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    Senior Medical Reviewer

    Novo Nordisk
    2+ years
    Not Disclosed
    Bangalore
    10 Nov. 11, 2024
    Job Description
    Job Type: Full Time Remote 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 Title: Senior Medical Reviewer, Centralized Monitoring Unit (CMU)

    Location: Bangalore, India
    Company: Novo Nordisk

    About the Department:

    The Centralized Monitoring Unit (CMU) at Novo Nordisk is a key part of the Clinical Drug Development division, offering a dynamic and collaborative work environment. This department is a unique combination of skilled medical professionals and technical experts, including Medical Reviewers, Functional Programmers, and Statistical Monitors, all working together to ensure the safety and efficacy of clinical trials. As part of a global team, you will contribute to proactive monitoring efforts by identifying and addressing clinical risks, enhancing patient safety, and ensuring compliance with Good Clinical Practice (GCP) and regulatory guidelines.

    Position Overview:

    The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across multiple therapeutic areas within Novo Nordisk’s drug development portfolio. This role is integral to maintaining high standards for data integrity, patient safety, and regulatory compliance. The Senior Medical Reviewer will work closely with the clinical trial team, including Data Managers, Trial Managers, and Medical Specialists, to ensure accurate and timely medical reviews, as well as identifying and resolving medical issues during the trial process. This position is critical in ensuring that clinical trials maintain the highest standards of safety and protocol adherence.

    Key Responsibilities:

    • Medical Review & Data Quality Assurance:

      • Conduct thorough medical reviews of clinical trial data to ensure compliance with protocols, GCP, ICH guidelines, and local regulations.
      • Identify inconsistencies and clinically significant outliers in the data, escalating issues for resolution.
      • Collaborate with site teams to clarify and resolve medical concerns and data discrepancies in real time.

    • Collaboration & Stakeholder Engagement:

      • Work closely with Data Managers, Trial Managers, and Medical Specialists to ensure the highest level of trial integrity and safety.
      • Present medical findings to relevant stakeholders, providing critical insights that support decision-making throughout the trial.
      • Provide training and guidance to new team members, ensuring alignment on medical review processes.

    • Trial Planning & Process Improvement:

      • Contribute to trial planning activities, particularly in relation to medical review and monitoring requirements.
      • Ensure medical monitoring displays and data listings are optimized for efficient and accurate reviews.
      • Lead quality checks to ensure medical reviews are thorough and in line with protocol and regulatory expectations.

    • Documentation & Reporting:

      • Document all medical reviews within the Trial Master File (TMF), maintaining thorough and accurate records of findings and actions taken.
      • Provide timely updates on the status of medical reviews to study teams and escalate issues as necessary.

    • Continuous Improvement:

      • Promote and implement process improvements to enhance the efficiency and effectiveness of medical reviews.
      • Contribute to the development of best practices and standard operating procedures (SOPs) related to medical review processes.

    Qualifications:

    • Education:

      • Graduate degree in Medicine or a related field is required (MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical fields with relevant clinical research experience also considered).

    • Experience:

      • 3-5 years of relevant experience in Clinical Drug Development (e.g., Medical Data Review, Medical Monitoring, Safety Surveillance).
      • At least 1-2 years of project management experience is essential.
      • Experience in clinical trial processes, including knowledge of medical terminology and trial protocols.

    • Skills & Competencies:

      • Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice).
      • Proficient in MS Office, MS Project, and PowerPoint.
      • Strong analytical skills and a results-driven approach to medical data review.
      • Exceptional proficiency in written and spoken English.
      • Ability to collaborate effectively with multidisciplinary teams and communicate complex medical data clearly.

    Working at Novo Nordisk:

    Novo Nordisk is a leading global healthcare company with over 100 years of experience in tackling chronic diseases. As a leader in diabetes care and other therapeutic areas, Novo Nordisk impacts the lives of millions of patients worldwide. With more than 63,000 employees globally, we believe in the power of collaboration, diverse perspectives, and fostering an inclusive culture. At Novo Nordisk, you will be part of a team that is dedicated to changing lives.

    Application Deadline:

    Applications are accepted until November 20th, 2024. However, the position may close earlier depending on the volume of applications. Please submit your application via our careers website.

    Commitment to Inclusion:

    Novo Nordisk is committed to an inclusive recruitment process and provides equal opportunity to all applicants. We celebrate the diversity of our employees, the patients we serve, and the communities in which we operate. We encourage individuals from diverse backgrounds to apply.

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