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Business Operations Associate

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 Ontario, CA or the UK. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This position will assist in the execution of assigned responsibilities within the relevant Clinical Operations support

function with operational excellence for both early and late stage Clinical Operations

• Support functions in scope for this position may include:

• Clinical Compliance

• Monitoring

• Business Operations includes department performance management, metrics and enhancement,

• departmental communication strategy & management

• Legal Operations - includes Site Budgets, Contracts and Payments

• Vendor Strategy & Management

• Process, Training & Development

• Trial Master File

• Clinical Standards - includes the overall study operational and support model

• Clinical Systems standards and management

May provide input into budgets and timelines related to assigned deliverables

Provide administrative support related to various clinical systems/technology utilized by Clinical Operations

Essential Job Responsibilities:

• Support the day-to-day operations of assigned activities within relevant support function to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives

• Generate and provide accurate and up-to-date project status and financial information (where appropriate)

• within relevant tracking systems/tools

• Proactively identify and escalate issues that arise related to support functional deliverables

• Effectively execute against assigned activities within relevant support function.

• This may include:

• Assist in executing against assigned Clinical Operations Compliance related activities (e.g. completion of effectiveness checks)

• Provide administrative support related to the processing and finalization of clinical study contracts and other related documentation

• Assist CO Vendor oversight/performance team through support of governance meeting preparation, generation of meeting minutes/follow-up actions, generation of key performance measures, completion of vendor related documentation

• Provide administrative support for various clinical systems/technology utilized by Clinical Operations including central processing support (e.g. study invoices) to study teams

• Support meeting preparation materials and documentation of follow-up items in support global study operating model and/or sustainability and optimization of the CRO/Sponsor Partnership for Clinical Operations

• Assist with maintenance training related assignments/curriculum

Quantitative Dimensions:

Responsible for complying with regulations and guidelines and ensuring adherence in support of clinical trial relates support function activities. This position has no direct reports but may provide guidance/oversight to contract staff.

Organizational Context:

Reports to the Business Operations Manager, Clinical Operations or above. This position has no direct reports.

Qualifications Required:

• BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience.

• Must have knowledge of clinical trial conduct

• General knowledge of drug development and ICH/GCP guidelines

• Requires proven project management skills

• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

• Fluent in English.

• Minimal (0-5%) travel required

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

Compensation: $99,800 – 133,000 (NOTE: Final salary could be more or less, commensurate with experience)

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.

#LI-LK

Category Clinical Operational Excellence

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans