Clinical & Regulatory Writing

Location: Boston, MA - Hybrid (3 days onsite - 2 days remote)

Key Responsibilities:

Lead medical writing activities for clinical and regulatory submissions.
Independently author complex clinical and regulatory documents.
Coordinate clinical sections of complex regulatory filings and MAAs.
Provide strategic guidance across clinical programs and cross-functional teams.
Lead/manage Medical Writing Science team activities and staff development.
Drive process improvements, new technologies, and document development initiatives.
Identify risks and develop solutions to complex regulatory writing challenges.

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