Expert Regulatory Medical Writer

Position: Expert Regulatory Medical Writer Role
Lead the development of critical clinical regulatory documents as a Regulatory Medical Writer. This position emphasizes expertise in Clinical Protocols and Investigator's Brochures within a sponsor-embedded setting.

As a Regulatory Medical Writer, you'll oversee the entire lifecycle of Phase II–IV clinical documents, contributing extensively to Clinical Protocols and submissions. Collaborating with cross-functional teams globally, including Biostatistics and Project Physicians, is key to this role. Your proven experience in regulatory medical writing, especially as a project lead, is essential for successful document delivery aligned with sponsor timelines and goals.

Key Responsibilities:

• Develop Clinical Protocols and Investigator's Brochures

• Coordinate communication and meetings with stakeholders

• Manage cross-functional contributions and document review

• Interpret clinical data for clear regulatory documentation

• Ensure compliance with regulatory requirements

Requirements:

• Advanced degree in life sciences preferred

• Minimum 4 years regulatory medical writing experience

• At least 2 years as a medical writing project lead

• Expertise in clinical study reports and protocols

• Strong leadership and communication skills

Your leadership in regulatory writing will ensure efficient documentation and adherence to industry standards.
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