Medical Editor (Hybrid)

Cella by Randstad Digital; Lake Forest (IL); Presencial; USD 62 000 - 72 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health/vision/dental

401k

Resumo da oferta

Cella by Randstad Digital is seeking a Medical Editor for a 12-month W2 hourly contract with extension potential based on performance. You will oversee review, fact-checking, and e-approval workflows for promotional, non-promotional, and internal materials, supporting PRC meetings and FDA Ad Promo readiness.

The ideal candidate brings 3+ years in regulatory affairs or medical editing within a regulated life sciences environment, strong problem-solving skills, and a commitment to quality and

Qualificações

• 3+ years of experience in regulatory affairs or medical editing in pharma.
• Bachelor's degree in a technical or science discipline.
• Experience with FDA Ad Promo / OPDP submissions and electronic document management.

Responsabilidades

• Editorial Review & Fact-Checking: detailed reviews, QC, final reviews, and reapprovals for materials.
• Process & Workflow Management: manage review and approval lifecycle using electronic systems.
• FDA & OPDP Compliance Support: prepare submission packages and archive correspondence.
• Cross-Functional Collaboration: partner with Marketing Ops and attend PRC meetings.
• Departmental Improvement: contribute to SOPs and process improvements.

Conhecimentos

Regulatory affairs

Quality compliance

Medical editing

Formação académica

Bachelor's degree in technical or science related discipline

Ferramentas

EDMS

Descrição da oferta de emprego

Job Type: starts on a 12-month W2 hourly contract (extension/conversion based on performance)

Compensation Range: $45-52/hr

Benefits:

• health/vision/dental, 401k, and more (https://shorturl.at/GMPcb)

We are seeking a highly detailed and collaborative Medical Editor on behalf of our pharmaceutical client. In this role, you will oversee the review, fact-checking, and electronic approval workflows for promotional, non-promotional, and internal materials. Working closely with cross-functional teams and Marketing Operations, you will support Promotional Review Committee meeting discussions, ensure alignment with departmental SOPs, and prepare FDA Ad Promo (OPDP) submission packages and documentation.

The ideal candidate brings a background in medical editing within a regulated life sciences environment, strong independent problem-solving skills, and a commitment to maintaining quality and compliance across all material launches.

Responsibilities

• Editorial Review & Fact-Checking: Perform detailed editorial reviews, fact-checking, quality control (QC), final reviews, and reapprovals for promotional, non-promotional, and internal materials.
• Process & Workflow Management: Manage the review and approval lifecycle for all materials, utilizing electronic approval systems, administering user access/training, and routing items according to SOP grids.
• FDA & OPDP Compliance Support: Prepare FDA Ad Promo submission packages-including Form 2253 and cover letters-for Regulatory Operations publishing, and archive OPDP correspondence as directed.
• Cross-Functional Collaboration: Partner with Marketing Operations to prioritize approvals for routine requests, major campaign launches, and label updates; attend PRC meetings to address editorial queries.
• Departmental Improvement: Contribute to the creation and maintenance of departmental SOPs/work instructions and support broader process improvement initiatives.

Qualifications

• 3+ years of experience in regulatory affairs, quality compliance, or a related pharmaceutical domain.
• Bachelor's degree in technical or science related discipline or related work experience.
• Demonstrated background in medical editing and fact-checking of medical materials.
• Hands-on experience with medical/regulatory review and quality control (QC) processes.
• Familiarity with FDA Ad Promo / OPDP submission procedures and electronic document management systems.

Job ID: JN -102026-164992

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Cella, a randstad digital company, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Cella by randstad digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.