Associate Director, RIM Technology Solutions - Hybrid /Remote
Company: Takeda Pharmaceutical
Posted on: January 28, 2023
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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
- 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
- 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
- Bachelor's Degree is required. Scientific or computer-sciences
- 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
- 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
- Experience managing vendors and contracts is strongly
- 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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- 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
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
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.
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.
Massachusetts - Virtual
Keywords: Takeda Pharmaceutical, Newark , Associate Director, RIM Technology Solutions - Hybrid /Remote, IT / Software / Systems , Newark, New Jersey
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