A leading life sciences organization is currently seeking an IT Business Analyst specializing in Regulatory Affairs, Labeling, and Clinical processes. This role offers the opportunity to work remotely, supporting various clients within the pharmaceutical industry.
About the Opportunity:
- Schedule: Full-time
- Hours: Standard business (40 hours per week)
- Setting: Remote with potential to support multiple clients
Responsibilities:
- Collaborating with cross-functional teams to gather and analyze business requirements.
- Translating complex business needs into functional and non-functional system requirements.
- Developing and maintaining documentation such as BRDs, User Stories, Use Cases, SIPOC diagrams, and process maps.
- Facilitating workshops, interviews, and working sessions to elicit detailed process and system requirements.
- Mapping current-state and future-state processes to identify gaps and improvement opportunities.
Qualifications:
- 5+ years of experience as an IT Business Analyst in the Life Sciences/Pharma industry
- Bachelor’s or Master’s degree in Life Sciences, IT, Business Administration, or related field
- Certifications such as CBAP, PMI-PBA, CSPO, or Lean Six Sigma are a plus
- Deep domain knowledge of Regulatory Affairs, Labeling systems, and Clinical operations
- Experience with regulatory submission processes and clinical trial systems
- Strong skills in requirements gathering, process modeling, and business analysis techniques
- Excellent communication, facilitation, and stakeholder management skills
- Ability to work independently and handle multiple priorities in a dynamic environment
- Solid understanding of SDLC, Agile, and Waterfall methodologies
Desired Skills:
- 5+ years of experience
- Bachelor’s or Master’s degree in relevant fields
- Experience with tools like Veeva Vault, TrackWise, Oracle Argus, Aris, or SAP
- Strong analytical and data mapping skills
- Excellent interpersonal and communication skills
