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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