Senior Medical Writer

The Senior Medical Writer will lead the development of high-quality clinical study documents, ensuring compliance with regulatory guidelines and internal standards. The role requires expertise in clinical documentation, regulatory requirements, and collaboration with internal and external teams.

Location: Not specified, likely remote or on-site at company discretion

Salary: $100,600—$151,000 USD

Responsibilities

• Planning, writing, editing, formatting, and QC review of clinical documents including protocols, IBs, ICF templates, DSURs, CSRs, patient narratives.
• Ensuring smooth document management from template to final version in collaboration with sponsors, vendors, and internal teams.
• Formulating key messages from clinical data independently.
• Authoring complex content with understanding of processes.
• Communicating clearly in writing and verbally with teams.
• Contributing to development and maintenance of medical writing processes, SOPs, templates, and work instructions.
• Performing literature-based research to support writing activities.
• Other duties as assigned.

Requirements

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
• 5+ years of experience as a medical writer in sponsor and/or CRO setting.

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation

Additional Information

• The role is eligible for a salary range of $100,600—$151,000 USD.
• The position requires proficiency with Microsoft Office, Adobe Acrobat, and understanding of regulatory guidelines (ICH, FDA, GCP), clinical trial transparency, and eCTD requirements.
• Preferred candidates may have an advanced degree (MS/PhD) and experience in oncology or rare diseases.