Function as a lead writer to prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) in collaboration with members of client authoring teams and supported by other , as appropriate. - At least 5 years of experience of actively writing regulatory documents; experience as a lead writer on CTD documents is mandatory. - Must have worked as the lead writer on several key regulatory documents such as: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications. - Must have experience as the lead writer with multiple-document projects with global, multinational teams, including t
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