Specialist, Business Operations

at Astellas Pharma in Northbrook, Illinois, United States

Job Description

Specialist Business Ops

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 .

The Role

The Specialist Business Ops will provide integrated contract language and strategic advice on complex agreements, and other legal/contract documents, and make independent decisions on the contractual and commercial risks involved, in support of activities for assigned projects, teams,. The SPECIALIST BUSINESS OPS will ensure that the contracts are in compliance with Astellas’ legal and compliance policies. The SPECIALIST BUSINESS OPS will be responsible for developing and the review of contract language for assigned contracts, including but not limited to Health Care Professional (HCP) consulting, confidentiality agreements, vendor and research institution agreements, Investigator Sponsored Research, and Master Services Agreements. This role will facilitate expedient review and resolution of negotiated clauses with parties to help ensure business continuity while remaining compliant and within established guidelines and processes. Interfaces with Legal, Risk Management, Ethics & Compliance and other internal and external stakeholders as required to resolve issues. Contributes to the improvement of the contract process, templates and playbooks by participating in various committees and work streams comprised of members of Astellas.

Responsibilities

Person will be responsible for processing, execution, negotiation, and management of all contracting and outsourcing activities. This includes, Investigator Sponsored Research (ISR) amendments, ISR clinical, non-clinical, non-interventional trial agreements, three-way CDA, work orders and letters of agreement with vendors. May also be required to do consultant agreements, advisory board agreements, publication agreements, amendments to MSAs or other Services Agreements.

1.Contributes to process improvements, managing work flow efficiently, contributing to delivery of the Core Medical Plan

1. Effectively support Medical Affairs deliverables with Project Management / regional Project Managers, CMTs / regional CMTs, MA Finance to drive and ensure timely delivery of MA Objectives and MA Tactics.

2. Collaborates with key stakeholders including Project Management, Therapeutic Area, Clinical Operations, and others to assist with questions, status updates, and upcoming contract needs

1. Contract Review – Provide independent review of legal terms and conditions of various agreements related to Astellas drug development goals. Partners with internal stakeholders to advise as appropriate on a range of contract options and their legal risks based on the group’s objectives in order to realise specific business goals. First line support for Medical and Development functional groups on legal matters as it relates to contracts. Maintains a thorough understanding of Astellas templates and negotiation terms and policies with the ability to draft contract language as needed. Monitors global legal, regulatory and compliance conditions that affect contracts. Contributes to the development of new templates/playbooks, monitors the trends in contract negotiation and legislation changes to create and adopt the alternative contractual terms in coordination with R&D Procurement, stakeholders and Astellas Legal.

1. Collaborates with other medical affairs colleagues in budget planning, forecast review and management in collaboration with M&D finance. Member of working group for quartely budget forecasting for program. Maintain adherence to scope, budget, timelines and risk mitigation plans. Responsible for vendor contracting for relevant tactics, management, and assess performance and adherence to SOPs. Assist in managing invoice activities and financial reconciliation. Follow through on inquires related to invoicing and purchase orders.

1. Collaborates directly with TA Heads; CMT members; E&C; Legal; Finance; Project Management, Clinical Operations, Operational Excellence and other stakeholders necessary to accomplish corporate and department goals.

1. Collaborates cross-functionally, particularly with Finance, Procurement and Legal

1. External parties/vendors, including outsourced providers and HCPs

1. Volume of contracts vary on an annual basis, however, projected volume is estimated at approximately 600+ PO requests / contract requests plus associated requests with values of $40M+.

Required Qualifications

+ Must have a BS or a BA degree in business law or healthcare law or related field

+ Minimum 4 years experience with global contract negotiation, analysis and interpretation required,

+ Experience in pharmaceutical or related industry contracts (investigator or vendor), outsourcing, or clinical development experience

+ Relational understanding of the critical path of drug development process

+ Excellent interpersonal, oral and written communication skills required

+ Demonstrated and proven experience leading individuals and/or teams in the delivery of results.

+ Strong attention to detail

+ Ability to work in a matrix environment

+ Ability to produce quality work under pressure and be able to deliver tasks against tight deadlines

+ Must be able to balance competing project priorities from multiple client groups globally

+ Ability to analyze complex legal issues

+ Ability to quickly acquire knowledge of unfamiliar fields of law in a global setting

+ Computer literacy, including Microsoft Office Suite

+ Must be self-motivated and conscious of both the quality and timeliness of the work completed

+ Good time management, planning and scheduling skills

+ Team player, collaborative, relationship oriented

+ Ability to function autonomously with little supervision

+ Complete fluency reading and writing in the English language

Preferred Qualifications

+ Experience with budget/financial analysis

+ Experience in the drug development field

+ Line management experience

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.

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 401(k) match and annual company contribution

+ Company paid life insurance

+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

+ Long Term Incentive Plan for eligible positions

+ Referral bonus program

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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Category Medical Affairs – USA

Astellas is committed to equality of opportunity in all