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Medical Writer
Il y a 2 mois
The Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2) manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, 3) mentor junior writers, and 4) oversee vendor writer activities..
Key Responsibilities:
Coordinate medical writing activities and deliverables across multiple projects
Work cross-functionally to write clinical and regulatory documents in support of regulatory submissions to accurately and consistently present key clinical messages in accordance with program goals, regulatory requirements, standards, and guidelines
Serve as the main medical writing contact on study teams, coordinating the efforts of cross-functional teams for document development
Detailed scheduling and management of cross-functional team deliverables impacting document delivery at the program level
Mentor and manage the work of more junior writers
Manage the work and deliverables of contract/vendor writers
Soft Skills :
· Medical studies
· Good knowledge of clinics trials environment
· Good communication skills
· English required
