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Medical Content And Review Specialist

2+ years
Not Disclosed
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Medical Content and Review Specialist at EVERSANA 🌍

At EVERSANA, we are proud to be certified as a Great Place to Work globally. Our vision is to create a healthier world, and we do so through our global team of over 7,000 employees. We serve more than 650 clients, from innovative biotech start-ups to established pharmaceutical companies, delivering next-generation commercialization services to the life sciences industry. Join us to help improve the lives of patients around the world!

Position: Medical Content and Review Specialist
Location: Remote
Department: Clinical & Medical
Job Family: Medical & Regulatory Affairs
Travel: 0%
Hours: Full-time


Job Description

As a Medical Content and Review Specialist, you will be responsible for managing the Medical, Legal, and Regulatory (MLR) review process. This process ensures that all promotional and non-promotional content is accurate, compliant, and ready to be published. Your role will involve overseeing the review process for a dedicated client, coordinating meetings, and supporting the development of medical content.

Key Responsibilities:

  • Manage the end-to-end MLR process for assigned clients.
  • Lead and schedule Review Committee meetings, ensuring all materials are reviewed in line with compliance standards.
  • Support the development of project plans and medical content.
  • Utilize tools like Veeva Vault PromoMats and Vault MedComms to facilitate document reviews and approvals.
  • Ensure all materials are properly vetted and meet the necessary compliance standards.
  • Support FDA 2253 submissions and regulatory review processes.
  • Provide project management support to Medical Affairs and Medical Information teams.
  • Assist with quality control and process improvements in the review system.

Expectations:

  • Metrics & Performance: Contribute to process improvements and maintain key performance metrics.
  • Customer Service: Maintain high customer service standards in the MLR review process.
  • Time Management: Effectively prioritize and manage multiple tasks to meet deadlines.

Education and Experience:

  • Required: Bachelor's degree in any Life Sciences or Biomedical field.
  • At least 2 years of experience in a healthcare agency or pharmaceutical company.
  • Familiarity with Veeva Vault PromoMats and MedComms platforms.
  • Experience with Scientific Writing/Scientific Reviewing and MLR processes.
  • Strong project management, time management, and meeting management skills.
  • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).

Preferred Qualifications:

  • Degree: Graduates/Post-graduates in Pharmacy or Medicine.
  • Knowledge of global healthcare compliance statutes and regulations.
  • Ability to manage cross-functional projects and multiple deadlines.
  • Familiarity with US drug/device advertising regulations.
  • Knowledge of medical terminology (preferred).

Our Cultural Beliefs:

  • Patient Minded: Act with the patient’s best interest in mind.
  • Client Delight: Own every client experience and its impact on results.
  • Take Action: Empower yourself and hold yourself accountable.
  • Embrace Diversity: Create an environment of awareness and respect.
  • Grow Talent: Invest in your own development and others’ growth.
  • Win Together: Collaborate to achieve results.
  • Communication Matters: Engage in transparent, timely dialogue.
  • Always Innovate: Be bold and creative in everything you do.