD projects in the generation of design documents, reports, SOPs, and other documentation towards the development of diagnostic assays. The position involves applying experience in quality and regulatory documentation to support the molecular R&D group in drafting documentation for regulatory submissions. You will work closely with Technical and Development Scientists, technologists, as well as Quality and Regulatory professionals.
What you’ll do:
Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing
Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes
Track batch records and checklists produced during IVD clinical validations and ensure compliance
Maintain appropriate filing systems
Documentation review for consistency and compliance
Help oversee implementation of new documentation and version control
Serve as a point of contact for documentation retrieval
Aid in preparation for internal and external audits
Manage multiple sources of information for documentation purposes
Help to continuously improve IVD and LDT development documentation and processes
Qualifications:
Bachelor’s degree plus 2+ years of documentation experience in the medical device industry
Organized and detail oriented
Excellent written and verbal skills
Ability to work well will cross functional teams
Team driven
Highly desirable:
Experience in a lab setting in life sciences and a thorough understanding of molecular biology and associated techniques
Ability to thrive in a fast paced environment
Familiarity with a range of QMS systems and regulatory submissions
Familiarity with ISO 13485 and FDA QSMR
#LI-DA1
CHI: $50,000-$65,000
The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Skills Required
- Bachelor's degree
- At least 2 years of documentation experience in the medical device industry
- Strong organizational and attention-to-detail skills
- Excellent written and verbal communication skills
- Ability to collaborate effectively with cross-functional teams
- Team-oriented approach
- Laboratory experience in life sciences
- Understanding of molecular biology and associated techniques
- Ability to work in a fast-paced environment
- Familiarity with quality management systems and regulatory submissions
- Familiarity with ISO 13485 and FDA QSMR
What the Team is Saying
Tempus AI Compensation & Benefits Highlights
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, plus mental‑health resources and HSA/FSA options, with core items employer‑verified in mid‑2026.
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Leave & Time Off Breadth — Paid time off and parental leave are consistently part of the package, with parental leave commonly cited around three months and related pages noted as recently employer‑verified.
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Wellbeing & Lifestyle Benefits — Everyday perks such as commuter benefits, on‑site meals and coffee programs, gym discounts, charitable matching, ERGs, pet insurance, and team events are widely highlighted, with some amenities available in select offices.
Tempus AI Insights
What We Do
We bring together one of the world’s largest libraries of multimodal clinical and molecular data with a robust suite of AI tools to help physicians personalize care in real time, connect patients with therapies and clinical trials, and enable partners to accelerate discovery and development of new treatments. With ~8 million de-identified research records and 350+ petabytes of data, Tempus partners with more than half of U.S. oncologists and the majority of the top 20 global pharma companies. Our teams are pioneering work across oncology, neurology, psychiatry, cardiology, and beyond—transforming how care is delivered and therapies are developed. At Tempus, every role contributes to our mission: to help each patient benefit from the experiences of those who came before. For more information, visit tempus.com.
Why Work With Us
We’re looking for people who can change the world. People who question the status quo and refuse to shy away from tough problems. For builders who are never done building, and the learners who are never done learning. Passionate individuals with undying curiosity who want to take on one of the greatest challenges humanity has ever faced—head on.
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Tempus AI Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Most of the team follows a hybrid policy, with some roles allowing for a fully remote arrangement and some roles being onsite only.
