Senior Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Overseeing the creation of high-quality and timely clinical study documents.

• Planning, drafting, editing, formatting, and conducting quality control reviews of clinical documents, which include clinical study protocols, Investigator Brochures (IBs), Informed Consent Form (ICF) templates, Development Safety Update Reports (DSURs), and Clinical Study Reports (CSRs).

• Ensuring efficient and effective document management in collaboration with sponsors, external vendors, and/or internal project teams.

• Independently distilling key messages from clinical study data.

• Composing complex content utilizing expertise and understanding of relevant processes.

• Communicating clearly and concisely in both written and verbal forms with internal and client teams.

• Contributing to the development and upkeep of medical writing processes, standard operating procedures (SOPs), templates, and work instructions.

⛳️ Requirements

• Bachelor's degree or equivalent in a scientific or medical field with relevant writing experience.

• Over 5 years of experience as a medical writer in a sponsor and/or Contract Research Organization (CRO) environment.

• Proficient in Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.

• Strong understanding of applicable regulations (e.g., ICH, FDA, GCP).

• Exceptional attention to detail and the ability to complete writing tasks promptly.

• Capability to work effectively in a fast-paced environment with multiple high-priority projects.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.