This position is for Janssen Japan R&D IT group, taking on mixed roles of Product Analyst and Technical Application Owner. Reporting to Technical Product Owner in Japan R&D IT, Product Analyst will engage with various Janssen R&D business stakeholder in areas such as Drug Safety (Pharmacovigilance and Post-marketing surveillance), Regulatory, Data Science, Clinical Operations.
· Independently troubleshoots more complex problems and suggests effective resolutions.
· Propose/selects tools and methodologies for projects, following compliance and company guidelines.
· With some guidance, balances between IT standards and business need to guide well-informed decisions.
· Applies procedures and processes effectively in compliance with J&J standards.
· With some oversight and guidance, can functions independently and escalates as appropriate.
· Seeks new technologies to proactively improve work processes.
· Works closely with R&D business teams and leads business requirement and process design sessions to help translate business needs into solution specifications.
· Seen by R&D stakeholders as a key IT contact who understands business process, provides inputs for ideation and planning of R&D IT portfolio.
· Forms productive networks with internal and external business partners and the vendor community, and manages expectations proactively by listening, clarifying, and responding effectively to questions and problems.
· Provides oversight to the incident management process from Application Owner perspective.
· Is responsible to maintains business understanding of R&D application landscape and partners with IT support teams, external vendors to achieve the goals as application owner
· Leads and fosters knowledge sharing among the team.
· Is responsible person for daily operations of some of Janssen Japan R&D IT systems.
· Understands of J&J IT’s technology standards and strategies (to be acquired if outside candidate).
· Can analyze requirements and translate them into viable project deliverables, effectively producing requirements documents and functional documents.
· Understands of Application Lifecycle Management and applies compliance requirements within scope of responsibility, provides documentation as necessary and participates in compliance activities as required.
· Analyzes business problems, opportunities, and challenges, factoring in a strong understanding of the technical architecture and the business needs.
The candidate will have opportunity to participate in projects such as:
· Drive project to upgrade current safety database.
· Drive project to migrate to global safety database.
· Plan, analyze and execute projects such as Robotic Process Automation, various AI solutions by collaborating with internal/external teams and vendors.
· Work with R&D clinical teams to implement solutions for secure exchange of clinical trial data.
· Work with global/regional IT teams to understand new technologies implemented within JnJ and implement the same for Japan.
・3+ years of vendor/sub-team management related experience is must.
・Experience of mid-sized IT project execution for a regulated industry is preferred.
・Desirable to have 3+ years of experience in Pharma industry.
・Hands-on experience working as Software Engineer is plus.
＜Skills and Capabilities＞
・Ability of project management
・Ability to effectively communicate with technical and non-technical teams.
・Excellent interpersonal skills and the ability to work in a team environment.
・Ability to operate independently, multi-task, and prioritize tasks appropriately.
• Knowledge of healthcare regulatory environment, PMD Act, Computer System Validation, is a plus.
•Knowledge of healthcare R&D process, with focus on the Drug Development process. Experience in other industries a plus.
• Broad understanding of Design Principles (User Interface and Business Process Mapping) is preferred.
・Demonstrated ability to manage work in accordance with system lifecycle (SDLC) from concept, application development principles to production deployment is required.
・PM certifications are preferred but not mandatory.
・BA/BS degree or equivalent OR 4+ years with advanced degree or equivalent.