Associate Director, Global Labeling Product Leader
Company: Janssen
Location: Titusville
Posted on: June 23, 2022
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Job Description:
Janssen Research & Development, L.L.C., a member of Johnson &
Johnson's Family of Companies, is recruiting for an Associate
Director Global Labeling Product Leader in Titusville, NJ, Raritan,
NJ or Spring House, PA, Toronto, Ontario (CA), UK (High Wycombe),
Netherlands (Leiden), Belgium (Beerse), or Switzerland (Allschwil,
Bern, Zug) or Remote work options may be considered, on a
case-by-case basis and if approved by the Company.At the Janssen
Pharmaceutical Companies of Johnson & Johnson, we are working to
create a world without disease. Transforming lives by finding new
and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world
for the health of everyone in it. Learn more at and follow us
@JanssenGlobal. Janssen Research & Development, LLC is part of the
Janssen Pharmaceutical Companies.Our company thrives on diverse
company culture, celebrating the uniqueness of our employees, and
is committed to inclusion. Janssen is proud to be an equal
opportunity employer. Our culture is interconnected by the shared
values of Our Credo. It is a culture that celebrates diversity and
diverse perspectives and helps its employees achieve an effective
balance between work and home life and supports their efforts to
have a positive impact on their communities.Key
Responsibilities:Have oversight and responsibility for the
development, revision, review, approval and maintenance of primary
and derived labeling documents for assigned compounds in assigned
portfolio.Manage compounds with a certain degree of complexity from
a labeling perspective.Create and maintain primary labeling
documents the Company Core Data Sheet (CCDS), United States Package
Insert (USPI) and associated patient labeling, EU Product
Information (EUPI) and derived documents (labeling text for EU,
US).Coordinate the development, revision, review, and approval of
primary and derived labeling documents, including the Labeling
Working Group (LWG) and Labeling Committee (LC) activities related
to these documents.Ensure the dissemination of LC-approved CCDS,
USPI, EUPI, and derived labeling documents and supporting
documentation; ensure the quality of labeling deliverables (e.g.,
alignment of labeling text with data, regulatory requirements,
consistency between labeling documents).Contribute to and implement
the global labeling strategy including the development of target
labeling.Contribute to the continuous improvement of the end-to-end
labeling process.QualificationsQualificationsEducation:A minimum of
a Bachelors degree or equivalent is required.A degree in a
scientific subject area (highly preferred)An advanced degree (MS,
PhD, MD or PharmD) (is highly preferred)Experience and
Skills:Required:Minimum of 8 years of professional
experienceRelevant experience in the pharmaceutical industry (e.g.,
Regulatory Affairs, Clinical, Medical Information,
Pharmacovigilance) including at least 6 years of direct regulatory
labeling content experience or equivalentAn understanding of
prescription pharmaceutical drug developmentPreferred:Previous
experience working within a regulatory labeling function developing
labeling content for pharmaceutical productsExperience working in
Documentum-based systemsExperience leading project teamsSolid
understanding of biology and pharmacologyA demonstrated proactive
approach, experience leading continuous improvement projects, and
exceptional verbal and written communication, negotiation, and
partnering skillsDemonstrated ability to drive a collaborative,
customer-focused, learning cultureOther:At Johnson & Johnson, were
on a mission to change the trajectory of health for humanity. That
starts by creating the worlds healthiest workforce. Through
groundbreaking programs and policies, we empower the physical,
mental, emotional, and financial health of our employees and the
ones they love. As such, candidates offered employment must show
proof of COVID-19 vaccination or secure an approved accommodation
prior to employment to support the well-being of our employees,
their families, and the communities in which we live and work.We
will ensure that individuals with disabilities are provided
reasonable accommodation to participate in the job application or
interview process, perform essential job functions, and receive
other benefits and privileges of employment. Please contact us to
request accommodation.Johnson & Johnson is an Affirmative Action
and Equal Opportunity Employer. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, age, national
origin, or protected veteran status and will not be discriminated
against on the basis of disability.Primary LocationUnited
Kingdom-England-High Wycombe-Other LocationsEurope/Middle
East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland,
North America-United States-New Jersey-Raritan, Europe/Middle
East/Africa-Belgium, North America-United
States-Pennsylvania-Spring House, Canada-Ontario-Toronto, United
States-New Jersey-TitusvilleOrganizationJanssen Cilag Ltd.
(7360)Job FunctionRegulatory AffairsRequisition ID2206042347W
Keywords: Janssen, Trenton , Associate Director, Global Labeling Product Leader, Executive , Titusville, New Jersey
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