Senior Manager, GRA, Labeling Compliance
Company: Takeda Pharmaceutical
Location: Lambertville
Posted on: May 14, 2022
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAre you looking for a patient-focused,
innovation-driven company that will inspire you and empower you to
shine? Join us as a Senior Manager, GRA, Labeling Compliance in our
Kendall Square, MA office.At Takeda, we are transforming the
pharmaceutical industry through our R&D-driven market
leadership and being a values-led company. To do this, we empower
our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers,
encourage innovation, and strive for excellence in everything we
do. We foster an inclusive, collaborative workplace, in which our
global teams are united by an unwavering commitment to deliver
Better Health and a Brighter Future to people around the
world.Here, you will be a vital contributor to our inspiring, bold
mission.POSITION OBJECTIVES:
- Manage deferrals, exceptions, and basis label communication and
triage working closely with LOC RAPs, Global Labeling, and other
members of the Global Labeling Compliance team.
- Partner with internal stakeholders and external CRO partners
such as Global Regulatory Compliance, Global Labeling, IT, Global
Regulatory Operations, GPSE, Regulatory Therapeutic Areas, Local
Operating Companies and Supply Chain for successful day-to-day
activities of labeling compliance.
- CAPAs/QEPOSITION ACCOUNTABILITIES:
- With Global Labeling Compliance leadership, provides Global
Labeling Compliance support for internal and external audits:
- Ensure inspection readiness
- Coordinates Global labeling documentation requests prior to,
during and in follow up to inspections/audits
- Supports the development of responses and CAPAs related global
labeling for audits/inspections
- Escalate issues/problems to management as needed
- Maintains strong knowledge of current regulations, legislation,
best practices and guidelines relating to Regulatory Affairs and
labeling.
- Represents Labeling Compliance on strategic initiatives
impacting labeling event management systems and labeling compliance
activities.
- Supports work on business partner agreements related to
labeling activitiesCORE ELEMENTS RELATED TO THIS ROLE
- Strong knowledge of the regulatory labeling requirements on
major markets like EU, USA, Canada, U.K. and other international
markets.
- This role is global and has cross-functional collaboration
across multiple parts of the Regulatory, Regulatory Compliance,
Quality and R&D groups including TAU, MPG, Global Labeling,
Labeling Operations and CROs.
- Quality System, Regulatory drug development experience,
submission planning, regulatory project management and IT technical
saviness is key for this role to be successful.
- Systems Knowledge -knowledge of Quality Management Systems,
including Deviation (Trackwise) systems.Technical/Functional (Line)
Expertise
- Comprehensive understanding of the pharmaceutical industry and
the labeling regulatory requirements.
- Comprehensive understanding of the Regulatory Compliance
function. Leadership -
- Demonstrated ability to work across functions, regions and
cultures
- Excellent communicator, able to persuasively convey both ideas
and data, verbally and in writing
- Proven skills as an effective team player who can engender
credibility and confidence within and outside the company
- Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organization
- Builds teams across functions and geographies with individuals
who have the right skills and experience to deliver on key
organizational initiatives.
- Invests time in helping others to enhance their skills and
perform at a higher levelDecision-making and Autonomy
- Provide input to highly complex decisions that impact the
functional area
- Accountable for providing input to and implementing vision and
strategy for designated scopeInteraction
- Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
- Cultivates a broad network of relationships throughout Takeda,
with affiliates and external partners, in the industry and area of
expertise.
- Ability to build strong relationships and collaborate
effectively with other interfacing Takeda functionsInnovation
- Comfortable challenging the status quo and bringing forward
innovative solutions
- Ability to take risks implementing innovative solutions,
accelerating time to market
- Identifies opportunities and anticipates changes in the
business landscape through an understanding and ongoing assessment
of the environment affecting the business.Complexity
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS: -
- Bachelor's degree (or equivalent) required. Masters
preferred.
- 6 plus years' experience in Pharmaceutical industry, with
exposure to Regulatory Affairs, labeling, and/or quality
assurance/compliance (or equivalent).
- Familiarity with inspections and audit procedures
- Ability to identify risk of non-compliance in a complex
environment
- Practical operational experience of working across disciplines
and across multiple regions. Experience working within a global
team framework and a multi-cultural environment. -
- Able to manage both time and priority constraints and to manage
multiple priorities simultaneouslyWHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
Plan
- Tuition reimbursement Company match of charitable
contributions
- 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 ProgramsEffective November 1, 2021, absent
an approved religious or medical reason, all US office-based and
lab-based Takeda employees who work fully on-site or in a hybrid
model (as determined by Takeda) must be fully vaccinated to work at
a Takeda site or to engage with Takeda colleagues or anyone else on
behalf of Takeda. As of the same date, absent an approved religious
or medical reason, US field-based employees, employees must be
fully vaccinated in order to continue in their current roles. - US
employees who work at a Takeda manufacturing facility, and those
who work at a BioLife center or BioLife lab, may be subject to
different guidelines. Candidates are encouraged to speak with their
recruiter to seek further information on the applicable guidelines
for the Business Unit/Function for which they have
applied.Empowering Our People to ShineDiscover more at
takedajobs.comNo Phone Calls or Recruiters Please.This job posting
excludes CO applicants.#LI-SGMEEO 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.LocationsCambridge,
MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Trenton , Senior Manager, GRA, Labeling Compliance, Executive , Lambertville, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...