IT R&D Business System Analyst II
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
Pharmacyclics is seeking an IT R&D Business System Analyst II who will be responsible for developing relationships with R&D stakeholders, surfacing unmet IT needs and evaluating need for change requests, and managing portfolios of software products and IT projects. The individual will serve as a strategic IT liaison to the R&D organization and will translate their business requirements into technical solutions and processes. The individual will be expected to guide business teams on IT GxP processes, 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 with stakeholders and delivering strategic and meaningful Enterprise level R&D IT solutions.
Key Accountabilities/Core Job Responsibilities:
Lead requirements gathering efforts and translate Business Requirements into Functional/Technical Specifications.
Develop the necessary documentations for IT solutions delivery, working closely with Project Managers (e.g. Statement of Work, Project Objectives, Use Cases, Project Charter, Vendor Service Level Agreement, Stakeholder Requirements, Functional Requirements, Transition Requirements, Training Documents, etc.).
Evaluate and validate IT solutions against R&D needs.
Generate Test Plan, Use Case Scenarios, Test Cases, and conduct User Acceptance Testing with business partners.
Identify and recommend business process improvements.
Assist in product solution identification, evaluation, selection, implementation, testing, and working with the IT Delivery Team(s) in delivering the business requirements.
Provide data stewardship and governance within R&D.
Support and provide guidance to help the business adopt new methodologies and technologies.
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.
Qualifications and Requirements:
7-10 years minimum experience in the Information Technology field.
5+ years of working in Bio-Tech/Pharmaceutical Industry supporting R&D applications as a business analyst.
Strong knowledge of processes and applications related to Clinical Operations, Medical Affairs, Clinical Data Management, Clinical Science, Biostatistics, and Drug Safety & Pharmacovigilance (e.g. Oracle Argus, BioClinica, CTMS, JReview, SAS, etc.).
Knowledge of procedures and best practices related to FDA, EMA, GxP systems, 21 CFR Part 11, Computer System Validation, Sunshine Act, HCP Transparency Reporting, and other regulations governing drug development and commercialization.
Experience with SOP authoring relative to R&D processes and GxP applications.
Ability to articulate complex technical problems and business value to a wide business audience.
Excellent verbal and written communication skills.
Ability to organize and present ideas in a convincing and compelling manner.
Ability to troubleshoot issues and work independently with minimal direction.
Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.
Bachelor's degree in business, computer science or related discipline.