Global Labeling Operations Specialist

undly impact health for humanity. Learn more at https://https://www.jnj.com

Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands
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://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 High Wycombe, United Kingdom; Beerse, Belgium; or Leiden, Netherlands.

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 improvements and successful communication and collaboration within Global Labeling and across business partners.

Qualifications:

• A minimum of a Bachelor's degree is required, preferably in a scientific discipline.

• A minimum 3 years of experience supporting labeling development, implementation, and/or operations within the Pharmaceutical industry or experience supporting Regulatory processes associated with clinical trial management and execution is required.

• An understanding of the pharmaceutical development process is required.

• Knowledge of labeling processes and systems is required.

• Knowledge of clinical trial legislation, management, and associated labeling requirements preferred.

• Experience supporting clinical trials in a pharmaceutical setting is preferred.

• Experience monitoring deliverables and milestones within labeling or other regulatory processes preferred.

• Experience planning, scheduling, facilitating meetings across stakeholder groups is preferred.

• Experience working with dashboards and metrics (e.g., Tableau) is preferred.

• Experience with Microsoft Teams tools and apps is preferred

• Must have excellent verbal and written communication skills.

• Must have strong organizational and collaboration skills.

#LI-Hybrid