Senior Business Analyst - GxP
Cambridge, Ohio, United States of America
Contract
20 hours ago
Key skills
Agile
About this role
Accountabilities:
• The Senior Business Analyst is responsible for planning, business requirement/user story development for reports/visualization needs in support of our DevTech Products
• Author and refine system support processes, flow diagrams, configurations, and interdependencies
• Experience with clinical operations and PV
• Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.
• Effectively translates business requirements into user stories and supporting documents like detailed requirement specifications for the agile development team
• Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure
• Highlight potential risks and act proactively to resolve issues
• Follow company and departmental policies, procedures and ensure documentation according to the Takeda Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards.
• Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability.
• Establish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processes.
• Build and maintain relationships with key business stakeholders
Functional Requirements:
• Bachelor''s degree or equivalent in a science discipline or related field
• 7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions
• Knowledge of clinical data management activities and processes, data review and visualization tools
GxP/Pharma Experience: Required
Project Methodology: Agile & Waterfall Please apply with your interest. You may also reach out to me at
Thank you,
Ashu
We provide a comprehensive package which includes.
Benefits
• The Senior Business Analyst is responsible for planning, business requirement/user story development for reports/visualization needs in support of our DevTech Products
• Author and refine system support processes, flow diagrams, configurations, and interdependencies
• Experience with clinical operations and PV
• Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.
• Effectively translates business requirements into user stories and supporting documents like detailed requirement specifications for the agile development team
• Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure
• Highlight potential risks and act proactively to resolve issues
• Follow company and departmental policies, procedures and ensure documentation according to the Takeda Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards.
• Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability.
• Establish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processes.
• Build and maintain relationships with key business stakeholders
Functional Requirements:
• Bachelor''s degree or equivalent in a science discipline or related field
• 7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions
• Knowledge of clinical data management activities and processes, data review and visualization tools
GxP/Pharma Experience: Required
Project Methodology: Agile & Waterfall Please apply with your interest. You may also reach out to me at
Thank you,
Ashu
We provide a comprehensive package which includes.
Benefits
- Medical for full time employees
- Dental, and Vision Insurance
- Life Insurance, Short-Term Disability, Long-Term Disability, etc.