Beschreibung
* Strong knowledge and experience in safety related documents (e.g. DSURs, PBRERs, Risk Management Plans, Signal Evaluation Reports, Benefit-Risk Strategy Documents)* Understanding of the safety strategy related to these documents and to regulatory submissions
* Ability to coordinate vendor resources and to track timelines and priorities of documents together with safety project management
* Technical expertise in Microsoft Office suite, MW Word templates, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
* Ability to maintain familiarity with current industry practices, regulatory requirements, and guidelines that affect Medical Writing
* Strong communication skills (verbal, written, and listening) in English with the ability to interpret and summarize complex data
90% remote, 10% Darmstadt
Start of project: 15.10.2021
End of project: 14.10.2022
Schlagwörter:
medical writing, medical, writing, pharma, arzt, freelance, freelancer, freiberuflich, freiberufler, projekt, project, life science, dokumentation, management, darmstadt, remote, home office, homeoffice, Dokumentation, Medizin, Biology, Biologie,
Kontaktperson: Personalreferentin Frau Julia-Elisabeth Kratz
FERCHAU GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt