Medical Editor

Job Title: Medical Editor

Location: 100% Remote

Hours: Mon-Fri 8am-5pm

Position Summary:

The Medical Editor, U.S. Label & Launch Operations, Medical Editing, is responsible for working in the processes associated with FDA subpart submissions in the U.S. market. This role will execute on the subpart E/H submissions across therapeutic areas to ensure compliance with all FDA guidelines and is responsible for ensuring coherence across tactics of all brands.

The role works closely with the Brand Teams, Commercial Regulatory Affairs, Worldwide

Commercialization Excellence (WCEx) and the cross-functional teams on execution of all subpart submissions across various channels while providing compliance oversight.

The role reports to the Senior Manager, Label & Launch Operations, Medical Editing, and is part of a team responsible for the meticulous execution of subpart submissions across all active brands.

This is an important role within U.S. Commercialization Strategy & Operations Organization and key to Client’s ambition to continue advancing the efficient and expeditious execution of subpart submissions strategy and operations. Key Responsibilities:

Develop annotated reference packs for promotional materials, ensuring they meet FDA standards by adding reference annotations to PDFs – highlight and back annotate corresponding references – and ensure they are formatted for electronic submission (eCTD)

Research missing reference annotations and/or references

Ensure all materials are free from errors and up to standard

Drive to completion multiple projects under extremely tight deadlines

Assist in the documentation, maintenance, and improvement of SOPs and training programs for internal teams and external agencies

Attend meetings with regulatory, legal, and marketing stakeholders to align on timelines and project scope

Contribute to broader operational strategies, including launch planning and label updates

Translate complex medical information into patient-friendly language

Assist in the proofreading of package inserts, medication guides, brief summaries, and other labeling documents

Liaise with cross-functional teams to ensure alignment on business-critical planning

Manage projects through enterprise systems

Assist the Senior Manager with key initiatives

Qualifications & Experience:

Bachelor’s Degree or equivalent

Experienced medical editor with at least five years’ experience

Expert in Adobe Acrobat Professional

Minimum of five years of experience in FDA reference pack creation

Thorough understanding of pharmaceutical LMR review process

Expert in the review and editing of regulatory documents for clarity, consistency, and compliance with

FDA and internal standards

Expert in FDA Guidelines for Subpart E/H Submissions

Ability to focus on detailed, repetitious tasks for long periods

Flexibility in meeting strict deadlines

Strong interpersonal communication skills

Knowledge of medical/pharmaceutical terminology and federal regulations governing pharmaceutical advertising

Experience in writing and/or editing professional promotional, med ed, or related materials

Pharmaceutical experience required