Medical Content and Review Specialist

Summary

Join EVERSANA as a Medical Content and Review Specialist and manage the end-to-end Medical, Legal, and Regulatory (MLR) review process for a dedicated client. You will be responsible for scheduling and leading review committee meetings, ensuring compliance with internal and external policies, and utilizing online review systems like Veeva Vault. This home-office based role requires excellent communication skills, experience with Veeva Vault, and a life sciences background. The position demands strong project management, time management, and customer service skills. You will support medical content development and collaborate with cross-functional teams. Flexibility to work US hours is required.

Requirements

• Graduates in any Life Sciences / Biomedical field
• Must demonstrate excellent ability to communicate effectively in English, both orally and in writin
• At least 2 years of experience in a healthcare agency or pharmaceutical company
• Experience with use of Veeva Vault PromoMats / MedComms
• Experience in Scientific Writing / Scientific Reviewing / MLR
• Project management
• Time management
• Meeting management
• Excellent customer service skills
• Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications)

Responsibilities

• Manages the end-to-end MLR process
• Responsible for scheduling, setting the agenda, and leading Review Committee meetings
• Add live discussion notes for comments discussed in Veeva Vault
• Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize and file approved minutes
• Ensure all covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault PromoMats and Vault MedComms)
• Cascade and enforce any new policies and guidelines related to review of materials
• 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
• Helps establish and/or update MLR SOPs
• Support the development of project plans
• Support medical content development team
• Support upload of materials into clients’ review and approval platforms, including supporting annotating, anchoring references, etc
• Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
• All other duties as assigned
• 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
• Maintain and improve customer services associated with the activity of the MLR review
• Complete MLR coordination responsibilities in a timely manner
• Able to work full-time and be flexible with work scheduling as required by clients and management

Preferred Qualifications

• Graduates/Postgraduates in Pharmacy or Medicine preferred
• Working knowledge of or familiarity with global healthcare compliance statutes and laws
• 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
• Proven ability to manage multiple tasks, set priorities, and meet deadlines
• Ability to manage cross-functional projects
• Familiar with laws and regulations regarding US drug/device advertising and promotion, including industry best practices
• Knowledge of medical terminology (preferred but not required)
• 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
• Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and create a climate that motivates and encourages others to participate
• Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance
• Highly Principled – Proves to be a professional of unquestionable integrity, credibility, and character who demonstrates high moral and ethical behavior