Regulatory Submissions Specialist

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 seeking an independent and motivated Regulatory Submissions 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 and associated regulatory frameworks.

Responsibilities:

• Conduct research to inform regulatory strategies and maintain high level of regulatory intelligence.
• Prepare and submit documents to regulatory authorities in the US and globally.
• 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. 

Required Qualifications:

• Degree in biomedical/life sciences or a similar field, or significant, and/or relevant scientific/medical writing and/or FDA experience. 
• Minimum of 3+ years of experience in Regulatory Affairs experience related to medical devices
• 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.

Preferred Qualifications

• Experience writing documents submitted to the FDA or other regulatory bodies, e.g., IND, CTA, NDA, BLA, IDE, PMA, 510(k), CTA, etc.
• Strong attention to detail.
• Ability to thrive in a fast paced, dynamic environment.
• 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.