We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.
Who are we?
We Are PRA.
We are 20,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
You are someone who is self-motivated, driven and likes to be part of a team. You have an understanding of compliance and have been successful with managing multiple projects, and tracking deliverables. You are someone who likes to review and harmonize processes and has a strong customer service focus
Still here? Good. Because if this is you, we’d really like to meet you.
What you will be doing:
The PRA Labeling Compliance team is responsible for Global Labeling (GL) processes including the preparation of regulatory and compliance tracking reports, metrics tracking and preparation, maintenance of the QMS system, audit/inspection support, and IT systems supporting GL activities. The Global Labeling Specialist provides support to these functions under direction of the Senior Manager of Global Labeling Compliance.
- TrackWise / Change Control for Global Labelling
- Monitor progress, identified risks, and propose solutions/improvements.
- Ensure that the Change Control process is followed for GL updates, to maintain compliance KPIs
- Proactively raises labelling concerns, risks and issues that may delay/ impact and presents risk for labelling.
- Support Corrective and Preventative Actions (CAPAs)
- Support tracking of Global Labelling compliance, providing data and summary reports to client GL management as requested.
- Support Dependency/Deferral requests.
- Support escalation of any non-response/possible non-compliance issues.
- Build and maintain strong collaborative relationships with key internal and external stakeholders, including Global Labelling (GL), Global Regulatory Affairs Compliance (GRAC), Quality Assurance (QA), Global Labelling Operations (GLO), Medical Affairs, Manufacturing, Supply Chain and other key functions as required, to ensure labelling objectives are met.
What you need to have:
- BS/BA degree preferred in a scientific or technical field, including Computer and IT
- Experience working in the pharmaceutical industry, including global labeling/CCDS experience
- EU labeling experience
- TrackWise / Change Control for Global Labelling – minimum 2 years’ experience
- Excellent oral and written communication skills.
- Ability to work in a team environment but can function equally well independently.
- Strong customer support skills
- Clear and effective written and verbal communication skills
- Proactive problem-solving mindset
- Exceptional attention to detail with strong organizational skills
- Proven ability to manage multiple priorities and meet deadlines
- Demonstrated ability to build strong relationships and work with diverse personalities
- Understanding of scientific principles and regulatory/quality/pharmacovigilance systems relevant to drug development
- Demonstrated ability to manage projects, assess and integrate information, identify and clearly communicate potential issues, and propose solutions
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
- Travel: approximately 20% travel may be required.