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Senior Manager, GRA CMC Submission Management

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: November 25, 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 Description Takeda Pharmaceutical 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. How you will contribute: The Senior Manager of GRA CMC Submission Management (CSM) R&D leads the Global CMC Submissions Team for Development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Post- Approval Changes in all countries for the Research and Development Division. The Senior Manager establishes the document plan, prioritizes deliverables, and organizes subject matter experts in Pharmaceutical Sciences, Quality, and other cross-functional stakeholders. The Senior Manager establishes the document plan, negotiates timelines with authors, drives all deliverables against the timeline, compiles all submission ready documents, and delivers the final submission components to the Publishing team. Where R&D deliverables are needed for commercial/GMS regulatory submissions, the Senior Manager collaborates with the CSM Lead in Global Manufacturing and Supply (GSM) to prioritize documents, drive the timeline and manage the R&D stakeholders. The Senior Manager ensures all deliverables are prioritized, tracked and delivered on time, escalates issues where they are identified, and provides strategic insight on issue resolution.In addition, the Senior Manager is responsible for training new hires on the responsibilities of submission management as well as all related processes. The Senior Manager will mentor junior personnel on the strategic aspects of submission team and timeline management, issue resolution and cross-functional collaboration. The Senior Manager will also provide forecasting for product deliverables. Accountabilities:

  • Leadership Responsibilities
    • Trains junior personnel on the global CMC regulatory submission requirements for Takeda drug products (ie, small molecules, biologics, combination products and devices).
    • Trains junior personnel on the global requirements for multiple submission formats (ie, eCTD for IND, IMPD, NDA, MAAs and NEES).
    • Provides input to assist the planning and tracking for global CMC submission activities.
    • Maintains global module 3 templates.
    • Training and Mentoring
      • Mentoring of staff on business process and tools utilized for regulatory submissions.
      • Technical
        • Demonstrated skill in using the Takeda EDMS system(s) and other regulatory tools.
        • Provides strategic insight on eCTD technical requirements.
        • Maintain doc plan and timeline
          • Receive TOC aligned with Reg-CMC strategy
          • Collaborate with Reg-CMC and Content owners to prioritize and align deliverables
          • Establish document structure
            • Create vdoc and applicable templates
            • Author management
              • Lead meetings for kickoff, roundtables, content/data reconciliation, and follow-ups
              • Lead RTQ process (eg, Rapid Response Team)
              • Maintain content verification/approval workflow
              • Train users on submission tools and systems
              • Document management
                • QC, formatting, uploading, filing history, headers/footers, linking, and folder/vdocstructure
                • Document legalization, as needed
                • Provide risk analysis and develop mitigation planning
                  • Identify and prioritize submission issues
                  • Resolve issues; escalate where needed
                  • Drive submission readiness
                    • Content verification and final quality check
                    • Finalize deliverables for completion of submission
                      • Transfer TOCs
                      • Provide submission ready docs to publishing
                      • Archive necessary documents Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.6+ years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (eg Pharmaceutical Development, Analytical Development, Production, Quality Assurance).Knowledge of global regulatory guidelines and experience in regulatory submissions (CMC Module 3 information and QOS documents) is essentialUnderstanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.Able to deal with issues of critical importance with minimal supervision. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.Exercises good judgement in elevating and communicating actual or potential issues to line management.Excellent written and oral communication skills required. 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 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.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $124,600- $178,000 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 posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq 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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Clifton , Senior Manager, GRA CMC Submission Management, Executive , Clifton, New Jersey

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