Guillermo Carreon Email & Phone Number

Highly motivated, detail-oriented bilingual Regulatory Specialist with both pharmaceutical advertisement and project management. Excellent analytical and critical thinking skills. Outstanding ability to collaborate with teams on projects and to manage deadlines. Skilled with multitasking and handling complex projects. Proven track record of managing major event operations. Experienced at conducting trainings and running meetings Core Competencies include eight years of program/ event coordination, several years of academic writing experience (grad/ undergrad), a year of business to business sales, and a 8 years of administrative contract experience. Specialties: Microsoft Office, Event Planning, Program Coordination, Administrative Assistance, Public Speaking, Editing, Writing, Microsoft PowerPoint, Basecamp, Excel, Word, Publisher, Outlook Express, Donor Perfect, Lotus Notes, EMS, BluePay, Adobe Connect, Blackboard

Listed skills include Event Planning, Nonprofits, Public Speaking, Editing, and 10 others.

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  Senior Mlr Submission Specialist

  Indegene

  Sep 2021 - Present - Remote

  ✓ 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).