Senior Regulatory Affairs Consultant - EU CTR Project Manager
- Employer
- Parexel
- Location
- Hungary
- Salary
- Competitive
- Start date
- 10 May 2022
- Closing date
- 9 Jun 2022
View more
- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
We are currently looking for a (Senior) Regulatory Affairs Consultant to join one of our clients and act as EU CTR Submission Project Manager for Regulatory Affairs in Development Delivery.
In this role you willwork closely with IT Project Manager to design, implement applications & systems to support regulatory business processes. This includes the analysis of the demand, the realization of the application through customization/development and testing. You willwork with key stakeholders to map current processes and organize task forces to define and implement process improvements. You will develop documentation and training package and support activities (response to questions from users). You will support the organization by analyzing (as business analyst) and managing and/or coordinating EU CTR process changes and organizational changes. You may alsodeliver project management, compliance and regulatory intelligence in the framework of Clinical Trial Applications (CTA) as per the new EU CT Regulation and the former EU CT directive.
Role responsibilities:
Qualifications
Ideal candidate will possess:
• University degree in a science discipline
•A background in clinical trial management with a specific focus on EU CTR
• Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization, and training.
• Minimum 5 years' experience as Project Manager
IT knowledge (Veeva Regulatory and Clinical Vaults - excel - VBA - powerBI...)
• Solid analysis and synthesis capability;Solution-oriented and problem-solving skills.
• Customer-oriented and autonomous
• Fluency in English is a must along with the local language.
Why Work at Parexel
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.
Company
Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.
Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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