Medical Writer I

The Opportunity :

A Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.

Roles & Responsibilities :

Primarily works at a project level.

Writes and edits clinical regulatory documents including study reports, protocols, briefing books, investigator’s brochures, health authority responses, and other submission documents (e.g., module 2.5 and modules 2.7.x).

Compiles, analyzes, and summarizes data from various sources.

Conducts proofreading, editing, document formatting, and comment resolution.

Ensures documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical / scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.

May participate in the preparation / revision of document templates and SOPs.

May train and support medical writers or external vendors / contractors on document planning, processes, and content development.

Experience & Qualifications :

Bachelor's, Master's, MD, PhD, PharmD in life sciences (or other related field).

Preferred Master's, MD, PhD, PharmD.

University degree with a minimum of 5+ years of relevant experience; advanced degree preferred.

Proficient as lead author writing protocols / protocol amendments, clinical study reports, investigator’s brochures, and clinical summary documents (modules 2.5 and 2.7.1-2.7.4)

6+ years with an advanced degree.

Travel Requirements :

Up to 10%