Senior IT R&D Business Analyst
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
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 a Sr. IT R&D Business Analyst who will be responsible for developing relationships with R&D stakeholders, surfacing unmet IT needs and change requests, and managing 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.Key Accountabilities/Core Job Responsibilities:
- Lead requirements gathering efforts and translate Business Requirements into system Functional, non-functional, and operational requirements.
- Identify areas of improvements with a focus on business systems and translate these opportunities into technical solutions.
- Facilitate and manage group requirements review sessions
- Assist in product solution identification, evaluation, selection, implementation, testing, and working with the IT Delivery Team(s) in delivering the business requirements.
- Work closely with Project Managers to develop/review/finalize Statement of Work, Project Objectives. Assume responsibility for project tasks and ensure they are completed in a timely fashion.
- 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.
- Identify and recommend business process improvements and develop system roadmaps.
- 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 and to help the business mature and scale.
- Assist in developing user and system administration procedures.
Qualifications and Requirements:
- 7-10 years minimum experience in the Information Technology field.
- 5+ years of working in Bio-Tech/Bio-Pharmaceutical Industry supporting R&D as a business analyst.
- 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, ).
- 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.
- Experience with SOP authoring relative to R&D processes and 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.
- S elf-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.