Associate Director, RIM Technology Solutions - Hybrid /Remote
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 24, 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 an Associate Director, RIM Technology
Solutions 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. Represent the
business needs related to technology, systems and Regulatory
Information Management on GRA initiatives, to ensure the teams meet
their goals and objectives, e.g. IDMP, SPOR, MDM, and SPL. You will
also Works 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, e.g. 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 8 years of experience in Pharmaceutical industry, with
6 years in Regulatory Affairs, research and development,
Information Technology or quality assurance/compliance.
- 3 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, i.e. FDA and EU
regulations, and ICH guidelines. Must have experience with
industrial interpretation with respect to regulatory
- expectations.
- 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:
$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. 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 "hybrid" or
"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
Keywords: Takeda Pharmaceutical, Cherry Hill , Associate Director, RIM Technology Solutions - Hybrid /Remote, Executive , Cherry Hill, New Jersey
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