The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Content Management - Medical Editor in for a remote opportunity

Role Description

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 Bristol Myers Squibb’s ambition to continue advancing the efficient and expeditious execution of subpart submissions strategy and operations.
• 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

Skills & Requirements

• 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

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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