Sr. Manager Labeling
Company: Jazz Pharma
Location: Palo Alto
Posted on: February 22, 2021
Jazz Pharmaceuticals is an international biopharmaceutical company
focused on improving patients' lives by identifying, developing and
commercializing meaningful products that address unmet medical
needs. We are continuing to expand our commercial product portfolio
and our research and development pipeline in therapeutic areas that
can leverage our unique expertise.
Our therapeutic areas of focus include sleep and
hematology/oncology - areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.
We are looking for the best and brightest talent to join our team.
If you're looking to be a part of a company with an unwavering
commitment to improving patients' lives and being a great place to
work, we hope you'll explore our career openings and get to know
The Senior Manager, Global Labeling (Neuro) will be responsible for
regulatory support in the area of product labelling for Jazz
Pharmaceuticals. This position reports to the Director, Global
Labeling and will be will be responsible for key functions
including creating, updating and maintaining labeling documents
throughout the product lifecycle, with primary focus on Company
Core Data Sheets and regional/local labels for products marketed
globally. This position will help maintain controlled records for
historical labeling changes, and communicate labeling changes to
stakeholders at the time of implementation. As needed, this
position will also support the implementation of process
improvement changes to increase the efficiency and effectiveness of
labeling processes. This position will interact with Regulatory
Affairs colleagues and interact cross-functionally with members of
the Clinical, Medical, Legal, Safety, Commercial, Quality and
Supply Chain organizations.
* Maintain expertise regarding key labeling requirements worldwide
and stay current with labelling regulations and guidance as they
pertain to the development/maintenance of labeling; and advise key
stakeholders on the application of these labeling principles.
* Provide project management to the Labeling Team throughout the
entire process, from the decision to update a CCDS/USPI/SmPC or
other labeling document (including patient information labelling
such as Med Guides, IFUs, PIL), to ensure that labeling documents
are produced in a timely manner according to internal SOPs and
external regulatory requirements.
* Responsible for proofreading and departmental QC work.
* When developing new labels, research the content of other labels
in the same therapeutic class, including competitor labeling, to
help guide the team in developing labeling text, including
contingency strategy development for negotiation with regulatory
* Schedule, coordinate and lead LC meetings, and coordinate
* Maintain controlled records for historical, current and proposed
labeling changes, including labelling compliance activities
(management of product information on corporate labeling webpages,
as well as participating in audit and inspections as required).
* Communicate labeling changes to stakeholders at the time of
implementation, including PRA and Medical Information
* Maintain awareness of regulatory legislation pertaining to
labeling; assessing and communicating the impact on Jazz business
* Manage quality control over entire labeling process and
management of revisions, including assigning, tracking projects,
workflow execution, and issue resolution.
* Assist in implementing process improvements to increase the
efficiency and effectiveness of the label review process.
* Lead and manage more junior labeling roles as required.
Required Knowledge, Skills, and Abilities
* Minimum of 7 years' experience in the pharmaceutical industry,
with 4 as direct experience in Global Labeling or 3 in other
regulatory affairs function(s).
* Proven experience in regulatory affairs with particular focus on
* Experience associated with global product labeling regulations
* Strong judgment and decision-making skills
* Excellent verbal and written communication skills and
collaborative interpersonal skills.
* Ability to review regulatory labeling documents for accuracy and
adherence to regulatory requirements, noting deficiencies and
* Must be able to work successfully within a team/partnership
environment and as an individual contributor, with a high level of
* Ability to travel occasionally - approximately 10-20% regional
and/or international travel
* Responsibilities may require working outside of "normal" hours,
in order to meet business demands.
Required/Preferred Education and Licenses
* Bachelor's degree required (Scientific discipline preferred) (or
equivalent in industry related experience)
Jazz Pharmaceuticals is an equal opportunity/affirmative action
employer and all qualified applicants will receive consideration
for employment without regard to race, color, religion, sex,
national origin, disability status, protected veteran status, or
any characteristic protected by law.
Keywords: Jazz Pharma, Palo Alto , Sr. Manager Labeling, Executive , Palo Alto, California
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