Senior Medical Writer

Principal Medical Writer

Lead the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Support clients’ submissions to regulatory authorities and ensure compliance with industry standards.

Responsibilities

• Guide medical writing document preparation, coordinate assignments, review, and provide substantive editing.
• Assume primary responsibility for the preparation of key regulatory response documents and major regulatory submissions.
• Formulate writing approach, develop timelines, and assess resource requirements for key documents and regulatory submissions within designated therapeutic or functional areas.
• Participate on relevant project teams and task forces, providing functional and cross‑functional guidance on document preparation, regulatory guidance, and guidance on content and format.
• Lead the writing strategy, including organizat...