FARMACOLOGIA CLÍNICA - (Scientific & Development Writer)

As a Medical Writer, you will be in charge of the timely and correct execution of projects according to defined timelines :

• Being in charge of the design of clinical plans.
• Creation of the regulatory strategy for First-in-Human Clinical trials and / or MAA.
• Client and partner management : define milestones, planning and execution of tasks, manage timelines, project reporting.
• Liaison with health authorities for drug development procedures and / or Pre-submission meetings.
• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
• Direct contact with clients and interaction with multidisciplinary teams across the company, optimizing projects and development programs.

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