Sr. Business Analyst - R&D and QC Systems - United States
PRIMARY PURPOSE OF POSITION:
Santen is becoming a global pharmaceutical company with harmonized processes and applications. This position brings critical values in bridging R&D and Quality Compliance business functions and technology resources, and supports business needs in Pre-Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovilligence, Clinical Operations, Data Science, and Quality Assurance. Sr. Business Analyst understands existing processes and advises business to improve processes and IT solutions based on broad business/technology knowledge. This position supports management of vendor relationship, contracts, SLA’s and troubleshooting. In order to maintain a lean applications portfolio, this position will work closely with global business/IT resources to maintain global inventory of applications. The position reports to Associate Director, R&D and Quality Compliance systems.
MAJOR DUTIES OF POSITION:
- Provide Subject Matter Expert level guidance on functionality of biotech/pharmaceutical R&D and Quality Compliance systems and processes.
- Act as technical liaison between related departments, business partners, vendors and other members within the IT group, in particular when implementing and troubleshooting systems.
- Proactively identify/analyze business process and system improvement opportunities as well as opportunities to leverage existing systems to create strategic business advantage
- Manage existing R&D and Quality Compliance applications in alignment with business strategic goals of the organization
- Finalize applications inventory and identify opportunities to harmonize applications to develop an efficient systems landscape. Maintain process maps, entity relationship diagrams, data dependency diagrams and applications relationship maps.
- Responsible for technology vendor relationship management in the areas of maintenance, support, contract renewal, SLA’s tracking and problem solving.
- Author key documents, including Requirements, Process Flows, Use Cases, Test Scripts, User Manuals and Training materials, and various other technical documents.
- Support system development standards and service management standards including change management, incident management and internal SLA’s.
- Design solutions and implement applications in compliance with Computer System Validation (CSV), HIPAA and 21 CFR Part 11.
- Provide regulatory compliance expertise, guide project teams and contribute to CSV and Quality System activities (Change Management, Risk Management, Risked-based approach to CSV, Validation Plan and Report, Validation Report, Deviation, Root Cause Analysis, CAPA).
- BS in Information Systems, Computer Science, Math, Engineering or Scientific discipline, MBA a plus.
- 8 or more years experience in identifying, designing, and implementing system needs in biotech/pharmaceutical R&D and Quality Compliance domains.
- Strong business analysis skills and strategic thinker. Experience in BPM and BPR.
- Expert knowledge and hands-on experience with CSV.
- Experience in designing, implementing, and managing Electronic Document Management System (EDMS).
- Experience in managing IT Partners and off-shore implementation companies.
- Experience in following development and service management standards; ITIL a plus.
- Experience in data integration and master data management is a plus.
- Prior experience with enterprise data warehouse models, BI and reporting is a plus.
- Prior experience in managing applications landscape at biotech/pharmaceutical companies is a plus.
- Excellent interpersonal, organizational, planning, presentation, documentation, facilitation and communication skills.
List working relationships inside/outside of the organization other than your Direct Manager:
- Pre-Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovilligence, Clinical Operations, Data Science, and Quality Assurance departments of Santen Inc. (from department head to staff level).
- Other members of Santen IT organization, locally and globally.
- Various IT vendors providing products, solutions and/or services.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to:
- Spend considerable time at computer
- Move computers and computer-related equipment
- Stand, kneel and stoop for filing
- Use the telephone and speak with external individuals
- Lift 40lbs
- The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.