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Sr Manager, GCP Inspection Strategy

Remote
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  • 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.

Job ID R0107162 Date posted 09/26/2023 Location Remote

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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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Where you fit in

As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.

We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.

Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.

  • Advance clinical research

  • Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity

  • Enable end-to-end management of clinical supply

  • Ensure safety management and inspection readiness

One of the main reasons I came to Takeda is because of the people I would be working for.We all use PTRB as our North Star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.

Marisa Rackley - Head, Clinical Site Startup & Engagement, Global Development Office

It’s leveraging technology, it’s leveraging data in a very different way. It’s not just about using the data that we generate, but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.

Penny Carlson - Head of Innovation and Data, Global Development Office

The culture at Takeda is very unique. It’s a culture that’s extremely collaborative in nature, requiring people from diverse backgrounds to come together, speak up, and really think about the most important thing we need to do for our patients.

Saurabh Awasthi - Executive Director, Trial Insights & Performance Optimization, Global Development Office

The heart of our work

Shining a light on new perspectives

Our pipeline

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.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through 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

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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