About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing on areas of greatest potential and developing solutions for patient need, often in rare or under‑served disease areas and in life‑threatening or life‑limiting conditions. We work directly with patients, doctors, and health‑care professionals on the front line to ensure patient and clinical needs guide our development activities. Our global vision for Patient Centricity supports the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword – it’s a guiding principle for action. We believe all staff have a role to play in creating a patient‑centric culture and integrating an awareness of the patient into everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies, delivering the latest insights and real‑world evidence to inform the best decisions for patients and their caregivers, ensuring the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity

As a Specialist, R&D Digital Product Management and Business Analysis, you will be responsible for participating in the implementation and ongoing support of our existing products and projects, driving business and technical requirements and delivery. You will also participate in cross‑functional collaboration to define maintenance, upgrades, integrations, releases, and decommissioning for assigned clinical and/or operational systems.

Hybrid Working

At Astellas we recognize the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimizing the most productive work environment for you to succeed and deliver.

Key Activities for This Role

• Participate in the strategic assessment of continual improvement of information and systems incorporating innovation and industry best practices and vendor strategy for strategy development, roadmaps and planning.
• Manage the user acceptance test process to ensure business requirements are appropriately tested and risks identified and mitigated.
• Manage issues, escalations, and the process for documentation and resolution of issues through triaging mechanisms.
• Actively participate in SLC process including writing requirements, validation plans, testing plans and scripts.
• Partner with appropriate Digital, Quality and M&D functions to manage documentation and test strategies related to implementation of system enhancements.
• Be an active member of the team collaborating with key stakeholders and functions, and relevant external stakeholders, including system vendors.

Essential Knowledge & Experience

• Experience in the pharmaceutical industry and/or management consulting group focused on R&D or Clinical Operations, with experience in a drug development setting.
• Knowledge of the global drug development process to ensure cross‑functional connections and operational data model are appropriately and effectively communicated across the organization.
• Excellent oral and written communication and presentation skills.
• Experience working cross‑functionally and cross‑culturally in support of business processes and/or systems, especially as they impact and influence multiple departments.
• Experience in the SLC processes, specifically, documenting requirements, validation and testing plans.
• Demonstrated ability to prioritize tasks efficiently.

Preferred Knowledge & Experience

• Understanding of Clinical Information systems and vendors.
• Previous experience in the development, deployment, and/or maintenance of Clinical Information systems.
• Experience in Agile Development, Product Management, and Software Development Life Cycles including requirements/specifications development and user acceptance testing for computer systems in a GxP environment.

Education / Qualifications

• Bachelor’s degree in Business Administration, Business Science or Systems Engineering or equivalent.

Additional Information

• This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.