Director Global Labeling Strategy
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: January 24, 2023
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Job Description:
Join a Legacy of Innovation 110 Years and Counting!Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 100 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 15,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. Under the Group's 2025 Vision to become a
"Global Pharma Innovator with Competitive Advantage in Oncology,"
Daiichi Sankyo is primarily focused on providing novel therapies in
oncology, as well as other research areas centered around rare
diseases and immune disorders.SummaryThis position serves as the
Global Regulatory Affairs (GRA) Labeling Strategy expert to the
Global Product Team (GPT) as an ad hoc member and independently
provides strategic and operational leadership on new product
labeling in collaboration with the Global Regulatory Leads (GRLs)
and Clinical Safety & Pharmacovigilance (CSPV) for assigned
products. This position drives/leads the development and
maintenance of the CCDS, US and EU labeling, and manages the review
of country labeling deviations for assigned Daiichi Sankyo products
ensuring compliance with all applicable Health Authority (HA)
regulations and guidelines, internal company procedures and company
business objectives. This positions manages new projects and
projects of increased complexity including those involving 3rd
party collaborators The position may manage a team of Global
Labeling Leads (GLLs) and/or serve as the Labeling Project Lead.
This position leads labeling meetings for preparation of responses
to comments from HAs, meeting required timelines to achieve final
labeling approval. Additionally, this position mentors and may
manage assigned staff, partnering with the Global Labeling
Operations & Compliance group and across the cross-functional and
cross- regional representatives on the labeling review teams as
well as with business partners to achieve high quality and accurate
labeling in support of business
objectives.ResponsibilitiesPreparation of new and updated Core Data
Sheets, EU and US Documentation: As the project lead, Independently
or through direction of a team of GLLs, manage, develop prepare and
implement regulatory documents (e.g., draft launch labeling, USPI,
annotated labeling, medication guides, EU SmPC, EU PL, CCDS,
CCPL)for new products or products in the development phase.
Independently lead cross functional teams through all labeling
discussions with the FDA/CHMP while ensuring management alignment.
Strategize and plan for FDA meetings as needed. Acts as point of
contact for cross-functional teams on RA labeling issues.
Collaborate with Regulatory Affairs and Labeling colleagues in
other regions, including Japan, while developing the CCDS.Ensure
Compliance with Core Data Sheets/Label Changes: Develop and
communicate strategic labeling development strategic plan to other
project team GLLs and to cross-functional labeling review team
members. Responsible for the broad oversight of Core Data Sheets
and US/EU label changes for products in the development phase,
including across overlapping updates managed by multiple GLLs.
Manage US and local country labeling deviations from CCDS; review
and approve CCDS/labeling agreements for licensing partners.Conduct
Label Review Committee Meetings: Independently or through oversight
of a team of GLLs, prepare labeling documents for review. Lead
review processes to ensure appropriate review and governance by
Daiichi Sankyo, and where applicable, partner companies for the
development and approval of US, EU and global CCDS documents for
regulatory filings and HA labeling discussions. Collaborate with
colleagues in Japan to ensure timeline review of labeling
deviations by the appropriate labeling committees. Collaborate with
country RA to ensure appropriate background is provided to the
labeling review team members for the consideration of labeling
deviation requests for Daiichi Sankyo and partner companies, if
applicable.Ensure Compliance with Labeling Regulations and
Guidances: Demonstrate expert knowledge of global labeling
guidances. Ensure compliance with internal and external labeling
guidelines, reviewing US and EU package inserts for assigned
products with regard to both content and format. Ensure compliance
with internal processes for record keeping and tracking of labeling
milestones. Collaborate with Global Labeling Operations and
Compliance leads to product high quality labeling
documentation.Establishes Process Best Practices: Serve as a role
model for less experienced members of GRA labeling, labeling review
teams and partner companies, reinforcing the use and implementation
of labeling best practices. Assist or lead the development of
Standard Operating Procedures (SOPs) and process improvements.
Conduct team meetings with direct reports or a team of GLLs to
ensure alignment of labeling content and strategy and to optimize
resourcesDepartment Coordination: Builds cross-functional and
cross-regional relationships.People Management: Mentor, develop and
managed assigned staff and/or matrix team members.Qualifications:
Successful candidates will be able to meet the qualifications below
with or without a reasonable accommodation.Education Qualifications
(from an accredited college or university)Bachelor's Degree
preferably in a scientific discipline; requiredAdvanced degree
(e.g., Masters, Pharm.D., Ph.D.) preferredExperience
Qualifications10 or More Years pharmaceutical industry experience
required4 or More Years of direct regulatory affairs experience,
including CCDS and US/EU labeling experience requiredExperience
with country labeling a plus (outside the US/EU) preferredDaiichi
Sankyo, Inc. is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment
without regard to sex, gender identity, sexual orientation, race,
color, religion, national origin, disability, protected veteran
status, age, or any other characteristic protected by law.
Keywords: Daiichi Sankyo, Inc., Newark , Director Global Labeling Strategy, Executive , Basking Ridge, New Jersey
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