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Simpliigence · 2 days ago
REMS Business Analyst
United States
Contract
Remote
Mid Level
3+ years exp
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Hiring Manager
Pragna M.
Insider Connection @Simpliigence
Responsibilities
Business Process Analysis: Analyze and document business processes related to REMS programs. Identify areas for improvement and recommend solutions to enhance efficiency and compliance.
Requirement Gathering and Documentation: Collaborate with stakeholders to gather and document business and functional requirements for REMS programs. Translate business needs into clear, detailed requirements and specifications.
REMS Program Development: Assist in the development and design of REMS programs, ensuring alignment with regulatory guidelines and business objectives. Coordinate with cross-functional teams, including regulatory affairs, clinical, and legal, to ensure comprehensive program development.
Stakeholder Management: Serve as a liaison between business units, IT, and regulatory teams to ensure effective communication and collaboration. Facilitate meetings and workshops to discuss requirements, progress, and issues related to REMS programs.
Compliance and Risk Management: Ensure REMS programs comply with FDA regulations and other relevant guidelines. Monitor and assess risks associated with REMS programs and recommend mitigation strategies.
Testing and Validation: Develop and execute test plans to validate REMS program requirements. Ensure that all program components function as intended and meet user needs.
Training and Support: Provide training and support to internal teams and stakeholders on REMS program requirements and processes. Develop training materials and documentation as needed.
Reporting and Documentation: Prepare detailed reports, presentations, and documentation related to REMS program status, risks, and outcomes. Maintain comprehensive records of all REMS-related activities and decisions.
Qualification
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Required
Bachelor’s degree in Business Administration, Life Sciences, Pharmacy, or a related field.
Minimum of 3-5 years of experience in business analysis, preferably within the pharmaceutical or healthcare industry.
Experience with REMS programs or regulatory compliance is highly desirable.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Proficiency in business analysis tools and techniques.
Knowledge of FDA regulations and REMS requirements.
Ability to work collaboratively in a cross-functional team environment.
Detail-oriented with strong organizational skills.
Preferred
Advanced degree (MBA, MPH) is a plus.
Company
Simpliigence
Simpliigence is an IT consulting company that offers marketing cloud, rpa, CRM, and advisory services.
51-200 employees
H1B Sponsorship
Simpliigence has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (14)
2022 (4)
Funding
Current Stage
Growth StageLeadership Team
Raghu Seetharam
CEO and President
Vivin Deshpande
Consulting Architect & Co-Founder
Company data provided by crunchbase
