Risk Management and Compliance Specialist

2 weeks ago


Stamford, Connecticut, United States Morph Enterprise Full time
Position Overview

We are seeking a knowledgeable professional to join our team as a Risk Management and Compliance Specialist. This role is essential in ensuring that our risk evaluation and mitigation strategies align with industry regulations and standards.

Key Responsibilities
  • Expertise in Risk Management: Demonstrate comprehensive understanding of Risk Evaluation and Mitigation Strategies (REMS) and produce detailed REMS Assessment reports.
  • Regulatory Knowledge: Possess in-depth knowledge of FDA regulations and compliance requirements.
  • Experience: A minimum of 5 years in the pharmaceutical industry, with a focus on drug safety, risk management, or epidemiology, including at least 2 years of direct involvement in REMS.
  • Audit Management: Proven experience in managing REMS audits effectively.
  • Direct Involvement: Engage directly in REMS activities and initiatives.
  • Subject Matter Expertise: Act as a subject matter expert on REMS, providing guidance and support to the team.
Contract Details

Contract Duration: 5-6 months

Work Hours: Flexible hours within the EST time zone, typically between 8 AM - 5 PM or 9 AM - 5 PM, Monday to Friday.

Work Environment

Location: This position is remote, with the possibility of an occasional on-site visit for mock inspections.

Interview Process

The selection process will consist of two rounds of interviews conducted via Teams, each lasting approximately 30 minutes.

Desired Qualities

The ideal candidate will possess:

  • Insight into vendor management and project management operations.
  • Direct experience in preparing for regulatory inspections.
Team Collaboration

This role reports to the hiring manager and collaborates closely with a physician and a scientist on a daily basis. Additionally, the position involves cross-functional teamwork with the Medical Affairs and Quality departments.



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