REGULATORY AFFAIRS BUSINESS COORDINATOR, PDT

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.
.
Hourly Wage Range.
$ 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.
.
based e mployee s may be eligible for s hort - t erm incentives.
U.
.
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.
.
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.