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    Medical Content And Review Specialist

    Eversana
    2+ years
    Not Disclosed
    Pune
    10 Dec. 12, 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

    Company Overview:

    At EVERSANA, we are proud to be certified as a Great Place to Work globally. Our vision to create a healthier world drives us forward, with a team of over 7,000 employees dedicated to providing next-generation commercialization services to the life sciences industry. We serve more than 650 clients, ranging from innovative biotech startups to established pharmaceutical companies. Our products, services, and solutions help bring groundbreaking therapies to market and support the patients who rely on them. Together, we make an impact every day.

    We are committed to cultivating a diverse and inclusive workplace. Improving patient lives is our priority, and we believe that individuals from all backgrounds are essential in shaping the future of healthcare. We look for team members who are not only skilled but also passionate about EVERSANA’s mission, our people, clients, and most importantly, the patients we serve. We are EVERSANA.

    Position: Medical Content and Review Specialist
    Location: [Insert Location]
    Job Type: Full-time

    Job Description:

    The Medical Content and Review Specialist plays a critical role in the Medical, Legal, and Regulatory (MLR) review process, ensuring that all advertising, promotional, and non-promotional content is accurate, compliant, and ready for publication. This role manages the end-to-end MLR process, providing administrative and program management support for the client’s MLR operations.

    Key Responsibilities:

    • End-to-End MLR Process Management: Lead and manage the entire MLR process for a dedicated client, ensuring all communications are vetted and compliant.
    • Review Committee Management: Schedule and lead Review Committee meetings, including adding live discussion notes in Veeva Vault and managing meeting minutes.
    • Quality Control: Verify that all materials are assigned to the appropriate review path, reject incomplete or unreview-ready submissions, and ensure compliance with internal and external policies.
    • Documentation: Maintain accurate records of all approved documents, support FDA 2253 submissions, and QC final documents against approved versions.
    • Content Support: Assist in the development of project plans, support medical content development teams, and upload materials into review and approval platforms (e.g., Veeva Vault).
    • Project Management: Support Medical Affairs and Medical Information leadership in managing key initiatives and project plans.

    Job Expectations:

    • Metrics: Contribute to process improvements that enhance metrics related to the MLR review process.
    • Customer Service: Provide exceptional customer service and ensure timely completion of MLR coordination responsibilities.
    • Time Management: Effectively manage time to meet deadlines and adjust to client needs.
    • Travel: Typically, this position does not require travel.

    Qualifications:

    • Education: Degree in Life Sciences/Biomedical field; Post-graduate education in Pharmacy or Medicine preferred.
    • Experience: At least 2 years of experience in a healthcare agency or pharmaceutical company, including familiarity with Veeva Vault PromoMats and MedComms.
    • Skills: Strong experience in scientific writing, reviewing, MLR processes, and project management. Must have excellent communication and customer service skills.
    • Technology: Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

    Preferred Qualifications:

    • Familiarity with global healthcare compliance statutes and laws.
    • Ability to manage cross-functional projects and meet deadlines.
    • Knowledge of US drug/device advertising and promotion regulations.
    • Familiarity with medical terminology (preferred but not required).
    • High attention to detail, quality-oriented, and adaptable to changing priorities.
    • Positive attitude, excellent communication, and innovation-driven mindset.

    Fraud Prevention Notice:

    Be cautious of fraudulent job offers misrepresenting EVERSANA. We will never ask for personal information or payment during the hiring process. If you encounter suspicious offers, please report them immediately.

    Diversity, Equity, and Inclusion:

    EVERSANA is proud to be an Equal Opportunity Employer. We believe that diversity is key to our success, and we foster an inclusive environment where all perspectives are valued. Diversity encompasses race, gender, age, disability, veteran status, sexual orientation, religion, and more. Inclusion is everyone’s responsibility, and all viewpoints are critical to improving the lives of patients and leading healthcare innovation.

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    Warsaw |

    Remote :

    Tulsa | Melbourne | Bishop | Nairobi | Zaragoza | Texas | Remote | Blue Bell | Lousiana | Lenexa | Medan | Minnesota | French | Hammond | Leinster | Switzerland | Castlebar | Hungary | Belgium | Remote - Middle East | Slovakia | Remote - Europe | McFarland | Manipal | Thailand | Remote - Africa | Green Way | Ireland | Springville | Bountiful | Remote, USA | Remote - South America (Latin Americal) | Xzagreb | Riga | Faridabad | Victoria |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | Jeddah | Khulais | Najran | King Abdullah Economic City | Rabigh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |