Our client, a leading pharmaceutical company, is hiring a Medical Editor, on a contract basis.
Job ID: 83479
Work Location:
100% Remote
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 company ambition to continue advancing the efficient and expeditious execution of subpart submissions strategy and operations.
Education/Experience:
- Bachelors Degree or equivalent
- Experienced medical editor with five years’ experience
- Expert in Adobe Acrobat Professional
- 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
- Experience in writing and/or editing professional promotional, med ed, or related materials
- Pharmaceutical experience required
Knowledge/Skills:
- Strong interpersonal communication skills
- Knowledge of medical/pharmaceutical terminology and federal regulations governing pharmaceutical advertising
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
Pay: Southeast $40-42/hour W2
Northeast: $44-46/hour W2
West: $53-55/hour W2