Regulatory Submissions Specialist

| New York City, NY | Hybrid
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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 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 (e.g., clinical oncology, cardiology, infectious diseases, psychiatry) and associated regulatory frameworks.

Responsibilities:

  • 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.

Required Qualifications

  • 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.

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
  • 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.

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Technology we use

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An Insider's view of Tempus AI

What’s the vibe like in the office?

The casual setting here in the Chicago office makes everyone less intimidating and more approachable. It's nice to be in an environment where our day-to-day work actually makes a difference, I feel valued. Tempus is also great at welcoming everyone with different backgrounds.

Alexis

Clinical Lab Associate

How do you collaborate with other teams in the company?

I collaborate with various hiring teams on a daily basis. Through weekly meetings, strategic planning, events, and messaging, hiring teams and I have built a collaborative hiring process and have become trusted partners to bring top talent to Tempus. We rely on honest communication, shared goals, and the right tools to set us up for success!

Emma

Recruiter

What makes someone successful on your team?

We value creativity in ideation, autonomy in execution, and a healthy tendency to always question the status quo.

Ash

Lead Data Scientist

What are some things you learned at the company?

One of the things that molded my growth was seeing how much thought goes into the decisions, and how much leadership seeks feedback from the people around them, to help understand the impact of decision-making. Just being a sponge in the room is inspiring. I adapted the styles of many leaders here and use that to create my own leadership style.

Anita

Laboratory Operations Manager

What are Tempus AI Perks + Benefits

Tempus AI Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Employee Assistance Program (EAP)
Pet Insurance
Company Cafeteria with Breakfast, Lunch & Grab & Go Options
Stocked Kitchen with Snacks
On-Site Barista
Discounted Gym Membership
Discounted Divvy Membership
Diversity & Inclusion Initiatives
Team & Company Outings

Culture
Volunteer in local community
Open door policy
OKR operational model
Team based strategic planning
Pair programming
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
Flexible work schedule
Remote work program
Diversity
Highly diverse management team
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Pet insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
Company equity
Charitable contribution matching
Child Care & Parental Leave Benefits
Generous parental leave
Family medical leave
Vacation & Time Off Benefits
Unlimited vacation policy
Generous PTO
All staff in Tempus’ laboratories are subject to Tempus’ separate laboratory PTO policies.
Paid volunteer time
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Office Perks
Commuter benefits
Company-sponsored outings
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Meditation space
Mother's room
Onsite gym
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

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