Global Labeling Lead
Company: Unicon Pharma
Location: New York
Posted on: November 22, 2021
Location: Princeton, NJ
Duration: Direct Placement
The GLL will support the use and development of current and new
tools, technologies and processes to support efficient global label
development and worldwide submissions and approvals.
The Global Labeling Lead (GLL) has overall accountability for the
initial creation and relevant updates to labeling documents for
their assigned products. This includes guiding the Labeling Team to
develop and maintain Core Data Sheets (CDS), Core Safety
Information (CSI), United States Package Inserts (USPI), Summary of
Product Characteristics (SPC) for products registered in the EU via
the Centralized, Mutual Recognition or Decentralized Procedures,
and their associated Patient Labeling Documents. This may also
include Regulatory Authority driven documents such as the Core
The GLL will guide and advise the Labeling Team on internal
labeling guidances and policies and will raise awareness of
important factors to consider when revising the label. The GLL will
keep up to date with labeling guidelines and regulations as they
pertain to the development/maintenance of US and EU labeling and
will advise the Labeling Team on the application of these labeling
principles. The GLL will also be knowledgeable on key labeling
requirements worldwide, in order to ensure that CDS/CSI updates may
be implemented globally.
The GLL will review the downstream impact of CDS/CSI updates on
Local Product Documents (LPD) and ensure that downstream impact on
LPDs is considered during Labeling Team discussions. The GLL will
advise the Labeling Team on the content of other labels in the same
therapeutic class, including competitor labeling, to help guide the
team in developing labeling text.
The GLL provides project management to the Labeling Team throughout
the entire process, from the decision to update a CDS/CSI/USPI/SPC
through notification to stakeholders in order to ensure that these
documents are produced in a timely manner according to internal
SOPs and external regulatory requirements. This includes setting
clear targets and prioritization plans, ensuring that Labeling
Teams are aware of the required timelines and following up with
Labeling Team members throughout the process so that deliverables
remain on target to meet internal and external deadlines. The GLL
serves as the GLM primary point of contact for Labeling Teams (e.g.
WRS Strategist, Functional Line SMEs, Labeling Justification
Document/Clinical Overview author) and will provide day-to-day
direction to Labeling Operations Specialists so that labeling and
decision documents can be prepared and managed appropriately
throughout Pharmaceutical processes and systems. The GLL also
interfaces with Hub Labeling Managers and PCO colleagues to support
timely and quality submissions globally.
Life sciences, pharmacy graduate or equivalent.
Advanced academic qualifications/degree such as PhD an advantage
but not essential.
Keywords: Unicon Pharma, New York , Global Labeling Lead, Other , New York, New York
Didn't find what you're looking for? Search again!