Sr. Business Analyst, NA Application Systems

Location
Emeryville, CA, United States
Posted
Mar 22, 2021
Ref
1039
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 4,000 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA (US HQ), contributes important ophthalmic research & development and commercialization efforts, and is home to our regional business teams. This office currently employs about 140 people with large growth plans. Santen employs over 300 people in North America including our Ontario, Canada office and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

With the passionate support of our Japanese parent company and its 130-year heritage, Santen is pursuing intellectually challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss. We are in search of top talent to help us meet our aggressive and important goals.

PRIMARY PURPOSE OF POSITION:

This position provides strategic business analysis services to our business partners in mainly but not limited to R&D, Quality and Compliance areas of Santen. The focus of this position is to work closely with the business units to gain in-depth understanding of customer's business strategy, processes, services, roadmap and the context in which the business operates. This role will be key to understanding and documenting capabilities needed to address business challenges.

The Senior Business Analyst will review assigned business processes from end-to-end to identify and address operational, financial and technological risks. Identify opportunities to improve efficiency. Responsibilities will include a full range of activities from leading small to mid-size projects to assisting other project managers on larger more complex projects related to operational business functions that affect team members and external vendors.

Responsibilities:
  • This position will assume technical role in administration, maintenance and support of some of the systems that the team will implement. This individual will create technical documentation, system operational procedures including service level agreements, roles and responsibilities for systems.
  • Demonstrate up-to-date expertise in Information Systems and collaborate with vendors and other IT areas such as Infrastructure, Information Security and End-User Support to ensure all appropriate aspects of implementation, maintenance and support of systems are covered.
  • Provide hands-on expertise in IT compliance including 21 CFR Part 11 and Computer Systems Validation (CSV) including training team members on CSV policies/ processes, developing CSV deliverables and partnering with QA to ensure compliance of systems with regulations.
  • Manage customer relationships and expectations by developing a communication process to keep others up-to-date on project results.
  • Stay current with customer needs and strategies; utilizing formal and informal written communication methods (for example, emails, newsletters, PowerPoint presentations, executive updates, task lists, updates) to communicate updates and findings; and facilitating project meetings and presentations to all types of diverse audiences (for example, senior management, technical staff)
  • Lead or participate in multiple projects by completing and updating project documentation; managing project scope; adjusting schedules when necessary; determining daily priorities; ensuring efficient and on-time delivery of project tasks and milestones; following proper escalation paths; and managing customer and supplier relationships
  • Provide leadership to team members and peers by collaborating with others; articulating ideas and viewpoints to senior management, peers and others; identifying and initiating projects; managing resources; driving the resolution of issues; and holding self and team accountable for results
  • Provide project level analysis – producing required project analysis documentation (business requirements, scope matrix, use cases, sequence diagrams, future state proposals, UAT plan)
  • Collaborate closely with developers to implement the requirements, provide necessary guidance to testers during QA process
  • Identify ways to increase adoption and customer satisfaction
  • Demonstrated fluency in business processes and process differentiation

Requirements:
  • Bachelors degree or equivalent experience in Business, Information Technology or related field.
  • 5 or more years of experience in identifying, designing, and implementing systems and 3 or more years of experience as a Business Analyst or Project Manager in biopharmaceutical application system areas.
  • Understanding phases of System Development Life Cycle Validation approach and practical working knowledge of computer system validation requirements.
  • Knowledge of validation of cGMP automation/computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation.
  • Strong business analysis skills and strategic thinker.
  • Excellent interpersonal, organizational, planning, presentation, documentation, facilitation and communication skills.