Regulatory Operations Global Submissions Publishing Lead

Company: Takeda Pharmaceutical
Location: Stevens
Posted on: August 7, 2022

Job Description:

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 Takedas and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Regulatory Operations Global Submissions Publishing Lead where you will formulate and implement submissions publishing vision, strategy, and tactics. You will manage high-performing business partnerships with strategic sourcing vendors focused on submissions publishing. As part of the Global Regulatory Affairs team, you will report to the Head of Regulatory Operations and Cross-Functional Optimization and partner and drive submission publishing process and technology innovation across strategic sourcing and tech partners.How you will contribute:

• Envision and build a lean and fit for Purpose internal publishing capability consisting of FTEs and contractors.
• Influence and partner with global regulators to drive efficiency and innovation into the submissions publishing process.
• Serve as Takeda's submission publish expert internally and externally.
• Identify and implement robotic process automation into the E2E submission publishing process.
• Partner across the company to continuously optimize our submissions publishing process and tools.
• Ensure that Takeda is utilizing robust tools to deliver right-first-time submissions across the E2D submissions publishing process.Minimum Requirements/Qualifications:
  • Bachelor's degree or related experience is required. technical or closely -related field preferred; Advanced degree in information technology or computer science preferred
  • 12+ years of experience in the pharmaceutical/biotechnology industry with direct leadership experience in submissions publishing
  • Senior management experience in R&D operations or related field, leading and influencing senior-level management and key stakeholders
  • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
  • Experience overseeing global and complex business relationships with business partners
  • Direct experience in the pharmaceutical industry or related field required
  • Previous experience leading a medium to large global organization and influencing senior-level management and key stakeholders is a plus
  • Proven track record of leading and driving submissions publishing business process
  • Track record of effective leadership of a diverse set of submissions publishing strategic sourcing and tech vendors
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industryWhat Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • 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 and company match of charitable contributions
    • Family Planning Support
    • Flexible Work Paths
    • Tuition reimbursementMore 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.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#LI-LC1EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeby Jobble

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