Senior Manager, Publishing and Submission Management
Company: Takeda Pharmaceuticals
Location: Hartford
Posted on: January 28, 2023
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAbout 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, Publishing and
Submission Management where you will provide project and publishing
group leadership, and submission oversight in support of Takeda
Pharmaceuticals products. Collaborate with submission teams, to
plan and execute timely regulatory submissions, primarily in
eCTD/NeeS formats, in support of investigational and marketed
products. Own submission plans to develop, track and report on
deliverables for major milestone submissions including initial NDA,
BLA, NDS, or MAA. Identify potential risks to submission plans and
propose risk mitigation strategies. Partner with project management
and functional areas to develop strategic plans for health
authority submissions and interactions. Liaises with other
functional managers to ensure consistency of departmental approach
within the company.You will also effectively forecast and manage
project specific resources utilizing flexible resourcing, and
employing global load sharing as standard business practice.
Recognize the internal and external interdependencies among
submission activities that could have an impact to the schedule or
quality of a submission and manage to ensure that submission goals
are achieved on time and to the highest quality.As part of the
Submissions Publishing team, you will report to the Global Head of
Submissions Publishing and work with functional areas across the
business.How you will contribute:
- Assists in building effective relationships with external
publishing vendors/contractors and software providers as
appropriate to facilitate effective processing of the regulatory
submission workload.
- Provides support in assuring adherence to budgets, schedules,
work plans and key performance indicators (KPIs).
- Assists in developing and maintaining operational strategies
for improving Publishing systems/ processes for the efficient
publishing and archiving of regulatory submissions
- Maintains fluency with regulatory agency submission, publishing
and validation standards to ensure compliant, valid dossiers in
core regions and emerging markets.
- Contributes to decisions making on administrative and
operational matters and ensures the publishing team effectively
achieves its objectives.
- Maintains an expert, current knowledge of validated
systems.
- Represents the company at relevant industry forums and/or
software user groups.
- Collaborates with other departments to identify, investigate,
and implement new business opportunities.
- When necessary and appropriate, steps in for or lends
assistance to direct and indirect reports to help drive results and
achieve objectives.
- performance management, corrective action, and compensation
administration
- Good leadership skills including changes management, people
development, strategic thinking and influencing
- Ability to manage team resources to ensure attainment of
department objectives.
- Advanced knowledge of regulatory publishing and electronic
document management systems
- Ability to manage multiple customer interfaces and ensuring
customer satisfaction
- Effective skills in delivering/ overseeing/ evolving user
facing publishing services
- Ability to manage operational responsibilities across
disciplines and multiple regions/countriesMinimum
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 8 years of experience in pharmaceutical/biotech
industry, with 6 years of hands-on global regulatory submissions
management and publishing experience.
- 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
- Understanding of relationship management with demonstrated
experience in partnering in large scale situations
- Business analytics experience and innovative thinking in order
to drive insights into operations and change management and support
strategic sourcing decisions.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 reimbursementMore 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 "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-LIEEO StatementTakeda 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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
time#LI-Remote
Keywords: Takeda Pharmaceuticals, Hartford , Senior Manager, Publishing and Submission Management, Advertising , Hartford, Connecticut
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