Director, RIM Technology Solutions -Remote

Takeda Pharmaceutical Remote
director rim remote regulatory management information management health r&d spl regulatory submissions regulations patients roadmap
January 24, 2023
Takeda Pharmaceutical
Atlanta, Georgia

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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 Director, RIM Technology Solutions based remotely where you will act as the business owner of Regulatory systems. You will be the regulatory point of contact for the development, implementation, and governance of the GRA systems roadmap. Ensure GRA systems roadmap strategy is aligned with and will effectively support GRA vision/strategy and liaises with external partners to ensure the vision is realized. You will represent the business needs related to technology, systems and Regulatory Information Management on GRA initiatives, to ensure the teams meet their goals and objectives, eg IDMP, SPOR, MDM, and SPL.

You will also work collaboratively with GRA staff and R&D IT to support implementation of technology for regulatory submissions and informatics. As part of the Regulatory Information Management and Digital Innovation team, you will report to the Head, Regulatory Information Management and Digital Innovation and work with a variety of teams and external partners globally.

How you will contribute:

  • Drive and oversee the maintenance and implementation of global regulatory systems and tools for product information, submissions management and other regulatory information to support GRA.

  • Participates in GRA initiatives and represents the business/Takeda needs related to technology, systems and Regulatory Information Management to ensure the teams meet their goals and objectives, eg IDMP; SPL, Registration Tracking.

  • Accountable through vendors and/or a Matrix structure for GRA process optimization

  • Provide input in data migration, update/configuration requirements, integration strategies and change management needs for new and existing systems

  • Examine technology between/within GRA and other functions within R&D to identify opportunities to improve the overall efficiency of Regulatory at Takeda.

  • Establish, updates, implements and provides guidance on Health-authority required formats, templates, policies, standards and procedures where technology and information management for GRA are impacted.

  • Oversee the migration of Regulatory Information as it relates to M&A and Integration activities.

  • Alert Regulatory Operations management where there are deficiencies in technologies and implementation planning and recommends optimization and corrective action plans.

  • Maintain up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, SPL, xEVMPD, IDMP, SPOR, etc.; analyzes new and revised Health Authority Guidance's, advises regulatory management of new requirements and recommends a course of action.

  • Responsible for managing and overseeing vendor(s) in relation to Regulatory systems projects and deliverables.

Minimum Requirements/Qualifications:

  • Bachelor's Degree is required. Scientific or computer-sciences field preferred

  • At least 10 years of experience in Pharmaceutical industry, with 8 years in Regulatory Affairs, research and development, Information Technology or quality assurance/compliance.

  • 5 years of experience in electronic document management technology .

  • Knowledge of the requirements for electronic submissions to regulatory authorities. Experience with regulatory

  • 5 years of submissions and/or information management experience from a technical solutions strategic level, preferably within a corporate environment supporting multi-user systems International experience is strongly desired.

  • Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.

  • Knowledge and experience with industry standards is required. Experience with applying knowledge of information management involving undefined frameworks with medium technical complexity and defined scope. Proven ability to liaise with Regulatory Agencies related to data/systems standards.

  • Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, ie FDA and EU regulations, and ICH guidelines. Must have experience with industrial interpretation with respect to regulatory

  • expectations.

  • Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.

  • Experience managing vendors and contracts is strongly preferred.

  • Project Management qualification is strongly preferred.

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.

Base Salary Range: $160,000-229,000, 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

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 Georgia - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time

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