Specialist, IT Business Analysis (00037)

Ascendis Pharma • No location specified • Full-time

$194,792

per year

Regulatory Compliance Data Management Pharmaceutical Clinical Systems IT Business Analyst

Job Description

Duties: Identify, analyze, and document end-to-end business processes. Perform system gap analysis and implement IT system improvements to simplify and optimize clinical system processes. Collaborate with the Clinical Data Management team to scope out business requirements and implement IT solutions. Work closely with stakeholders to understand emerging business needs and current business processes and translate them into functional & non-functional requirements. Assist with validation activities related to system implementations. Facilitate workshops and translate user needs into user requirements and use cases for IT systems. Create deliverables in IT projects such as vendor research, workflow procedures, data modeling, process gap analysis, risk assessments, and solution design. Act as change manager in IT projects, manage stakeholders and effective communication. Maintain an up-to-date knowledge of technological opportunities and understand how technology can transform business processes. Maintain an up-to-date knowledge of regulatory and reporting requirements. Veeva Platform Associate Administrator Certification is required.

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ABOUT ASCENDIS PHARMA, INC.

Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany, Princeton, New Jersey, Redwood City, and Palo Alto, California.

Ascendis is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action-Employer, making decisions without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, marital status, protected veteran status or any other protected class.

JOB TYPE: Regular

PRIMARY LOCATION: Palo Alto, CA

ORGANIZATION: Ascendis Pharma Inc.

SCHEDULE: Full-time

SHIFT: Day

TRAVEL: Telecommuting is allowed from within the Palo Alto, CA, area two (2) days a week

Minimum requirements: Master’s or Bachelor’s degree (U.S. or foreign equivalent) in Computer Science, Information Technology, or a related field and three (3) years of experience (with Master’s) or five (5) years of progressively responsible post-baccalaureate experience (with Bachelor’s) in a related IT business analysis role in the pharmaceutical or biotechnology industry. Prior experience must include three (3) years (with Master’s) or five (5) years (with Bachelor’s) in/with: the entire IT business systems analysis lifecycle, including feasibility analysis, requirements analysis, system risk analysis, and solution design, usability testing, defect tracking, and issue solution; collaborating with cross-functional stakeholders on systems analysis and issue resolution; IT system feature development and enhancement; quality assurance testing to detect and resolve software defects; demonstrated experience with eTMF, CDMS Vault, IRT, CTMS, EDC, Spotfire, R/R-Shiny, or Power BI; regulatory requirements and configuration in pharmaceutical development and manufacturing fields using current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, and Compliant GxP Computerized Systems (GAMP5) and SOX. Prior experience must include two (2) years of prior experience in/with: using SQL to extract, transform and load (ETL) data. Veeva Platform Associate Administrator Certification is required. Telecommuting is allowed from within the Palo Alto, CA, area two (2) days a week. Salary: $194,792/year, M-F, 40 hours/week.