Guillermo Carreon
Regulatory Specialist in Life Sciences
- Role
- Senior Mlr Submission Specialist at Indegene
- Location
- Whittier, CA, US
- LinkedIn followers
- 500 followers
About Guillermo Carreon
Highly motivated, detail-oriented bilingual Regulatory Specialist with both…
Experience
Senior Mlr Submission Specialist
Sep 2021 — Present
Ensures pharmaceutical marketing materials are successfully guided through the client’s internal review process,(Regulatory, Legal, Medical Communications, and Medical review) and approved for use by their deadline while aligning the materials to comply with FDA compliance and submission standards Prepares hundreds of pharmaceutical advertising, promotional and non-promotional communication to ensure MLR (Medical, Legal and Regulatory) reviewers have a clear understanding of updates, functionality and other information pertinent to their review Conducts file standard and submission process trainings to ensure company awareness of process and to assist with onboarding employees. Quality control checks submission documents to ensure they comply with document file standards and references are consistent with AMA/ APA guidelines Provides file standard guidance to project managers, account managers, and client marketing managers during project meetings and throughout the approval process to resolve compliance issues, guide them through the regulatory process, and ensure proper submission within the client’s documentation system (Veeva Vault PromoMats).
Skills
- Fundraising
- Proposal Writing
- Event Planning
- Leadership
- Public Speaking
- Non-Profits
- Editing
- Microsoft Office
- Nonprofits
- Project Planning
- Administrative Assistants
- Entrepreneurship
- Budgets
- Community Outreach
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