EU/International Regulatory Strategy Intern

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About Vertex

Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.

EU/International Regulatory Strategy Intern

The intern will be assigned at least one specific project to work on for the majority of their time here.   This is likely to involve elements of:

• Research: therapeutic area, Regulatory precedent and competitor intelligence research to support development of strategies for one or more development or marketed products; reviewing new draft guidelines and publications.
• Writing & communication: with supervision, assisting with drafting documents and presentations e.g. for meetings with Regulatory authorities to seek advice on development pathways.   Creating written summaries and presentations on new guidelines, regulatory precedent or other ‘hot topics’ to inform the International Regulatory strategy team and for discussion.
• Operations & process improvements: organizing existing intelligence information, creating new templates, working with colleagues in the Regulatory strategy team to understand our existing processes and look for opportunities to streamline them.   Assisting with preparations for Regulatory authority meetings.   Potentially (with supervision) putting together simple Regulatory submissions such as Clinical Trial Applications or amendments.

During their time with the team, the intern will be supervised by senior team-members and will work in a close matrixed organization with other members of the Regulatory Affairs team, primarily face to face in the London office but also remotely at the Boston US office.  
 
There will be opportunities to ‘shadow’ and participate at cross-functional meetings in person at the London office and via teleconference with Boston, which will provide additional exposure and insight into Commercial/Marketing, Supply Chain, Government Affairs, Clinical Development and Pharmacovigilance   functions, and how all these functions interact with Regulatory Affairs.

Qualifications

• Second year of a Bachelor’s Degree in life sciences, social sciences, business, law, politics or government affairs (if your main degree subject is not life sciences, you should have at least one science subject at A-level or equivalent).
• High level of IT literacy and ability to pick up new systems and processes

How to apply

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