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 Site Budget Specialist, you will work within the Site Contract & Budget function reporting to the Site Contract & Budget Lead and work closely with members of the Site Contract & Budget function including Site Payment, Ethics & Compliance, and the Clinical Study Teams.
Your position will be responsible for the development, delivery and negotiation of site budgets in line with global standards and regional requirements. The Scope may include local and regional countries. This position is based in Warsaw, Poland.
Hybrid Working:
At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Key Activities For This Role:
- Responsible for the coordination of work within the Site Contract & Budget support function in support of both early and late-stage Clinical Operations.
- Support budget negotiations with clinical investigator sites globally, including appropriate review of escalated budget topics and the implementation of global budget rate cards when applicable.
- Responsible for the support of global best practices as it relates to applying the relevant requirements in the support of clinical trial execution/oversight that adhere to Astellas and GCP/ICH requirements and are developed in close collaboration with Astellas Legal/Ethics & Compliance Organizations.
- Support the efficient delivery of site/investigator clinical contracts and / or budgets, aligned with informed consent language and other general legal language guidelines for clinical site documents that ensure compliance, regional, operational and legal standards, while ensuring contracts and / or budgets are delivered in a timeline and quality manner to meet study/project timelines.
- Responsible for the drafting of the Budget Development Workbook based on review of a study protocol and export of information from GrantPlan.
- Utilize the Agiloft Contract system within Astellas including implementation of a streamlined global process.
- Responsible for the interaction and coordination of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development, along with functions outside of M&D including Astellas Legal, Data Privacy, ICF Standards (and others as required) across the early and late-stage clinical organizations (inclusive of MA and RX+ where applicable).
- Work closely with other members of the Site Contract, Budget & Payment team to ensure a streamlined approach across the department, including Site Payments and ICF Lead(s).
Essential Knowledge & Experience:
- Experience in pharmaceutical related drug development or direct equivalent experience handling contractual / transactional legal matters and / or site budget experience.
- Clinical development processes and ICH/GCP knowledge is essential.
- Demonstrate analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive feedback
- Knowledge of ICH/GCP guidelines and regulatory requirements is essential.
- Fluent in English.
- Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability is highly desirable.
- Minimal (5-10%) travel required.
Preferred Qualification:
- Experience with site budget.
Education:
- BA/BS Degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in Warsaw (Poland).
- 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.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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