Victory Healthcare Communications · 2 months ago
Freelance Regulatory Submissions Specialist (Pharma Marketing)
Basking Ridge, NJ
Full-time
Onsite
Entry, Mid Level
$40/hr - $50/hr
1+ years expVictory Healthcare Communications is seeking a highly skilled and detail-oriented Freelance Regulatory Submissions Specialist to join their agency team on a freelance contract basis. The role involves managing the submission process for pharmaceutical products, ensuring compliance with regulatory requirements, and timely submissions to health authorities.
AdvertisingConsultingHealth CareMarket ResearchPersonal Branding
Responsibilities
Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Medical Writing to gather necessary documentation for submissions
Ensure all submitted documents meet regulatory standards and guidelines (AMA 11 style and brand standards)
Prepare submission packages according to specific health authority requirements
Conduct quality checks on submission documents for accuracy and completeness
Maintain up-to-date knowledge of relevant regulations and guidelines related to drug submissions
Keep track of submission timelines and ensure timely delivery of submissions
Assist in resolving any issues or queries related to submissions from health authorities
Prepare files for submission into Veeva Vault PromoMats or similar platforms
Incorporate feedback from Medical, Legal, and Regulatory (MLR) reviews with speed and accuracy
Annotating and fact-checking materials, ensuring claims are supported by cited sources
Qualification
Required
At least 1–3 years proven experience as a Submissions Specialist within the pharmaceutical/pharma marketing industry
Knowledge of FDA regulations pertaining to drug development and submissions is essential
In-depth knowledge of MLR review processes using platforms like Veeva PromoMats with a clear understanding of compliance standards (ISI, fair balance, FDA promo review, etc.)
Strong attention to detail with excellent organizational skills
Ability to work effectively in cross-functional teams under tight deadlines
Proficiency with Veeva CRM and PromoMats
Expertise working in an Apple/Macintosh computer environment, as well as Apple software
Expertise working in Adobe Acrobat
Expertise working in Veeva PromoMats
Knowledge of Microsoft Office Suite (Excel, PowerPoint, Word, Sharepoint, Teams, Copilot)
Knowledge of Google Workspace (Calendar, Sheets, Slides, Docs, Meet, and Gmail)
Preferred
Proofreading experience is a plus!
Experience with Monday.com project management tools is a plus
Company
Victory Healthcare Communications
Victory Healthcare Communications is a medical advertising agency.
11-50 employees
Funding
Current Stage
Early StageRecent News
Buffalo Business First
2025-03-01
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