REMS Operations & Implementation Lead

J
JobgetherLife Sciences
Based in the United StatesFull-TimeLead
Salary not disclosed
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Job Details

Required Skills
Business AnalysisProject Coordination

Requirements

  • Demonstrated experience gathering, analyzing, documenting, and translating business requirements into detailed technical or functional requirements.
  • Strong project coordination, organization, and prioritization skills, managing multiple initiatives and deadlines.
  • Excellent written and verbal communication skills across client, technical, and business stakeholder groups.
  • Strong analytical, critical-thinking, and problem-solving capabilities.
  • Demonstrated ability to bridge business needs and technical execution while maintaining focus on quality and compliance.
  • Experience working collaboratively with IT, development, quality assurance, and project management teams.
  • Experience in REMS, pharmaceutical, biotechnology, healthcare, clinical research, or life sciences environments is strongly preferred.
  • Familiarity with software development lifecycle (SDLC) methodologies and technology implementation processes is desirable.
  • Experience with website implementation projects is a plus.
  • Knowledge of healthcare or pharmaceutical regulatory and compliance requirements is preferred.

Responsibilities

  • Partner with clients, sponsors, and internal stakeholders to gather, analyze, document, and validate business requirements for REMS programs.
  • Translate business needs into clear and actionable technical and functional requirements for IT and development teams.
  • Create and maintain requirement documentation, user stories, process flows, use cases, and functional specifications.
  • Facilitate requirements workshops and review sessions to ensure stakeholder alignment.
  • Identify requirements gaps, project risks, dependencies, and process improvement opportunities.
  • Coordinate multiple concurrent projects involving IT, compliance, operations, and QA teams.
  • Support user acceptance testing (UAT) to verify compliance before deployment.
  • Collaborate with IT teams on the implementation and enhancement of REMS websites and technology solutions.
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