CONTEXT & INITIATIVE DESCRIPTION
Our Fortune 500 Biopharma client is seeking an IT R&D Business Analyst to develop relationships with R&D stakeholders, surface unmet IT needs and change requests, and manage portfolios of GxP systems and R&D IT projects. The individual will serve as a strategic IT liaison to the R&D organization and will translate their requirements into technical solutions and processes. The individual will be expected to actively gather requirements and communicate with Business Partners to assure their understanding of existing tools, projects, and future directions will meet their business needs. The individual will focus on building strong partnerships and delivering strategic and meaningful Enterprise level R&D IT solutions. The position will capture business problem statements and map business processes to evaluate the solution.
DUTIES/EXPECTATIONS OF THIS ROLE
- Lead requirements gathering efforts and translate Business Requirements into system Functional, non-functional, and operational requirements. Facilitate and manage group requirements review sessions
- Identify areas of improvements with a focus on business systems and translate these opportunities into technical solutions. Identify and recommend business process improvements and develop system roadmaps.
- Assist in product solution identification, evaluation, selection, implementation, testing, and working with the IT Delivery Team(s) in delivering the business requirements.
- Develop the technical documentations for IT solutions delivery, such as Stakeholder Requirements, Functional Requirements, Process documentation, Transition Requirements, Training Documents, Testing, etc..
- Generate Test Plan, Use Case Scenarios, Test Cases, and conduct User Acceptance Testing with business partners, perform System Overview and Risk Assessment.
- Interface with business and functional teams providing strong analytical and problem solving skills.
- Work closely with the IT platform leads to apply standards and evolve process to ensure solutions abide by best practices and industry principles and to help the business mature and scale.
MUST HAVES – QUALIFICATION SUMMARY
- 7+ years IT experience
- 5+ years Bio-Tech/Bio-Pharmaceutical Industry supporting R&D as a business analyst. Must have experience interfacing directly with R&D business users.
- Strong Validation/Compliance background: Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, Sunshine Act, HCP Transparency Reporting, and other regulations governing drug development and commercialization.
- Strong knowledge of processes and applications related to Clinical Operations, Medical Affairs, Clinical Data Management, Clinical Science, Biostatistics, Drug Safety & Pharmacovigilance, and R&D (e.g. Oracle Argus, BioClinica, IRMS, CTMS, JReview, SAS, Empower 3, SLIM, Masshunter GCFID/MSD, LC/QTOFMS, TGA, DSC, TIAMO, Veeva Vault eTMF and RIM, MasterControl, ComplianceWire, Axway Activator, SaveAsPDF, OpenLAB ECM, OMNIC, Vaisala, Safely Alert Portal, ).
- Experience with SOP authoring relative to R&D processes and applications.
- Excellent verbal and written communication skills. Must have ability to articulate complex technical problems and business value to a wide business audience.