Global Labeling Operations Specialist, High Wycombe
Client:
Johnson and Johnson
Location:
High Wycombe, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
e94454e5724d
Job Description:
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.
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Product Submissions and Registration
Job Category: Professional
Job Posting Locations: Beerse, Antwerp, Belgium; High Wycombe, Buckinghamshire, United Kingdom; Leiden, Netherlands
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:
1. 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.
2. Track key labeling milestones and deliverables using tracking tools, document repositories, and other related systems and technologies.
3. Support the development, preparation, monitoring, and communication of Key Performance Indicators (KPIs) and metrics related to comparator labels and other labeling outputs and processes.
4. Manage/monitor process communications, department mailboxes, and collaboration portals.
5. Provide input and support for audits and inspections.
6. Support process improvements and successful communication and collaboration within Global Labeling and across business partners.
Qualifications:
1. A minimum of a Bachelor’s degree is required, preferably in a scientific discipline.
2. 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.
3. An understanding of the pharmaceutical development process is required.
4. Knowledge of labeling processes and systems is required.
5. Knowledge of clinical trial legislation, management, and associated labeling requirements preferred.
6. Experience supporting clinical trials in a pharmaceutical setting is preferred.
7. Experience monitoring deliverables and milestones within labeling or other regulatory processes preferred.
8. Experience planning, scheduling, facilitating meetings across stakeholder groups is preferred.
9. Experience working with dashboards and metrics (e.g., Tableau) is preferred.
10. Experience with Microsoft Teams tools and apps is preferred.
11. Must have excellent verbal and written communication skills.
12. Must have strong organizational and collaboration skills.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button.
#J-18808-Ljbffr