Senior Manager, Publishing and Submission Management

Company: Takeda Pharmaceutical
Location: Bergenfield
Posted on: November 19, 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 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 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 Senior Manager, Publishing and Submission Management 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 regulatory project managers to ensure quality, right first time output and timeliness. The incumbent 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:

• Work closely with regulatory project managers to lead the production of high quality submission assemblies utilizing submission-ready documents that adhere to internal and external electronic submission guidelines
• Ensure submission assemblies meet the level of technical integrity required for Takeda and health authority validation tools
• Assume the lead for training/mentoring internal and external publishing staff
• Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time submission assemblies
• Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions
• Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies.
• Assume the lead role in the development of publishing processes and documentation, including user acceptance testing for new and updated publishing tools. Delegation of these project activities to publishers within the department as needed.
• Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders
• Evaluate activities and business processes, identify areas in need of improvement and take the lead in investigating potential solutions or new ways of workingMinimum Requirements/Qualifications:
  • At least 8 years of experience in pharmaceutical/biotech industry, with 6 years of hands-on global regulatory submissions management and publishing experience.
  • 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 3 years managing individual contributors in addition to the ability to lead by influence and work effectively in matrix organizational structures
  • Master knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
  • Expert working experience of 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 field, leading a medium to large organization and influencing senior-level management and key stakeholders
  • Experience with supporting and leading successful delivery of projects (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change / transformation projectsWhat 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.Base Salary Range: $130,200-$186,000, 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. 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.#RM-LIEEO 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote

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