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Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
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Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Quick apply
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Quick apply
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Quick apply
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Quick apply
Assists with business development and capabilities efforts as needed. * Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client ...
Provide medical input into the development and execution of study documents and plans, such as ... Lead safety activities on assigned product(s) that may include interactions with other functional ...
Provide medical input into the development and execution of study documents and plans, such as ... Lead safety activities on assigned product(s) that may include interactions with other functional ...
Provide medical input into the development and execution of study documents and plans, such as ... Lead safety activities on assigned product(s) that may include interactions with other functional ...
Provide medical input into the development and execution of study documents and plans, such as ... Lead safety activities on assigned product(s) that may include interactions with other functional ...
Provide medical input into the development and execution of study documents and plans, such as ... Lead safety activities on assigned product(s) that may include interactions with other functional ...
Provide medical input into the development and execution of study documents and plans, such as ... Lead safety activities on assigned product(s) that may include interactions with other functional ...

Full-time
Posted 2 days ago
New
Position Summary
The REMS Business Analyst serves as the critical liaison between business stakeholders, sponsors, and IT teams to ensure the successful delivery of Risk Evaluation and Mitigation Strategy (REMS) programs and supporting REMS solutions. This role is responsible for gathering, analyzing, and translating client requirements into detailed business and functional requirements, while coordinating cross-functional projects to ensure compliant REMS websites and technology solutions are delivered on time, and in accordance with regulatory requirements.
Key Responsibilities
Business Analysis & Requirements Management
Partner with clients and internal stakeholders to gather, document, and validate business requirements for REMS programs and related technology solutions.
Analyze client needs and translate them into clear, actionable business requirements for IT development teams.
Develop and maintain requirement documents, user stories, process flows, use cases, and functional specifications.
Facilitate requirements review sessions and obtain approval for project deliverables.
Identify gaps, risks, and opportunities for process improvement within REMS-related systems and workflows.
Project Coordination & Delivery
Coordinate multiple concurrent projects and initiatives involving IT, compliance, operations, and business stakeholders.
Collaborate with project managers, developers, quality assurance teams, and business owners to ensure project milestones and deliverables are met.
Track project risks, issues, and dependencies, escalating concerns as appropriate.
Support user acceptance testing (UAT) activities and ensure solutions meet business and compliance requirements prior to deployment.
Compliance & Website Implementation
Partner with IT teams to deliver REMS websites and technology solutions that meet regulatory, client, and organizational requirements.
Ensure implemented solutions align with compliance standards, business objectives, and established quality expectations.
Participate in validation and change management processes to support compliant system implementations.
Monitor system enhancements and website updates for regulatory and business impacts.
Stakeholder & Cross-Functional Collaboration
Serve as the primary point of contact between business teams, IT, compliance, and operational stakeholders.
Build strong working relationships across internal departments to facilitate effective communication and project execution.
Lead meetings and requirement gathering sessions with diverse stakeholder groups.
Communicate project status, requirement changes, and implementation of updates to stakeholders at all levels.
Qualifications
Required
Experience gathering and documenting business requirements and translating them into technical requirements.
Strong project coordination and organizational skills with the ability to manage multiple priorities simultaneously.
Excellent verbal and written communication skills.
Ability to effectively interact with clients, IT teams, and cross-functional business partners.
Strong analytical, problem-solving, and critical-thinking skills.
Preferred
Experience working in REMS, pharmaceutical, healthcare, or life sciences environments.
Knowledge of software development lifecycle (SDLC) methodologies.
Familiarity with website implementation projects.
Knowledge of regulatory and compliance requirements within the healthcare or pharmaceutical industry.
Key Competencies
Requirements Gathering & Analysis
Business Process Mapping
Project Coordination
Cross-Functional Collaboration
Risk Identification & Mitigation
Regulatory Compliance Awareness
Communication & Presentation Skills
Problem Solving
This role is ideal for a professional who can bridge the gap between business needs and technical execution while ensuring REMS technology solutions are delivered efficiently, compliantly, and successfully.
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Pharmaceutical and medicine manufacturing
1 - 10 Employees
Los Angeles, CA, US
1980