Senior Medical Writer - Remote

Overview

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas.

In Short

• Write content for clinical documents in various therapeutic areas.
• Track writing projects and adhere to regulatory guidelines.
• Serve as lead for a compound and review work of junior writers.
• Participate in document development meetings.
• Explain complex medical concepts to a lay audience.
• Ensure compliance with internal guidelines and SOPs.
• Strong organizational and communication skills required.
• Manage multiple projects effectively.
• Mentor junior staff as needed.
• Contribute to process improvement initiatives.

Requirements

• Bachelor's degree required (advanced degree preferred).
• Minimum of 3 years of relevant Medical Writing experience.
• Knowledge of biostatistics and clinical research process.
• Experience with clinical document writing and editing.
• Proficient in MS WORD, Adobe Acrobat, and electronic document systems.
• Familiarity with ICH GCP guidelines.

Benefits

• Health and wellness programs.
• Access to fitness centers.
• Equity awards and annual bonuses.
• Paid time off for eligible employees.
• Inclusive and diverse culture.