Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Bengaluru and will require some on-site work.
Purpose and Scope:
Responsible for execution of work within the Global Site Payment support function in support of both early and late-stage Clinical Operations
This position supports site payment related activities and will report on performance timelines
This position is accountable for the timely delivery of clinical site payments according to the site contract timelines
Essential Job Responsibilities:
Responsible for the effective management of site payments to investigative sites within the Veeva Site Payment system
Manage and support the day to day operations of site payment processing per established contractual agreements and objectives in compliance with applicable GCP / ICH guidelines and other JSOX / FAR requirements
Provide regular updates of payment status to Clinical Study teams and leadership
Data entry support into Veeva Site Payment system or CTMS system
Site Payment related activities, as required, including the supplier onboarding activities, mailbox management, invoice review and upload, invoice approval against CTMS and EDC (other source data as required), and invoice confirmation for payment
Support investigator payments from invoice receipt through payment including monitoring of status throughout the process to ensure compliance with contract timelines
Manage pro-forma invoice payments as needed
Support of advance payment and suitability / pre-payments
Collaborate with cross functional stakeholders as process requires, including feasibility, study start up, contracts, budget and study team members
Work to proactively identify and resolve payment issues that arise throughout the life of the study (study start up, conduct and close out) including support and oversight of site payment escalations
Oversee site payment systems, standards and processes to ensure timely payment of the investigative sites (either via our vendors or internal payment via Veeva)
Support of input into site payment metrics for functional area, including but not limited to the input, measurement and monitoring.
Bachelor’s Degree or equivalent relevant experience
At least 3 to 5 years prior experience handling and executing on functional specific material (e.g. site payments or related payment material) matters with at least 5 years directly involved with a company within the pharmaceutical/ biotechnology industry. Global experience preferred.
Good understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates.
Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice.
Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner.
Must have a strong knowledge of clinical development processes and ICH/GCP
Experience in a Manager or equivalent role with responsibility and demonstrated success in execution of strategies for relevant non-project support functions.
Must have excellent interpersonal, written, verbal, and computer skills.
Minimal (10-20%) travel required
Fluent in English
Preferred Qualifications:
- Experience working in a Global environment
Working Environment
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Category PlatformX
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans