Senior Associate- Publishing, Global Regulatory Operations
Company: Jazz Pharma
Posted on: February 25, 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 Global Regulatory Operations Senior Associate is responsible
for preparing/publishing documentation for commercial and
development projects for submissions to global health
* Support Regulatory Affairs team in planning, publishing,
submission, and archive of regulatory documents.
* Ensures compliant, high quality, timely submissions in accordance
with current and emerging Health Authority guidance across multiple
regions, including, but not limited to US and Canada.
* Work across company disciplines and represent Global Regulatory
Operations on assigned project and/or task teams to effectively
communicate and drive timings and deliverables.
* Publish documents intended for regulatory submissions in
accordance with company style and relevant guidance documents to
ensure they meet requirements for electronic submissions and
optimal global utilization.
* Prepare and publish regulatory submissions in eCTD format,
including, but not limited to: amendments; supplements;
periodic/annual reports; promotional materials and meeting
* Assist in the maintenance of document standards, templates, and
procedures related to the formatting, publishing and archiving of
electronic submissions according to company regulatory
* Maintain records in Regulatory Information Management (RIM)
Required Knowledge, Skills, and Abilities
* Direct experience with publishing, compiling, preparing and QC of
documents for eCTD submissions.
* Demonstrates a working knowledge of Regulatory Information
Management system and publishing technologies. Experience with
Global Submit Review/Publish, ISIToolBox, Starting Point templates,
and Veeva Vault a plus.
* Ability to work independently with moderate supervision on
multiple projects simultaneously.
* Detail oriented with creative problem solving and troubleshooting
* Strong written and verbal communication skills.
* Strong team building skills.
* Exceptional interpersonal skills with the ability to work
individually and within multi-disciplinary teams.
* Some travel required.
Required/Preferred Education and Licenses
* BS/BA or equivalent industry experience.
* 5+ years of Regulatory Operations experience preferred.
Description of Physical Demands
* Occasional mobility within office environment.
* Routinely sitting for extended periods of time.
* Constantly operating a computer, printer, telephone and other
similar office machinery.
Description of Work Environment
* Work indoors in normal office environment with little exposure to
excessive noise, dust, fumes, vibrations and temperature
* Frequent computer use at workstation.
* May move from one work location to another occasionally.
* Responsibilities may require a work schedule that may include
working outside of "normal" work hours, in order to meet business
* Occasional public contact requiring appropriate business
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, Philadelphia , Senior Associate- Publishing, Global Regulatory Operations, Advertising , Philadelphia, Pennsylvania
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