Regulatory Medical Writing jobs in Bengaluru, Karnataka

Medical Data Reviewer - Remote, Home-Based

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Medical Data Reviewer at ICON, you will provide expert medical oversight of clinical trial data, ensuring accuracy, consistency, and patient safety. You will support complex programmes, mentor colleagues, and contribute to the development of robust medical review practices.

What You Will Do:

As a subject matter expert, the Medical Data Reviewer is responsible for ensuring high quality medical review of phase I-III clinical trial data in the field of oncology, neurology and immunology or other therapeutic areas of interest, in compliance with GCP/ICH and regulatory requirements.

Key responsibilities include:

• The Medical Data Reviewer works in close collaboration with the Medical Lead and/or Clinical Research Scientist to set up and coordinate the medical data review process, assists with medical data review and manages medical queries. Specifically, the Medical Data Reviewer ensures that the data is comprehensive from a medical point of view across different studies and projects and supporting database milestones (such as interim analysis, DMCs or Health Authority interactions), database and post lock activities and facilitate resolution of clinical data issues.

• Conducts medical review of the data as per Medical Data Review Plan on incremental listings and patient profiles in close collaboration with Medical Lead and/or Clinical Research Scientist, using pre-established criteria to assure that patient data is complete and medically plausible and to clarify inconsistencies and missing events. Data listings and patient profiles (as well as data visualization tools) will be used to review for plausibility and consistency. Reviewing data for protocol deviations. Raising queries to the sites, and following them until resolution and documenting the medical review according to Medical Data Review Plan.

Your Profile:

• More than 2 years’ experience in pharmaceutical industry or clinical research organization or health care experience, as a Medical Data Reviewer, Medical Monitor or similar roles. Basic knowledge in planning, executing, and reporting global clinical studies.
• Fundamental knowledge of GCP/ICH guidelines, clinical trial design, medical data review, statistics, regulatory processes, and drug development processes in oncology, neurology and/or immunology.
• Demonstrates knowledge and application of statistical analysis methodology and can identify trends, as well as analyzing, interpreting, and reporting data effectively.
• Proven analytical and organizational skills with a strong attention to detail, and the ability to interpret large volumes of complex data.
• Good communication skills - verbal, written and listening
• Educational and/or work experience in the respective therapeutic area (e.g. Oncology, Neurology and/or Immunology) preferred
• Experience in analysis and interpretation of clinical data and a working knowledge of biostatistics, ICH-GCP, and regulatory requirements for clinical studies.
• Proficient English in written/verbal communication and presentation skills.
• Participates in internal and external relevant meetings, as needed.
• Experience in clinical databases, industry techniques and standards. Provides input into the electronic Case Report Form (eCRF) and CRF Completion Guidelines, edit checks, Medical Data Review Plan and related relevant documents as needed.
• Knowledge of patient profiles and data listings. Aptitude to interpret medical history and clinical information, including cancer diagnosis, treatment options and clinical safety and efficacy data (RECIST 1.1 assessment, CTCAE grading other relevant criteria).
• Collaborate with relevant functions to improve the quality of clinical data review/insights with an emphasis on subject safety and eligibility, efficacy endpoints, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Assist in the development and monitoring of the data review strategy, ensuring that critical clinical data review findings are adequately implemented and resolved, leading to a front-loaded data cleaning and high quality study data.
• If applicable, the Medical Data Reviewer may support writing patient narratives or uploading essential documents related to their task to the electronic Trial Master File

Qualifications:

• Degree in a medical profession or life sciences (physician, nurse, pharmacist, scientist) is required. PhD, MBBS, BDS, MD strongly preferable .

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request .

Are you a current ICON Employee?