Medical Writer – Regulatory

Responsibilities

• Working with Medical Writing, revise documents for adherence to style guidelines, consistency, and submission compliance, including formatting, corrections, annotations, source verification, and all levels of QC and editing as applicable.
• Collaborate with Medical Writing and other clinical and regulatory team members in the preparation of clinical and regulatory documents; participate in the document-review process to consolidate comments and resolve conflicts.
• QC and edit manuscripts, abstracts, and other conference materials related to publications strategy.
• Contribute to timeline creation and adhere to review timelines.
• Verify, gather, and share literature references to library, gather and post literature for submissions, coordinate searches, and order articles as needed.
• Ensure applicable guidelines and regulations are followed in the scientific and clinical writing deliverables, including but not limited to the International Council for Harmonization (ICH), Common Technical Documents (CTD) guidelines, content, and templates, as well as QC documentation
• Assist with template modification or creation.
• Assist with development of Medical Writing standard operating procedures (SOPs) and policies, internal guides, project checklists, and training materials

Requirements

• Bachelor’s degree with 5+ years of related experience.
• M2 and M3 experience a must.