Eversana1

Eversana1

Medical, Legal and Regulatory (MLR) Coordinator

Overland Park, KS, United States · Full-time

Sponsorship not specifiedDetected 23 days ago
Project ManagementExcelProcess ImprovementCustomer SupportFDA RegulatoryScientific WritingLeadershipCommunicationTime ManagementMicrosoft Office

About the role

  • The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to make sure advertising, promotional and non-promotional content is accurate, compliant, and ready to be published.
  • As part of the MLR team, the Medical, Legal and Regulatory (MLR) Coordinator is responsible for managing all the MLR processes for a dedicated client.
  • Our employees are tasked with delivering excellent business results through the efforts of their teams.

Responsibilities

  • Manages the end-to-end MLR process.
  • Verifies that materials are assigned to the appropriate review path. Rejects incomplete submissions and materials that are not review ready. Facilitates/documents discussion in live meetings.
  • QCs Final Document vs. Approved Document
  • Supports FDA 2253 submissions, or country specific regulatory submissions with MLR Regulatory Reviewer/Partner
  • Support the development of project plans
  • Support upload of materials into clients' review and approval platforms, including supporting annotating, anchoring references, etc.
  • Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them.
  • We are deliberate and self-reflective about the kind of team and culture we are building.
  • We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve.

Requirements

  • An individual in this position must be able to successfully perform the expectations listed above.
  • Must demonstrate excellent ability to communicate effectively in English, both orally and in writing.
  • Experience with use of Veeva Vault PromoMats / MedComms
  • Experience in Scientific Writing / Scientific Reviewing / MLR
  • Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications).
  • While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the
  • shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds.

Nice to have

  • Experience and/or Training
  • Ability to perform assignments with a high degree of independence requiring extensive experience, skill, and knowledge
  • Excellent computer skills including competency in presentation, word processing and spreadsheet software, utilizing MS Office Suite.
  • Familiar with laws and regulations regarding US drug / device advertising and promotion, including industry best practices
  • Must be quality-oriented and demonstrate consistent attention to detail.
  • Must have the ability to follow established processes and procedures and the flexibility to adopt new practices and priorities as required.
  • Positive Attitude and Energy - Exhibits an upbeat attitude, a genuine interest in others and a sense of humor.
  • Energizes others and heightens morale through her/his attitude.

Skills

  • The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

Compensation

  • Maintain and contribute toward process improvement which positively impacts metrics associated with activities of the MLR Review process; metrics are subject to change annually or more often as deemed necessary.

Benefits

  • We're fueled by our vision to create a healthier world.
  • Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry.
  • Support medical content development team

Company info

  • At EVERSANA®, we are proud to be a Great Place to Work across the globe.
  • Our global team of more than 6,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry.
  • We are grounded in our cultural beliefs and serve more than 670 clients ranging from innovative biotech start-ups to established pharmaceutical companies.
  • We are EVERSANA.

Equal opportunity

  • If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources.
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