Medical Writer (Life Sciences)

TL;DR

Medical Writer (Life Sciences): Creating, researching, and editing clinical documents for independent review and regulatory submissions with an accent on compliance with FDA/EMA guidelines and ICH-GCP. Focus on authoring clinical data forms, managing client communications, and ensuring document integrity across the project lifecycle.

Location: Remote (US). Candidates located in AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred.

Salary: $65,305–$93,000

Company

hirify.global helps the global biopharmaceutical industry bring new, advanced medical treatments to market faster through expert clinical research support.

What you will do

• Develop and finalize clinical documents, including charters, data forms, and reviewer training materials for regulatory submission.
• Act as the primary client contact for medical writing projects, negotiating timelines and resolving project issues.
• Conduct literature searches and research to obtain background information for document development.
• Coordinate interdepartmental reviews and ensure documentation adheres to FDA/EMA or other regulatory guidelines.
• Provide medical editing and copyediting review for documents prepared by other writers.
• Manage stakeholder engagement and implement communication plans to ensure project success.

Requirements

• Bachelor's Degree in a technical discipline (Science, pharmacy, nursing, or other health-related field).
• Must be based in the United States.
• Solid professional experience in a medical writing role within a CRO, pharmaceutical, or biotechnology firm.
• Deep understanding of industry guidelines and regulations, specifically ICH-GCP.
• English: Fluent (C1) written and verbal communication skills required.
• Proven proficiency with Microsoft Office products (Word, Excel, PowerPoint).

Nice to have

• Understanding of Agile methodologies.
• Proficiency in a non-English language (written and verbal).
• Experience using tools to communicate progress to stakeholders.

Culture & Benefits

• Medical, Dental, and Vision benefits for employees and their families, including FSA and HSA.
• Comprehensive wealth package including 401(k), life, accident, and disability insurance.
• Paid time off policy covering holidays and sick leave.
• Access to internal growth and development programs and professional trainings.
• Inclusive workplace as an Equal Employment Opportunity employer.