Senior Medical Writer/Principal Medical Writer

📋 Description

• Lead development of clinical study documents with on-time delivery.
• Plan, write, edit, format, and QC documents per guidelines.
• Ensure documents meet ICH, FDA, GCP, and eCTD requirements.
• Manage templates, versions, and approvals with sponsors/teams.
• Formulate key messages from clinical study data for MW output.
• Contribute to MW processes, SOPs, templates, and training.

🎯 Requirements

• BS degree or equivalent in science/medical field with writing exp.
• 5+ years as Sr. Medical Writer or 7+ years as Principal.
• Advanced degree (MS/PhD) preferred.
• Proficient with Word, Excel, PowerPoint, Acrobat, Teams.
• Knowledge of ICH, FDA, GCP, eCTD, CT.gov/EudraCT.
• Ability to handle multiple high-priority projects in fast-paced settings.

🎁 Benefits

• Remote work options where applicable.
• Equal Opportunity Employer.
• Reasonable accommodation for applicants with disabilities.
• Privacy policy and CA privacy notice available.