Medical Editor - U.S. Label & Launch Operations (Remote- US)

Medical Editor - U.S. Label & Launch Operations (Remote- US)

We are seeking a Medical Editor - U.S. Label & Launch Operations for a global pharmaceutical client. The focus of the role is to work on 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.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% Remote role in US

Hours: Mon-Fri 8am-5pm.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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
  
  

Requirements:

• 5+ years of experience as a medical editor

• 5+ 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

• 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

• Bachelor's Degree or equivalent

Please submit your resume to our network at (please apply to the Medical Editor - U.S. Label & Launch Operations (Remote- US) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $42.34hr. - $55.89/hr (Depending on location).

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