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Sr Manager, GCP Inspection Strategy

at Takeda Pharmaceuticals in Montpelier, Vermont, United States

Job Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVES/PURPOSE

+ Project manage and facilitate cross-functional study execution teams’ GCP inspectionreadiness and inspectionexecution activities, including CRO partners

+ Partner cross-functionally with Clinical Quality Assurance (CQA) and Quality Compliance & Systems (QCS) partners to assurealignedapproach to inspectionreadiness strategy actioned to study execution teams

+ Champion inspectionreadinessprocessimprovements and providedirectchange management support for clinical trial delivery projects and initiatives

ACCOUNTABILITIES

+ Provide project management, oversight, and expert GCP guidance to study execution teams in Inspection Readiness including, butnot limited to, completion of Inspection Readiness Checklist, identification & mitigation of inspection risks, storyboard development for high-risk issues, and creation of functionalpresentations in preparation for mock and actualinspection.

+ Manage study execution teams in prioritizinginspectionreadiness deliverables and mitigation of inspection risks

+ Identify and engage appropriate Sponsor and CRO SMEs in the inspectionreadiness activities

+ Activelyparticipate in Strategy Team Meetings and Lead Core Team Meetings for assignedInspection Readiness projects

+ Maintaindocumentationsuchas project management plans/trackers, timelines, and progress reports to track, manage, and report on study execution teams’ inspectionreadiness

+ Duringinspections, managefunctional teams by assigningrequests to appropriate functionalSMEs; providingnecessary follow-up and guidance to ensuretimelyfulfillment; liaising with functionalSMEs and QA to assurealignment; providing regular status updates to appropriate stakeholders and leadership

+ Identify and action areas for improvement in Inspection Readiness process

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

+ Minimum of 6+ years clinical researchexperience in pharmaceutical or biotechnology field

+ Solid knowledge of and experience in regulatoryinspectionreadiness and executionprocesses

+ Experience with CROs and outsourced clinical trial activities

+ Solid knowledge of drugdevelopment and clinical trial processes, includingrelated standards and documents.

+ Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders isrequired

+ Solid knowledge of regulatoryrequirementsgoverning clinical trials and industry best practices

+ Bachelor’s degree preferred or commensurate with experience

+ Must be able to efficientlyutilize computer software programssuchas Microsoft Office for general use, project management and presentations

ADDITIONAL INFORMATION

+ This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

+ Base Salary Range: $130,200 to $186,000 Range . Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

+ The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts – Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

\#LI-Remote

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Job Posting: JC248679571

Posted On: Sep 28, 2023

Updated On: Feb 15, 2024

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