About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support 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 our 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. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure 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 system(s).
Hybrid Working:
At Astellas we recognise 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; optimising 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 the SLC process, including writing requirements, validation plans, testing plans, and scripts
- Partnering with appropriate Digital, Quality, and M&D functions to manage documentation and test strategies related to the implementation of system enhancements.
- Be an active member of the team collaborating with key stakeholders and functions, as well as with 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 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 Poland.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of once per quarter in our Poland office. Flexibility may be required in line with business needs. 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.
#LI-Warsaw
#LI-Hybrid
#LI-EN1