Manager, Regulatory Submissions Publishing
Company: Careerbuilder-US
Location: Bartonsville
Posted on: January 24, 2023
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Job Description:
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application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takedas 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 Manager, Regulatory Submissions Publishing where
you will support global processes; executing end-to-end submission
assembly which includes publishing, quality control verification,
finalization and delivery. This requires collaborative interaction
with component providers and submission managers to ensure quality,
right first time output and timeliness. You will assume the role of
lead publisher for larger, complex submissions (e.g. original
marketing applications), which will include coordination of all
publishing-related activities and delegation of activities to other
publishers.
You will also take the lead in the development of administrative
documentation, provide inter-departmental and/or external
stakeholder mentoring, and play an integral role in the testing and
implementation of new systems, tools, and processes. As part of the
Submissions Publishing, you will report to the Global Head
Submissions Publishing and work with a variety of stakeholders.
How you will contribute:
Plans and manages detailed publishing timelines; provides reporting
on publishing status to key stakeholders.
Proactively escalates publishing concerns, risks and issues that
may delay/impact the submission and presents risk mitigation for
publishing strategy.
Collaborates with other functional managers to develop strategies
to mitigate risks to timelines and other issues
Keeps abreast of fluency with regulatory agency submission,
publishing and validation standards to ensure compliant, valid
dossiers in core regions and emerging markets.
When necessary and appropriate, steps in for or lends assistance to
individual contributor direct reports to help drive results and
achieve objectives.
Work closely with content providers to produce high quality
submission-ready documents that adhere to internal and external
electronic submission guidelines
Ensure submission documents meet the level of technical integrity
required for Takeda publishing tools
Provide authors with formatting assistance as needed, as well as
guidance with regards to publishing and referencing processes
Identify, assess and actively resolve or escalate where necessary
any risks or issues that could impact the successful completion of
submissions
Assist with departmental metrics by tracking status of projects,
day-to-day production activities, and publishing anomalies
Assist with the development of publishing processes and/or
documentation as needed, including user acceptance testing for new
or updated publishing tools
Assume the role of subject matter expert for specific functions or
processes, interacting and mentoring both within the department and
with external stakeholders
Identify activities and business processes in need of improvement
and consider potential solutions or new ways of working using
standard procedures
Minimum 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 6 years of experience in pharmaceutical/biotech industry,
with 4 years of hands-on global regulatory submissions management
and publishing experience.
Fully understands regulatory publishing and electronic document
management systems
Master knowledge of regulatory procedures and a wider understanding
of patient safety and commercial registration status.
Expert working experience of CTAs, 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
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: $102,200 $146,000, 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-LI
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 #LI-Remote
Keywords: Careerbuilder-US, Bethlehem , Manager, Regulatory Submissions Publishing, Executive , Bartonsville, Pennsylvania
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