Global Labeling Operations Specialist

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):


* United States - Requisition Number: R-003029


* United Kingdom, Belgium, Netherlands - Requisition Number: R-006636

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Global Labeling Operations Specialist.

 This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

The Global Labeling Operations Specialist will be responsible for the following:


* Act in role of Reference Safety Information (RSI) steward in support of Clinical Trial management, including monitoring changes to comparator labels.  Communicate changes to Clinical, Safety, and Regulatory teams in accordance with documented timelines; and tracking completion of impact assessments.


* Track key labeling milestones and deliverables using tracking tools, document repositories, and other related systems and technologies.


* Support the development, preparation, monitoring, and communication of Key Performance Indicators (KPIs) and metrics related to comparator labels and other labeling outputs and processes.


* Manage/monitor process communications, department mailboxes, and collaboration portals.


* Provide input and support for audits and inspections.


* Support process improve...