Strategic Business Operations Expert
2 weeks ago
Business Operations Specialist
Are you eager to join a diverse team dedicated to pioneering innovative therapies for patients? At Astellas, we are committed to developing and delivering groundbreaking and effective medications to enhance the lives of patients and healthcare providers. If you aspire to contribute to this vital mission, we welcome you to be part of our team.
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 our business with ethics and integrity allows us to enhance global health. For more information about Astellas, please visit our website.
Position Overview
The Business Operations Specialist will offer comprehensive contract language and strategic guidance on intricate agreements and other legal documents, making independent assessments of the contractual and commercial risks involved in support of designated projects and teams. This role ensures that all contracts comply with Astellas' legal and compliance standards. The Specialist will be responsible for drafting and reviewing contract language for various agreements, including but not limited to Health Care Professional (HCP) consulting, confidentiality agreements, vendor agreements, Investigator Sponsored Research, and Master Services Agreements. This position will facilitate the prompt review and resolution of negotiated clauses with involved parties 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 resolve issues. Additionally, the Specialist will contribute to enhancing the contract process, templates, and playbooks by participating in various committees and work streams within Astellas.
Key Responsibilities
The individual will manage the processing, execution, negotiation, and oversight 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. Responsibilities may also extend to consultant agreements, advisory board agreements, publication agreements, and amendments to Master Services Agreements or other service contracts.
- Drive process improvements, ensuring efficient workflow and contributing to the delivery of the Core Medical Plan.
- Support Medical Affairs deliverables in collaboration with Project Management, regional Project Managers, and Finance to ensure timely achievement of Medical Affairs objectives and tactics.
- Conduct independent reviews of legal terms and conditions for various agreements aligned with Astellas' drug development goals. Partner with internal stakeholders to provide advice on contract options and associated legal risks to achieve specific business objectives. Serve as the primary support for Medical and Development teams on legal matters related to contracts. Maintain a comprehensive understanding of Astellas templates and negotiation policies, with the ability to draft contract language as required. Monitor global legal, regulatory, and compliance conditions affecting contracts, contributing to the development of new templates and playbooks while adapting to changes in contract negotiation trends and legislation.
- Collaborate with medical affairs colleagues in budget planning, review, and management in conjunction with Finance. Participate in quarterly budget forecasting for programs, ensuring adherence to scope, budget, timelines, and risk mitigation strategies. Oversee vendor contracting for relevant tactics, managing performance and compliance with standard operating procedures. Assist in managing invoicing activities and financial reconciliation, addressing inquiries related to invoicing and purchase orders.
- Engage with Therapeutic Area Heads, CMT members, Ethics & Compliance, Legal, Finance, Project Management, Clinical Operations, and other stakeholders to achieve corporate and departmental objectives.
- Foster cross-functional collaboration, particularly with Finance, Procurement, and Legal teams.
- Manage external parties and vendors, including outsourced providers and HCPs, with an estimated annual volume of approximately 600+ purchase order and contract requests, alongside associated requests valued at over $40 million.
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