Thermo Fisher Scientific

Senior Compliance Specialist, FSP

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: Remote • North Carolina • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Leads small to mid-sized process improvement initiatives
  • Proactively conducts risk assessments and supports mitigation planning for improvement projects
  • Assists in updating and maintaining procedural documents
  • Provides recommendations for increased efficiency and compliance
  • Supports cross-functional teams in implementing process changes
  • Contributes to training programs and process governance discussions
  • Provides mentorship and guidance to developing team members
  • Represents the department as a prime contact on projects
  • Performs proactive evaluation of clinical trial processes

Requirements

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
  • MUST HAVE experience working within a GCP Environment
  • Solid knowledge of and experience in GCP compliance, regulatory inspection readiness
  • Solid knowledge of drug development, GCP compliance processes
  • Clinical research experience in all phases of clinical study life cycle preferred
  • Proficient in computer software programs such as Microsoft Office
Benefits
  • Competitive remuneration
  • Annual incentive plan bonus
  • Healthcare
  • Range of employee benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
process improvementrisk assessmentmitigation planningGCP complianceregulatory inspection readinessdrug developmentclinical study life cycleclinical research
Soft skills
leadershipmentorshipcommunicationcollaborationproblem-solving
Certifications
Bachelor's degree
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