Senior Medical Reviewer (Alexion)

This is what you will do:

The Medical Monitoring Unit is a specialized department within ARDU’s Research and Development organization dedicated to the meticulous medical review and monitoring of efficacy and safety data collected in clinical trials to ensure completeness, robustness, consistency, and accuracy of critical medical data to uphold the highest standards of data integrity and maintain the safety of clinical trial participants. The mission of the Medical Monitoring Unit is ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as to allow for the intended label indication by involvement in activities related to the design, conduct, monitoring, data interpretation and reporting of individual clinical trials.

The Senior Medical Reviewer is a scientifically oriented subject matter expert responsible for reviewing important and pre-specified medical data in clinical trials (with focus on late phases) as operated under the Research and Development (R&D) division of Alexion. The Senior Medical Reviewer will work closely with the study team (including but not limited to the following roles: Global Clinical Lead, Global Study Leader, Principal Study Data Manager, Study Statistician and Statistical Programmer, to ensure well-defined standards are outlined during the study and relevant documents and tools are in place). During the recruitment and maintenance phases of the clinical trial, he/she uses the appropriate review tools to evaluate and query critical medical and safety data and to perform regular quality checks on study level (if applicable).

You will be responsible for:

Leadership and Subject Matter Expertise:

• Serve as a subject matter expert for handling medical/safety data, ensuring data completeness, medical accuracy, and coding consistency.

• Lead and oversee activities related to tools, systems, and processes by sharing best practices and supporting standardization.

• Mentor and train less experienced staff to ensure consistent processes and efficient review of critical medical/safety data across studies within the same molecule/program/indication.

• Identify opportunities to improve deliverables and best practices.

• Lead quality assurance of deliverables and oversee the quality of junior staff by performing regular quality checks at the study level (if delegated).

Technical and Analytical Support:

• Review patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, generating applicable queries as needed.

• Prepare aggregated data visualization and facilitate meetings related to the review of medical data at the study level (if applicable).

• Provide input into the process of setting automated patient narratives and establishing handwritten patient narratives, including guideline development and quality control processes.

Study Support and Collaboration:

• Serve as a member of the Study Team, reporting on Medical Monitoring deliverables.

• Work with study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation across the same program/molecule/indication.

• Escalate urgent and critical findings and observations, including medical cases and adverse events, to the study physician as appropriate.

• Support less-experienced staff with study activities at all stages (setup, maintenance, closure).

• Take on tasks as assigned by the Senior Director/Director/Associate Director, Medical Monitoring.

Project Work and Continuous Improvement:

• Lead and coordinate well-defined non-drug project work, including training activities, continuous improvement, and development of procedures as needed.

You will need to have:

Education and Experience:

• Educational degree (BSc/MSc/PhD) in Life Science or equivalent; work experience in directly related fields (preferably medicine, pharmacy, veterinary, biotechnology, nurse, dentist).

• Minimum two years of experience working on clinical studies and/or study safety methodology in the Biotech/Pharma/CRO industry or equivalent.

Skills and Abilities:

• Demonstrated ability to manage change and uncertainty for self and teams.

• Basic project management skills, including risk management, designing and planning work, prioritizing proactively, and decision-making within the scope of expertise.

• Excellent time management and the ability to solve complex, multifactorial problems.

• Proven ability to simplify complex problems/communication and summarize large amounts of complex information concisely.

• Understanding and managing the business impact of own and team actions.

• Supervising others’ work and providing support in areas of expertise.

• Demonstrated ability and willingness to work and lead cross-functionally with internal and external partners on global studies across different phases of drug development or therapy areas.

• Team player with the ability to work individually.

Technical Knowledge:

• Understanding of the clinical study and drug development process.

• Knowledge of ICH/GCP Guidelines.

• Knowledge of SAE reporting requirements.

• Quality focus and strong analytical skills.

• Excellent knowledge of spoken and written English.

• Computer proficiency, including Microsoft Outlook, Excel, and Microsoft Power Platform.

Values and Behaviors:

• Exhibit Alexion Values and Behaviors.

We would prefer for you to have:

• Experience using electronic data capture systems, query management, and medical review tools, e.g. JReview, JMP Clinical, Elluminate, or Spotfire

• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks

• Knowledge of medical coding dictionaries and conventions (e.g. MedDRA, WHO DD)

• Programming experience in data analysis and/or data mining set-up (e.g. Python, R, SAS)

• Familiarity with Risk-Based Monitoring principles in clinical trials

• Negotiation and influencing skills

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.