Senior Medical Writer

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

📋 Description

• Oversee the creation of high-quality clinical study documents delivered on schedule.

• Plan, write, edit/format clinical documents, and conduct quality control reviews.

• Develop documents in alignment with Precision MW Style Guide, Precision SOPs, relevant regulatory guidelines (such as ICH, FDA, GCP), and eCTD requirements.

• Ensure efficient document management from inception to final approved version, collaborating with Sponsors, external vendors, and/or internal Precision project teams/departments.

• Capable of independently extracting key messages from clinical study data.

• Assist in the creation and upkeep of medical writing processes, SOPs, templates, and work instructions for essential documents.

• Conduct literature-based research to support writing tasks.

⛳️ 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 either a sponsor or CRO environment.

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

• Strong understanding of applicable regulations (e.g., ICH, FDA, GCP), clinical trial transparency requirements (such as EudraCT, CT.gov), and eCTD requirements across all development phases.

• Exceptional attention to detail and the capability to complete writing assignments punctually.

• Ability to thrive in a fast-paced environment with numerous high-priority projects, requiring minimal guidance on routine tasks and limited instruction on new assignments.

🏝️ Benefits

• This position is eligible for a discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.