Senior Regulatory Affairs Consultant - CTR Project Manager
Remote, Ireland | Parexel
Industry:Pharmaceutical / Biotech
Consulting - Strategy
Job Description:58 people have viewed this job
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. This role can be based in either UK or UE (home/office based) and we have flexibility on levels.
In this role you will work 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 will work 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 also deliver 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.
- Draw models for the business processes (process flows)
- Moderate workshops with business experts
- Capture the User Requirements
- Formally document User Requirements
- Coordinate analysis and activities with IT Project Manager
- Ensure good communication with stakeholders in the project (verbally and written)
- Draft new procedures based on new business processes & user requirements
- Create training material and reference guides
- Evaluate new system packages for implementaion
- Write & run user test cases
- Provide support to end-users
- Design and generate reports for stakeholders
- Design and maintain KPIs on system data
- Design and QC metrics to monitor system data quality
- Liaise with other operational teams for system inter-operability
- Work with external partners and authorities for data update and data exchange with authorities (e.g. EMA for XEVMPD, IDMP)
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.
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