Hobson Prior have a new opportunity for a Medical Technical Writer to join a fantastic global biotechnology organisation on a permanent basis in Germany, where working from home from anywhere in Europe is available. For more information, please get in touch!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be responsible for overseeing clinical study protocols, clinical study reports, and investigators brochures.
• In cross-functional working groups you contribute to the overall project management to facilitate efficient development and finalization of regulatory documents for submission.
• You will be writing up CMC documents and reports from different suppliers and sources of data will also be your task.
• You will be a part in the company's branch working in the Team that is responsible for Regulatory Affairs in EU.
• Writing of submission relevant documents, which include among others Module 5 sections and Module 2 (i.e. clinical summaries and overviews) in CTD format for submission to FDA and EMA, study reports, answer questions related to Module 5 and paediatric plans (PIP) and orphan maintenance reports.

Key Skills:

• Strong communication skills.
• Excellent time and priority management and work efficiently.

Requirements:

• The ideal candidate will have a bachelors or masters degree in a scientific study program or you finished a scientific/technical apprenticeship with success.
• At least 2 years' experience in Regulatory Medical Writing is mandatory.
• A strong knowledge of CTD documents, clinical study reports, study protocols, and investigator brochures is needed Further you should have experience in writing the SmPC or PI in generell.
• Fluent in English (written and spoken).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.