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Takeda Pharmaceuticals Medical Writing Operations Leader- Remote in Boston, Massachusetts

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

Medical Writing Operations Leader

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Writing Operations Leader, based remotely.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Medical Writing Operations Leader working on the Medical Writing team, you will be empowered to ensure that documents developed within the medical writing department meet the quality standards established for regulatory submissions, including the integrity of content relative to the source information/data, consistency of messaging, and compliance with Takeda submission-ready standards.

POSITION OBJECTIVES:

  • The Medical Writing Operations Leader is responsible for ensuring that documents developed within the medical writing department meet the quality standards established for regulatory submissions, including the integrity of content relative to the source information/data, consistency of messaging, and compliance with Takeda submission-ready standards.

  • The Medical Writing Operations Leader evaluates trends emerging from the quality control findings and recommends process improvements, training, or other measures.

  • The Medical Writing Operations Leader is a people manager and is responsible (in collaboration with the Head of Medical Writing) for budget and resource allocation pertaining to outsourced editing and publishing activities.

POSITION ACCOUNTABILITIES:

  • Oversee the Medical Writing Operations staff, providing day to day direction regarding document issues and timelines; problem solves as needed.

  • Develop clinical document standards and submission ready standards, working cross-functionally; drives evaluation of QC findings and publishing errors to establish areas for improvement or training needs.

  • Lead or participate in departmental or cross-functional initiatives including systems related enhancements; ensures clear strategic vision of the Medical Writing Operations group.

  • Perform management activities including people/performance management, employee development; oversight of external service providers.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor’s degree in basic science, business, or other analytical field

  • 10+ years of related experience in the pharmaceutical industry and/or in a discipline directly related to document production (eg, medical QC, editing, publishing)

  • 5+ years of management experience with proven experience of mentoring/coaching staff and presenting to/training colleagues

  • Excellent project management skills, including a generic understanding of clinical timelines (study and submission level) and understanding of the roles of other functional areas and the interdependencies among groups

  • Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams

  • Ability to oversee the Medical Writing Operations aspects of a budget

  • Ability to oversee contractor staff and partner with external vendors

  • Ability to work cross-functionally contributing to company-wide standards and processes

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

Base Salary Range: $156,800 -$224,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. 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.

No Phone Calls or Recruiters Please.

*KB-LI

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

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