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Full-Time

Medical Monitor

Confirmed live in the last 24 hours

Fractyl Health, Inc

Fractyl Health, Inc

51-200 employees

Develops therapies for type 2 diabetes management

Hardware

Senior, Expert

Burlington, MA, USA

Category
Healthcare Administration & Support
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Communications
Requirements
  • MD or equivalent required
  • Minimum of 5 years direct experience in the medical device industry
  • Proficient with ICH Good Clinical Practice guidelines
  • Experience in type 2 diabetes and/or metabolic disorders
  • Strong interpersonal and communication skills
  • Experience using electronic documentation management system
  • Ability to work independently or with a team
Responsibilities
  • Work as primary Medical Monitor for assigned clinical trials
  • Develop and/or review medical monitoring and safety plans
  • Provide final review and approval of safety narrative
  • Conduct literature reviews for regulatory submissions
  • Consult with stakeholders to assist in the development of clinical trials
  • Work closely with the clinical team to develop/edit clinical documents
  • Perform all activities in compliance with regulations and company policies

Fractyl Health is pioneering Revita, an endoscopic procedural therapy that targets the root causes of type 2 diabetes by remodeling the duodenal lining via hydrothermal ablation. They are also developing Rejuva, a novel pancreatic gene therapy platform aimed at restoring insulin production and islet function in patients with advanced type 2 diabetes.

Company Stage

IPO

Total Funding

$395.4M

Headquarters

Lexington, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

15%

1 year growth

19%

2 year growth

30%