Specialist, Business Operations

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

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

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.

• 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.
• Collaborates cross-functionally, particularly with Finance, Procurement and Legal
• External parties / vendors, including outsourced providers and HCPs
• 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+.

Requirements

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.