Medical Writer II

Job Description : 

Essential Function

Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as primary technical contact with client under appropriate departmental supervision.

Relationships

Reports To Departmental Line Management, Medical Writing Services

Directly Supervises None

Provides Work Direction to Medical Writer I, Associate Medical Writer, Medical Writing Assistant

Works Closely with Project Managers/Leaders Physicians, Biostatisticians, Data Managers, Regulatory Associates, Medical Writing staff

External Relationships Client technical representatives

Key Accountability

• Write clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates.

• Serve as the primary client contact, negotiating deliverable timelines, and resolving project related issues, under departmental supervision. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.

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