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Business Coordinator, Regulatory Affairs

Boston, Massachusetts
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As a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda’s Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining therapies.

With an 80-year legacy of developing treatments for rare and complex chronic diseases, we thrive on innovation, offering a broad, differentiated portfolio of more than 20 plasma medicines with integrated care solutions to patients in more than 80 countries.

Powered by ~ 17,000 Takeda employees, our ~230 high-quality BioLife donation centers, a dedicated R&D team, and eight world-class plasma manufacturing facilities, we are unleashing data, digital and technology to transform our end-to-end operations and set new industry standards.

This enables us to innovatively and sustainably meet the growing and changing needs of patients, our people, and our planet, today and in the future.

Job ID R0138853 Date posted 11/19/2024 Location Boston, Massachusetts

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Job Description

About the role:

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases.

Join Takeda as an experienced Business Coordinator where you will provide high-level comprehensive administrative support for the Plasma-derived Therapies Business Unit Head of Regulatory Affairs and Head of Plasma, CMC and Device.

You will also manage the scheduling of internal and external meetings, coordinating travel arrangements, preparing reports, budgets, and managing dashboards. As part of the Regulatory team in PDT, you will report to our Head of Regulatory Affairs, and manage special projects, events and operational matters as assigned by our leadership team.

How you will contribute:

  • Provides comprehensive administrative support to the Head of Regulatory Affairs and the Head of Plasma, CMC and Device.

  • Provides project support to the PDT Regulatory Function.

  • Manages the Head of Regulatory and Head of CMC calendars, schedules appointments, and coordinates meetings, ensuring all necessary resources are prepared in advance. 

  • Understands priority meetings; schedules last-minute meetings when necessary. 

  • Organizes face-to-face, virtual and hybrid meetings. 

  • Is aware of meeting locations and travel time between virtual and in-office locations. 

  • Includes pre-reads and proper meeting materials in the invites. 

  • Assists in the preparation and coordination of materials for the department meetings, and other R&D related Massachusetts events. 

  • Facilitates leadership team meetings; ensures timely distribution of agenda; takes meeting notes; tracks action items.

  • Prepares reports, presentations, dashboards, and other documents as requested by the leadership team. 

  • Arranges travel; completes expense reports in a timely manner.

  • Manages specialty documents and correspondence with necessary confidentiality, including letters, reports, emails, presentations, memos, etc.

  • Reviews documents and proofreads work for grammar and spelling, accuracy, consistency of terms, and completeness; ensures document text and graphics adhere to corporate and organization guidelines and standards.

  • Uses appropriate tools for required work including Microsoft Outlook, Word, Excel, Teams, and PowerPoint to track, analyze, document, and report data.

  • Interfaces and communicates with internal and external stakeholders; directs people to the appropriate resources.

  • Researches solutions and responds to email and phone inquiries with minimal input from direct supervisor; interacts effectively with all levels of employees throughout the company; ensures that communications are timely, clear and professional.

  • Collaborates with Procurement team to prepare documentation for payment of vendors, consultants, and suppliers; submits documentation and enters request for payments into accounting system; approves transactions; responds to inquiries from accounts payable and payees.

  • Collaborates with Finance team to track and update budget reports and forecasts.

  • Initiates, develops, leads, and participates in improvement processes; actively participates in resulting process improvements.

  • In collaboration with other administrative partners and business coordinators, organize internal engagement events and support the planning and implementation of leadership engagements across the organization.

  • Provide administrative support to employee workstreams, including in relation to Career Development, Work Processes, and Wellness

  • Understands the structure of the organization and develop a strong network across departments; draw on network to answer questions, solve problems, and successfully execute responsibilities. 

  • Makes decisions with general management direction.  While making decisions, exercise greater latitude based on extensive administrative experience and knowledge of Takeda’s operations, policies, and procedures. 

  • Effectively prioritizes, balances, and manages a variety of projects with differing deadlines to successful completion for the Head of Regulatory and leadership team. 

  • Demonstrates confidentiality in execution of all responsibilities.

  • Performs other duties as required.

Minimum Requirements/Qualifications:

  • High school diploma/GED required.  Associates degree or bachelor’s degree preferred. 

  • Minimum 8 years of relevant work experience, or equivalent combination of training and experience.  Some industry experience is preferred.  

  • Strong PC literacy with advanced skills in Microsoft Outlook, Word, Excel, PowerPoint. Comfortable working with web-based applications such as Microsoft SharePoint, Lists, and Planner. 

  • Excellent verbal and written communication skills.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Hourly Wage Range:

$26.92 - $42.31

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No
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Success profile

What makes a successful team member within PDT at Takeda?

  • Bold thinker
  • Systematic
  • Innovative
  • Collaborator
  • Agile
  • Tenacious
At the iHUB, we focus on disruptive innovation within our patient ecosystem that not only focuses on the patients of today, but creates the pathway to meet the patients of tomorrow.

Nat Arlander - Head of the Plasma Innovation Hub in PDT

Our dedicated and specialized PDT R&D organization is uniquely positioned to support the entire patient experience. By challenging decades of established thinking and driving patient-centric innovations, we have the opportunity to have a tremendous impact on those who rely on plasma-derived therapies today and those who can benefit from them in the future.

Kristina Allikmets - Head of PDT, R&D

Our Los Angeles facility

Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19.

Changing lives with plasma-derived therapies

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 17 companies to receive Top Global Employer® status for 2024.
  • 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.

Exterior of Takeda Building

About our location

Boston, Massachusetts


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