-Responsible for writing documents owned by regulatory in collaboration with other functions (e.g.
the IMPDs, INDs, Briefing Books, ODDs, PIPs or similar for the US, FTDs, BTDs and IND annual reports).
-Proof read and provide editorial support on documents/responses produced by other functions, if requested.
-Compile documentation to support high quality regulatory submissions and responses to questions from regulatory authorities.
-Collaborate with the project lead responsible for regulatory affairs to establish timelines regarding regulatory document writing and submissions.
-Contribute to reviewing/editing documents owned by other functions (e.g.
clinical protocols, IBs, DSURs, CSRs…) if needed.
Profile required :
-Bachelor's degree in a scientific discipline; post-graduate scientific degree is preferred.
-At least 5 years medical writing experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.
-Proven experience in writing regulatory documents such as briefing books, IMPDs, INDs.
-Solid writing/editorial skills in English (English Native speaker is a plus).
-Strong ability to prioritize and manage multiple demands and projects with respect to deadlines.
-Ability to communicate scientific or medical information in a clear and concise manner.
-Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously in cross-functional teams.
-Must be able to work autonomously and attention to detail.
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