Project Assistant – Regulatory Affairs

Job Summary :

Our European activities are growing rapidly, and we are currently seeking a full\-time Project Assistant in Stirling, Scotland, or London, England, UK to join our Regulatory Affairs team, supporting two of our key sub\- teams within the department:

• The central labelling team in development of clinical trial labels


• The regulatory intelligence team to help maintain a central database

This fully office\-based position will provide daily administrative support to the teams to accomplish tasks and projects that are instrumental to the company’s success. If you want a new role with a stable organization then this is the opportunity for you.
Responsibilities :

• Member of a small team managing the label review, country adaptation and translation process.


• Creating country specific labels in English, using our in\-house database.


• Coordinating multiple translations with our vendor companies and local associates.


• Interacting with Medpace staff globally to finalise label reviews.


• Tracking progress and working to deadlines on multiple projects.


• Performing quality control of labels.


• Coordinating and providing minutes for departmental meetings/conference calls.


• Updating the EMA CTIS portal (clinical trial applications)


• Communicate weekly and monthly regulatory intelligence updates


• Tracking of regulatory intelligence updates globally


• Support for regulatory intelligence team activities


• Performing other tasks as needed.

Qualifications :

• Experience in a detailed administrative role preferred.


• Relevant HNC/HND in an administrative field \- desirable


• A\-levels/Highers in English or Maths \- desirable, GCSEs/National 5 – requirement (English, Science and Maths grade 6 – 9/A\-C)


• Great attention to detail.


• Ability to work well in a team environment.


• Excellent organizational and prioritization skills. Work experience in a health science setting preferred.


• Excellent oral and written communication skills in English language.


• Knowledge of Microsoft® Office.

Medpace Overview :

Medpace is a full\-service clinical contract research organization (CRO). We provide Phase I\-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti\-viral and anti\-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40\+ countries.
Why Medpace? :

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30\+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

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