Senior Manager, GRO Regulatory Information Management, Hybrid/Remote
Company: Takeda Pharmaceutical
Location: Bronx
Posted on: January 26, 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 a Senior Manager, GRO Regulatory
Information Management where you will be a key contributor
responsible for strategic thinking, and expert execution for the
Information Management portfolio and associated information
repositories serving the Global Regulatory Affairs organization and
business processes. This role will partner with business
stakeholders as well as liaise with Takeda Digital to ensure
activities are implemented to plans with Information integrity and
according to defined requirements and timelines.You will also be
accountable to curate Regulatory information to ensure the highest
quality to meet Health Authority standards and Takeda's strategic
needs. Oversees and ensures appropriate resourcing of global
information management projects; litigation support; M&A;
divestitures, etc.As part of the GRO Regulatory Information
Management team, you will report to the Head, Regulatory
Information Management and Digital Innovation. How you will
contribute:
- Responsible to deliver Regulatory Information Management (RIM)
and associated processes and systems. Ensures information and data
standards are aligned with Takeda's strategic business requirements
(eg MDM, Regulatory strategy, Industry standards, HA
expectations)
- Identifies opportunities for regulatory automation solutions
and may build out business cases for the evaluation and build of
solutions.
- Ensures appropriate enterprise information and solution
integration points for consistent and compliant data flow.
- Partners closely with Digital to ensure fully integrated
regulatory systems, experience, and information model and
externally facing capabilities.
- Ensures there is a strategy and implementation plan for
seamless integration of information and content up and downstream
as well as across the governed regulatory systems portfolio.
- Lead and maintain a collaborative program of continuous
improvement within the regulatory solutions organization.
- Demonstrates a high level of leadership and expert
understanding of global RA information/data set regulations and
guidelines by applying interpersonal skills and expert RA knowledge
to address and overcome challenges that arise
- Successfully communicates and negotiates with international
Health Authorities as necessary, directly or indirectly
- Contributes to day-to-day GRA RIM initiatives (integration,
acquisitions/divestitures, IDMP,xEVMPD, SPOR, MDM).
- Collaborates with other IM leaders to deliver value-add
business-facing services to improve system user experience,
information accuracy, and timeliness
- Engage and lead with external regulatory forums and consortia
on innovation related to solutions and information for the needs of
Global Regulatory Affairs
- Ensures Takeda portfolio support with appropriate SLAs and
customer focus
- Lead and define the development and execution of strategic and
change management initiatives.
- Oversees outsourcing activities performed by the external
vendor(s) for the management of regulatory information including
the development and oversight of robust KPIs and the oversight of
vendor activities for RIM system maintenance. Minimum
Requirements/Qualifications:
- Bachelor's degree or related experience is required. Scientific
or closely related field preferred.
- At least 8 years of experience in Pharmaceutical industry, with
more than 5 years in Regulatory Affairs, research and development,
quality assurance/compliance.
- Significant experience in global drug development regulations,
regulatory submissions, lifecycle management, compliance, business
systems technology and process is required.
- Proven ability to liaise with Regulatory Agencies having served
as lead in Agency Interactions and industry forums, international
experience preferred.
- Expert understanding of scientific principles and regulatory
information standards/requirements relevant to global drug
development and post-market support.
- Understanding in regulatory publishing and Information
management tools is required.
- Proven ability to provide strategic regulatory guidance to drug
development, registration, and post-market support teams.
- 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.
- Exercises good judgement in elevating and communicating actual
or potential issues to line management.
- Active participation in Agency/Industry groups/forums expected.
Recognized as an expert in the field. 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: $
130,200 - $186,000, 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, New Rochelle , Senior Manager, GRO Regulatory Information Management, Hybrid/Remote, Executive , Bronx, New York
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