Medical Writer / FREELANCE (PR-33287429) Baden

EUR100000 - EUR110000 pro Jahr + Freelance

*** Medical Regulatory Writer / Freelance ***

If you have solid know-how on Regulatory Affairs (pharma) and are interested in supporting a freelance project as
Medical Regulatory Writer
(emphasis Regulatory Documentation Overview) for my client in southern Germany, please find enclosed key details for your consideration.

Medical Regulatory Writer

• Detailed examination and evaluation of externally generated approval-relevant clinical and non-clinical documents for correctness, consistency and plausibility
• Acquisition, organization, control and management of external service providers
• Independent preparation of non-clinical and clinical pivotal documents and CTD dossiers such as Clinical / Non-Clinical Overview, Clinical / Non-Clinical Summaries, Expert Statements, etc. according to regulatory and internal guidance for European and global drug authorizations
• Creation, testing and evaluation of information texts (such as user information, SmPCs, a.o.)
• Contact person for regulatory authorities as well as internal clients regarding non-clinical and clinical issues
• Answering Deficiency Letters in relation to non-clinical and clinical issues

Start:

ASAP

Region:

Southern, Germany

Volume:

0,5-1 FTE (with home office possibility)

Duration:

 6 (possible extension and / or take-over)
If your interest arises, please contact me at your earliest convenience to exchange on all other important points.
If you do not have free capacities and / or this is not in line if your current career endeavour, than feel free to pass this opportunity within your network.

Thank you for your time and wishing you a great weekend in advance,
Charlotte Valentiner
 
Senior Recruitment Consultant
Medical Affairs / Market Access / Drug Safety – Freelance & Arbeitnehmerüberlassung
mehr...

zur Vakanz

Weitere Jobs von Aplitrak