Associate Director, Publishing and Submission Management

Company: Takeda Pharmaceutical
Location: Lincoln
Posted on: November 24, 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 an Associate Director, Publishing and Submission Management where you will provide project and publishing group leadership, and submission oversight in support of Takeda Pharmaceuticals products. - Collaborate with submission teams, to plan and execute timely regulatory submissions, primarily in eCTD/NeeS formats, in support of investigational and marketed products. - Own submission plans to develop, track and report on deliverables for major milestone submissions including initial NDA, BLA, NDS, or MAA. Identify potential risks to submission plans and propose risk mitigation strategies. - Partner with project management and functional areas to develop strategic plans for health authority submissions and interactions. - Liaises with other functional managers to ensure consistency of departmental approach within the company.You will also effectively forecast and manage project specific resources utilizing flexible resourcing, and employing global load sharing as standard business practice. - Recognize the internal and external interdependencies among submission activities that could have an impact to the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality.As part of the Submissions Publishing team, you will report to the Global Head of Submissions Publishing and work with functional areas across the business.How you will contribute:

• Assists in building effective relationships with external publishing vendors/contractors and software providers as appropriate to facilitate effective processing of the regulatory submission workload.
• Provides support in assuring adherence to budgets, schedules, work plans and key performance indicators (KPIs).
• Assists in developing and maintaining operational strategies for improving Publishing systems/ processes for the efficient publishing and archiving of regulatory submissions
• Maintains fluency with regulatory agency submission, publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
• Contributes to decisions making on administrative and operational matters and ensures the publishing team effectively achieves its objectives.
• Maintains an expert, current knowledge of validated systems.
• Represents the company at relevant industry forums and/or software user groups.
• Collaborates with other departments to identify, investigate, and implement new business opportunities.
• When necessary and appropriate, steps in for or lends assistance to direct and indirect reports to help drive results and achieve objectives.
• performance management, corrective action, and compensation administration
• Good leadership skills including changes management, people development, strategic thinking and influencing
• Ability to manage team resources to ensure attainment of department objectives.
• Advanced knowledge of regulatory publishing and electronic document management systems
• Ability to manage multiple customer interfaces and ensuring customer satisfaction
• Effective skills in delivering/ overseeing/ evolving user facing publishing services
• Ability to manage operational responsibilities across disciplines and multiple regions/countriesMinimum 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 10 years of experience in pharmaceutical/biotech industry, with 8 years of hands-on global regulatory submissions management and publishing experience.
  • At least 6 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 projects
  • Understanding of relationship management with demonstrated experience in partnering in large scale situations
  • Business analytics experience and innovative thinking in order to drive insights into operations and change management and support strategic sourcing decisions.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 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: $143,500 - $205,000, 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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