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    Medical Content And Review Specialist

    Eversana
    2+ years
    Not Disclosed
    Pune
    10 Dec. 5, 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 Description
    At EVERSANA, we’re honored to be recognized as a Great Place to Work globally. Our mission is to create a healthier world, powered by over 7,000 employees committed to delivering next-generation commercialization services to the life sciences industry. We support over 650 clients, from innovative biotech startups to established pharmaceutical companies, helping bring groundbreaking therapies to market and improving the lives of patients who rely on them. Together, we make an impact every day—join us in our mission!

    Diversity is at the core of our success, and we believe in embracing different backgrounds and experiences to build the future of healthcare and life sciences. We foster an inclusive culture where each individual’s unique skills and perspectives make a difference. We seek team members who not only excel in their areas of expertise but who also care deeply about EVERSANA, our people, clients, and, most importantly, the patients we serve. We are EVERSANA.

    Job Description
    The Position
    The Medical, Legal, and Regulatory (MLR) review process is crucial to ensure that all healthcare advertising, promotional, and non-promotional content is accurate, compliant, and publication-ready. The Medical Content and Review Specialist plays a key role in managing the MLR process for a dedicated client, ensuring compliance with internal and external regulations and policies, and providing essential administrative and program management support.

    Essential Duties and Responsibilities

    • Medical Content and Review Specialist Responsibilities

      • Oversee the end-to-end MLR process.
      • Schedule, set agendas, and lead Review Committee meetings.
      • Take live discussion notes in Veeva Vault and document meeting minutes.
      • Ensure materials undergo proper review through the online system (e.g., Veeva Vault PromoMats and Vault MedComms).
      • Enforce policies and guidelines related to material review.
      • Verify the appropriate review path is assigned to materials.
      • Reject incomplete submissions and materials not ready for review.
      • Manage documentation and quality control of final documents.
      • Support FDA 2253 submissions with the MLR Regulatory Reviewer/Partner.

    • Medical Content Support Responsibilities

      • Assist in the development of project plans and support the medical content development team.
      • Help upload materials into client review platforms, including annotating and anchoring references.

    • Medical Affairs and Medical Information Project Management Support

      • Assist Medical Affairs leadership in managing key initiatives and project plans.
      • Perform other duties as assigned.

    Expectations of the Job

    • Metrics: Contribute to improving MLR review processes and metrics.
    • Customer Service: Maintain high customer service standards for MLR activities.
    • Time Management: Ensure timely coordination and completion of MLR responsibilities.
    • Hours: Flexible working hours as required by client needs.
    • Travel: This position does not require travel.

    Qualifications
    Minimum Knowledge, Skills, and Abilities

    • Education: A degree in Life Sciences or Biomedical fields.
    • Communication Skills: Strong proficiency in both oral and written English.
    • Experience: At least 2 years of experience in a healthcare agency or pharmaceutical company.
    • Skills:
      • Proficient in using Veeva Vault PromoMats / MedComms.
      • Experience in scientific writing and reviewing, MLR processes, and project management.
      • Strong customer service skills and proficiency in MS Office Suite.

    Preferred Qualifications

    • Education: Degree or postgraduate qualification in Pharmacy or Medicine.
    • Experience: Familiarity with global healthcare compliance laws and regulations.
    • Skills:
      • Ability to manage multiple tasks and set priorities effectively.
      • Knowledge of US drug/device advertising laws.
      • Familiarity with medical terminology (preferred).
      • Positive attitude, energy, and strong communication skills.

    Additional Information
    Our Cultural Beliefs

    • Patient Minded: I act with the patient’s best interest in mind.
    • Client Delight: I own every client experience and its impact on results.
    • Take Action: I am empowered and hold myself accountable.
    • Embrace Diversity: I create an environment of awareness and respect.
    • Grow Talent: I own my development and invest in the development of others.
    • Win Together: I passionately connect with anyone, anywhere, anytime to achieve results.
    • Communication Matters: I speak up to create transparent, thoughtful, and timely dialogue.
    • Always Innovate: I am bold and creative in everything I do.

    Diversity, Equity, and Inclusion
    At EVERSANA, Diversity, Equity, and Inclusion are central to our success. We are an Equal Opportunity Employer and value employees from various backgrounds and experiences. Diversity is about more than just race or gender—it also includes age, disability, sexual orientation, religion, and many other facets of identity. Inclusion is everyone’s responsibility, and all perspectives are vital to our collective success.

    Please Note
    Beware of fraudulent job offers misrepresenting EVERSANA. We will never ask for personal information or require payment for training or job applications. Always verify the authenticity of job offers.

    Join us at EVERSANA and help us drive innovation to improve patient outcomes.

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    Lombardy :

    Rho |

    Japan :

    Japan | Saitama |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    New Zealand :

    New Zealand |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

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

    Bucharest :

    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | Argentina |

    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 |