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 Lead, R&D Digital Product Management and Business Analysis, you will be responsible for oversight and management of the strategy associated with multiple products and projects, driving business and technical requirements and delivery. This includes life-cycle activities and system integration processes.
You will also lead the strategic assessment of continual improvement of information and systems incorporating innovation and industry best practices and vendor strategy for Astellas strategy development, roadmaps and planning.
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:
- Leveraging existing drug development knowledge and cross-functional partnerships to anticipate and recommend changes needed to clinical systems, data structure and standards.
- Ensure on-time implementation of assigned products and systems and new releases to end users, within budget constraints and in collaboration with other Digital and M&D functions.
- Oversee the quality review process to ensure changes made in the data model are reflective of and consistent with agreed upon approach and within defined information management governance standards.
- Partnering with appropriate Digital, Quality and M&D functions to manage documentation and test strategies related to implementation of system enhancements.
- Develop and maintain effective collaboration with key stakeholders and functions, as well as of relevant external stakeholders, including system vendors.
- Act as a peer leader within the organization and actively participate to ensure success of the strategic objectives.
Essential Knowledge & Experience:
- Extensive experience in the pharmaceutical industry and/or management consulting group focused on R&D or Clinical Operations, with significant experience in a drug development setting.
- Demonstrated knowledge of the global drug development process to ensure cross-functional connections and operational data model are appropriately and effectively communicated across the organization.
- Experience establishing standards in support of clinical and business operations systems, especially as they impact and influence multiple departments and levels of management.
- Strong and effective strategic thinker and problem solver with high degree of emotional intelligence, with the ability to both recognize and anticipate problems.
- Demonstrated ability to translate solutions into viable action plans at a global level that are effectively disseminated and implemented through cooperation of stakeholders.
Preferred Qualifications:
- Understanding of Clinical Information systems and vendors with an understanding of associated innovation, industry trends and themes.
- 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:
- Bachelor’s degree in business administration, Business Science or Systems Engineering. Master’s degree preferred or equivalent.
Additional information:
- This is a permanent role in Poland.
- Role requires a blend of home and minimum once a 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.
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