Regulatory Affairs Specialist at Tempus
Recent advancements in healthcare technology have made it possible for AI to impact clinical care in a meaningful way. Tempus’ proprietary platform connects an entire healthcare technology ecosystem to deliver real-time, actionable insights to physicians. Our platform and data drive individualized care, empower researchers to better characterize diseases for improved patient outcomes, and accelerate healthcare innovation and discovery.
We are seeking an independent and motivated Regulatory Affairs Specialist to work with our growing Regulatory Affairs team. This individual is a clear communicator, effective collaborator, and proactive problem solver interested in impacting patients’ lives through scientific and medical communications. This individual will collaborate with interdisciplinary teams to communicate important research and clinical capabilities of the Tempus platform to regulatory bodies. The regulatory specialist will have the opportunity to learn about our cutting-edge healthcare technology in various disease areas (e.g., clinical oncology, cardiology, infectious diseases, psychiatry) and associated regulatory frameworks.
- Prepare documents to submit to government and/or other regulatory bodies (e.g., FDA, CMS, etc.).
- Generate technical documentation and tailored materials for internal teams (e.g. Commercial, R&D), external clinical and research partners, and regulatory agencies.
- Manage document writing and review processes, including timelines for document generation, submission, revision, and completion.
- Liaise and collaborate with key stakeholders to ensure timely delivery and quality of writing deliverables.
- Partner and collaborate with the regulatory affairs team on project timelines and submissions.
- Degree in biomedical/life sciences or a similar field, or significant, and/or relevant scientific/medical writing and/or FDA experience.
- Experience leading the execution of technical documents, along with a track record of success, as well as regulatory submissions
- Strong organizational and prioritization skills with a demonstrated ability to work on multiple projects and excel in an ambiguous, rapidly changing environment.
- Demonstrated proactive leadership, project/time management and problem-solving abilities.
- Basic to intermediate knowledge of next-generation DNA and RNA sequencing, clinical research concepts, and/or oncology.
- Ability to interpret, analyze, and summarize primary scientific/medical literature for a range of audiences and assist with facilitation of the submission process.
- Experience writing documents submitted to the FDA or other regulatory bodies, e.g., IND, CTA, NDA, BLA, IDE, PMA, 510(k), CTA, etc
- Experience with/knowledge of genomics, bioinformatics and computational biology (e.g., statistics, predictive modeling algorithms).
- Experience with/knowledge of healthcare technology, personalized medicine, and/or related fields.
- Experience using Google Drive and Microsoft Powerpoint, Excel, and Word.
- Experience managing projects in a cross-functional setting.