Regulatory Specialist

Helping match patients to clinical trials faster.

Deep Lens is a digital healthcare company focused on a groundbreaking approach to faster recruitment of the best-suited cancer patients to clinical trials. Through an innovative mix of technology and services, Deep Lens aims to compress clinical trial study timelines for clients allowing them to bring novel ground-breaking therapies to market faster.

We are a highly collaborative team and lean on the collective experience of each and every team member to move quickly as we build software and services that meet the needs of our customers.

 

Job Description

The Customer Success team at Deep Lens, Inc. is seeking an experienced Regulatory Specialist.  This role is responsible for collecting, organizing and maintaining all regulatory documents within the Deep Lens Unity Network, IRB related submissions, and working closely with provider care teams and internal resources to meet project-specific needs. 

The successful candidate will achieve success by establishing and implementing processes and procedures, while having a clear understanding of the clinical trials process and a background working with care teams across multiple organizations.  All processes should enable the Deep Lens team to scale these efforts to our growing network of clinical practices, while maintaining flexibility to meet the varying needs of the network.

 

Key Roles and Responsibilities:

  • Collaborates with practice level research teams and Customer Success Program teams
  • Maintains Regulatory Trial Master Files
  • Coordinates submissions to regulatory bodies and agencies 
  • Assists with contracts and budgets 
  • Continually develops knowledge and skill to strengthen job performance
  • Handles sensitive and confidential information with tact, discretion, and judgment
  • Performs other related duties as required and assigned

Skills Required:

  • Understanding of applicable federal and state regulations
  • Strong organizational skills
  • Experience managing multiple concurrent projects
  • Excellent written and communication skills
  • Strong interpersonal skills to facilitate working within a team and build relationships with the customer
  • High degree of responsiveness, reliability, and integrity
  • Decisiveness, strong judgment, analytical, and problem-solving skills
  • Excellent time-management skills
  • Willingness to travel up to 10%-20% if required

Education / Experience Required:

  • 5 years experience in the clinical trial regulatory space required

Job Type

  • Full-time

Work Authorization

  • United States (Required)

Location

  • Remote

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