Manager, Regulatory Submissions Publishing

Company: Takeda Pharmaceutical
Location: Reading
Posted on: March 17, 2023

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 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 About 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 Manager, Regulatory Submissions Publishing where you will support global processes; executing end-to-end submission assembly which includes publishing, quality control verification, finalization, and delivery. This requires collaborative interaction with component providers and submission managers to ensure quality, the right-first-time output, and timeliness. You will assume the role of lead publisher for larger, complex submissions (e.g. original marketing applications), which will include coordination of all publishing-related activities and delegation of activities to other publishers. You will also take the lead in the development of administrative documentation, provide inter-departmental and/or external stakeholder mentoring, and play an integral role in the testing and implementation of new systems, tools, and processes. As part of the Submissions Publishing, you will report to the Global Head Submissions Publishing and work with a variety of stakeholders. How you will contribute:

• Plans and manages detailed publishing timelines; provides reporting on publishing status to key stakeholders.
• Proactively escalates publishing concerns, risks, and issues that may delay/impact the submission and presents risk mitigation for publishing strategy.
• Collaborates with other functional managers to develop strategies to mitigate risks to timelines and other issues.
• Keeps abreast of fluency with regulatory agency submission, publishing, and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
• When necessary and appropriate, steps in for or lends assistance to individual contributor direct reports to help drive results and achieve objectives.
• Work closely with content providers to produce high-quality submission-ready documents that adhere to internal and external electronic submission guidelines.
• Ensure submission documents meet the level of technical integrity required for Takeda publishing tools.
• Provide authors with formatting assistance as needed, as well as guidance with regard to publishing and referencing processes.
• Identify, assess, and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of submissions.
• Assist with departmental metrics by tracking the status of projects, day-to-day production activities, and publishing anomalies.
• Assist with the development of publishing processes and/or documentation as needed, including user acceptance testing for new or updated publishing tools.
• Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders.
• Identify activities and business processes in need of improvement and consider potential solutions or new ways of working using standard procedures. Minimum Requirements/Qualifications:
  • Bachelor of Science Degree in Technical Discipline such as Life Sciences or Health Care Professions (Engineering, Biology, Chemistry, Nursing, Pharmacy) or related discipline; Advanced degree preferred.
  • At least 6 years of experience in the pharmaceutical/biotech industry, with 4 years of hands-on global regulatory submissions management and publishing experience.
  • Fully understands regulatory publishing and electronic document management systems.
  • Master knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
  • Expert working experience with CTA's, INDs, orphan drug applications (ODA), CTD dossiers for MAAs, national submissions, MRP/DCP, and centralized procedures. Including post-marketing submissions such as variations, renewals, labeling, etc.
  • Significant experience in global drug development and in R&D operations or related fields leading a medium to large organization and influencing senior-level management and key stakeholders.
  • Experience with supporting and leading the successful delivery of projects (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change transformation projects. What 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 a company match of charitable contributions
    • Family Planning Support
    • Flexible Work Paths
    • Tuition reimbursement 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.Base Salary Range: $102,200 - $146,000, based on the candidate's 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. 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.This position is currently classified as "remote" 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.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

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