Medical Writing

The medical writer’s essential role is to guide all medical writing activities for clinical and regulatory documents for regulatory submissions of clinical and regulatory documents.

To deliver quality, interpretable regulatory documents, Medical Writing leads the writing strategy, while offering expertise in organization, content, timeline management, and resource allocation oversight of both internal and external stakeholders.

The Medical Writer will tabulate and collate stakeholder input with study design, clinical summary modules of INDs, protocols, Clinical Study Reports, and marketing applications into quality regulatory documents for FDA submission.

The development and execution of sound Medical Writing strategy involves the following:

Non-technical

responsibilities of the medical writer:

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