Description

Coordinate medical writing activities and manage timelines for pharmaceutical deliverables. This role is on-site.

Responsibilities

• Develop and maintain medical writing SOPs and operational procedures.
• Represent the medical writing function during bid defenses and internal meetings.
• Implement sponsor-related style guides and client report templates.
• Participate in proposal preparation and resource allocation.
• Write Clinical Study Reports (CSR) and manage regulatory submissions.

Required Skills

• 8+ years of medical writing experience within the pharmaceutical or CRO industry.
• 8+ years of oncology writing experience across all clinical phases.
• 8+ years of experience with FDA and other regulatory submissions.
• Proven experience writing Clinical Study Reports (CSR).
• Familiarity with relevant ICH and FDA guidelines.
• Advanced Microsoft Word skills, specifically with complex tables.
• Strong analytical, problem-solving, and data interpretation skills.
• Direct experience with client interaction.
• Strong prioritization and organizational skills.

Preferred Skills

• Bachelor’s degree in biological sciences or an equivalent field.

Key Skills

Education

ANY GRADUATE