Regulatory affairs placement

This placement will be a good primer to understand the role of a Regulatory Submission Co-ordinator but will also offer insight into other roles in clinical trial space such Clinical Trial Manager and Project Coordinator.

Regulatory Submission Co-ordinator Interns will complete training during their time at Medpace via the Medpace Learning System and will cover the Regulatory Submission Co-ordinator (RSC) job functions and facets of clinical research for drug/biologic and medical device clinical trials. The training encompasses reviews of applicable regulations, ICH-GCP, Medpace SOPs and specialized departmental topics, industry best practices, and therapeutic area modules.

As such the Regulatory Submission Co-ordinator intern will :

·         Become familiar with ICH-GCP guidelines, industry regulations, and Medpace systems;

·         Complete training to become familiar with the Regulatory Submission Co-ordinator role

·         Provide day to day departmental support activities as necessary; Examples include but are not limited to customising informed consent forms and patient materials, preparing submission applications, etc.; 

·         Coordinate and provide minutes for departmental meetings/conference calls as and when required; 

·         Maintain database/spreadsheets and compile reports as necessary to facilitate tracking/documentation of departmental activities;

·         Conduct quality control reviews of departmental documents as necessary; 

·         Support other departments on ad hoc projects; and

·         Perform other administrative tasks as needed

During the placement the intern may also have the opportunity to:

·         Shadow and meet with other Medpace Departments, (e.g. Clinical Trial Management)

·         Attend meetings between Regulatory Submissions and Functional Area Leads, so they can provide perspective/overview of position.

·         Attend Medpace and sponsor meetings as a silent observer.

·         Working towards a degree in a Life Science related field.

·         Excellent skills in Microsoft Word, Excel, and Outlook.

·         Candidate should have done some research into what a Regulatory Submission Co-ordinator job entails.

• Strong interpersonal skills and ability to collaborate effectively.

• Excellent organizational and prioritization skills and ability to multi-task.

• Great attention to detail and excellent oral and written communication skills.

• Ability to propose solutions/processes to deal with issues that arise and escalate issues where appropriate.

·         Willing to commit to an approx. 10 month placement, full time, in office