Sr Manager, GCP Inspection StrategyRemote
- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal
At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Office (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.
Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.
At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.
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
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
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
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.
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.
LocationsMassachusetts - Virtual
Time TypeFull time
The heart of our work
Shining a light on new perspectives
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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