Promotional Review Editor- Pharma (Hybrid- Lawrenceville/Madison, NJ) Job at Sta
Stage 4 Solutions, Lawrence Township, NJ, United States
Promotional Review Editor- Pharma (Hybrid- Lawrenceville/Madison, NJ)
Promotional Review Editor- Pharma (Hybrid- Lawrenceville/Madison, NJ)
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Promotional Review Editor- Pharma (Hybrid- Lawrenceville/Madison, NJ)
We are seeking a Promotional Review Editor- Pharma for a global pharmaceutical client. The focus of the role is to work within the MLR process to ensure material is high quality, compliant, and meets customer needs This is a review-based job that prioritizes accuracy and speed to meet the demands of the business. All pharmaceutical advertising and promotion must be medically accurate and comply will all laws and regulations. Material must be approved through a Medical, Legal and Regulatory (MLR) review process before it can be used.
This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite role in Lawrenceville or Madison, NJ
This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.
Responsibilities
There are three primary responsibilities of the Promotional Review Editor:
- Complete an editorial review of promotional and internal materials for accuracy, quality and compliance
- Perform a Comment Verification (CV) on documents to ensure MLR advice has been incorporated correctly
- Facilitate live meetings where MLR advisors review materials and provide risk assessment to commercial and medical colleagues, capturing decisions and other annotations in an online routing system (Veeva Vault PromoMats)
- Review both promotional and internal materials for clarity and accuracy using Veeva PromoMats, our document management system
- Ensure materials align to style guide guidelines, company policies and regulatory requirements
- Ensure document submitted for MLR review align with FDA submission standards
- Assist Medical, Legal and Regulatory colleagues with reviews when needed
- Assist with FDA Submissions (2253 and accelerated approval) when needed
- Ensure MLR advice is incorporated and agreed upon with marketing Champions
- Triage advisor comments with commercial and medical colleagues
- Ensure materials are ready to be Approved for Distribution (AFD) and are submitted to FDA on Form 2253 or accelerated approval submissions
- Facilitate discussion of promotional and internal materials
- Capture live comments from MLR Advisors in Veeva PromoMats
- Help commercial and medical colleagues navigate the MLR review process
- 1+ years of proofreading experience or copy editing is preferred.
- Experience with Veeva PromoMats or MLR review.
- Experience in medical or pharma is preferred.
- Familiarity with regulatory affairs, specifically with FDA, OPDP, 2253 submissions preferred, but not required
- BS required (English, Communications, Business or Marketing is preferred)
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: $20/hr. - $24.55/hr.
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