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Ability to work independently with little supervision
Ability to optimize and standardize writing practices forthe company
Has utilized and understands ICMJE, GPP writing guides
Previously participated in writing / editing of peer reviewed scientific journal articles. Comprehends medical scientific data.
Previously held leadership position as a Medical Writer in a pharmaceutical company. Has experience with standard clinical documents such as Investigator Brochures, Clinical Study Reports, and the clinical sections of regulatory submissions.
Experience with confidential data
Ability to work with both internal and external personnel in a collaborative fashion.
Ability to interact well with KOLs and to work in a fast paced environment.
Project management of document flow from origin to completion.
Ensure the creation of high quality final documents by monitoring writing from draft to finalization
Meet timelines for submission of specific documents.
Write or edit documents as required. Develop synopsis of complex data as an abstract or for a visual display ensuring that key messages are clear.
Search and obtain key journal articles for review by team and use as references in written documents.
Formulate writing templates for use by team members