Medical Information Specialist (Medical Writing)

TL;DR

Medical Information Specialist (Medical Writing): Authoring, preparing, and QC'ing regulatory and safety documents with an accent on compliance to global standards, FDA, ICH, and GCP guidelines. Focus on ensuring accuracy, relevance, and consistency of data in clinical documents while managing their entire lifecycle.

Location: Onsite in New Jersey (US) or Mexico

Company

hirify.global is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready.

What you will do

• Author and prepare regulatory/safety documents, incorporating review comments and coordinating QC processes.
• Perform peer and QC reviews to validate data accuracy, relevance, and consistency against source data and style guides.
• Assist senior medical writers with complex deliverables and manage document lifecycle ensuring quality and timeliness.
• Format Word and PDF documents, including TOC, abbreviations, tables, figures, cross-referencing, pagination, and hyperlinking.
• Ensure clinical documents adhere to global standards, FDA, ICH, and GCP guidelines.
• Interface regularly with clients and ensure compliance with quality, confidentiality, and security.

Requirements

• Minimum 2 years of experience in medical writing or equivalent in life sciences.
• Medical/M.Pharm/Pharm D/life sciences degree.
• Knowledge of regulatory documentation, drug development process, and global regulations/guidelines.
• Proficiency with document management systems, Excel, and Outlook.
• Good written and verbal communication skills.
• Good organizational, time management, attention to detail, and decision-making skills.

Culture & Benefits

• Fast-track career growth at the intersection of healthcare and technology.
• Mentorship from brilliant minds in the industry.
• Purpose-driven culture focused on customer obsession, boldness, nimbleness, and industriousness.
• Global growth opportunities.