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Business Operations Specialist
2 months ago
Business Operations Specialist
Are you eager to join a diverse team dedicated to creating groundbreaking therapies for patients? At Astellas, we are committed to innovating and delivering effective new medicines to healthcare providers and patients alike.
Astellas Pharma Inc. operates in over 70 countries globally, focusing on transforming innovative science into medical solutions that provide value and hope to patients and their families. Our commitment to addressing unmet medical needs while conducting business with integrity and ethics allows us to enhance global health. For more information about Astellas, please visit our website.
Position Overview
The Business Operations Specialist will deliver integrated contract language and strategic guidance on intricate agreements and legal documents, making independent assessments of contractual and commercial risks associated with designated projects and teams. This role ensures that all contracts comply with Astellas' legal and compliance standards. The Specialist will be tasked with developing and reviewing contract language for various agreements, including but not limited to Health Care Professional (HCP) consulting, confidentiality agreements, vendor contracts, Investigator Sponsored Research, and Master Services Agreements. This position will facilitate the prompt review and resolution of negotiated clauses to ensure business continuity while adhering to established guidelines and processes. The Specialist will collaborate with Legal, Risk Management, Ethics & Compliance, and other internal and external stakeholders as necessary to address issues. Participation in committees and work streams aimed at enhancing the contract process, templates, and playbooks is also expected.
Key Responsibilities
The individual will oversee the processing, execution, negotiation, and management of all contracting and outsourcing activities. This includes amendments for Investigator Sponsored Research (ISR), clinical and non-clinical trial agreements, three-way confidentiality agreements, work orders, and vendor agreements. Additional responsibilities may involve consultant agreements, advisory board agreements, publication agreements, and amendments to Master Services Agreements or other service contracts.
- Drive process improvements and manage workflow efficiently to support the delivery of the Core Medical Plan.
- Provide effective support for Medical Affairs deliverables in collaboration with Project Management, regional Project Managers, and Medical Affairs Finance to ensure timely achievement of objectives.
- Conduct independent reviews of legal terms and conditions in various agreements related to Astellas' drug development initiatives. Collaborate with internal stakeholders to provide advice on contract options and associated legal risks to meet specific business goals.
- Assist in budget planning and financial management in collaboration with Medical Affairs and Development finance teams. Ensure adherence to scope, budget, timelines, and risk mitigation strategies.
- Engage with Therapeutic Area Heads, CMT members, Ethics & Compliance, Legal, Finance, and other stakeholders to achieve corporate and departmental objectives.
- Work cross-functionally with Finance, Procurement, and Legal teams.
- Manage relationships with external parties, including vendors and HCPs.
- Handle a significant volume of contracts, with an estimated annual projection of over 600 purchase order and contract requests, totaling more than $40 million.