The CQA fellow will work with associates in Clinical Quality and Operations supporting activities in the ongoing and upcoming clinical studies. This role provides the opportunity to be involved in the early phases of drug development. The fellow will learn the phases of drug development and the associated current good clinical practice requirements (cGCP) and International Conference on Harmonization (ICH) guidelines. The fellow will also have the opportunity to review and understand the content of various documents that are developed in conjunction with a clinical study. This Fellowship will also provide the opportunity to learn about the regulatory process requirements and approvals needed in support of clinical research.
Our fellow will participate in and learn to:
Prepare and present compliance data to clinical management teams and report on status of tasks
Review and comment on essential documents associated with clinical trials ensuring compliance with standard operating procedures, and regulatory requirements
Participate and support quality actions in preparation for submission and inspection readiness
Participate in clinical site monitoring visit and/or audit
Assist with ICH/GCP Training
Assist in tracking of quality operational metrics and KPIs
Support deviation/audit root cause analysis and assist in the creation of clinical quality incident/investigation materials, including documents, presentations, and reports.
Participate in extended learning about Novartis Quality from Discovery to Marketed Product.
Other projects that our fellow will be leading or supporting:
Risk Based Approach to developing meaningful CQA Metrics
Participate and support execution of quality assessments in preparation of IND submission of new products.
Support and execute Quality projects
Duration: Two Years
Start Date: Early July 2020
Please view the MCPHS University Novartis Biopharmaceutical Industry Fellowships website for more information.
To be scheduled for an interview at the ASHP Clinical Midyear Meeting, applicants must upload the following application materials to the online portal by December 2, 2019:
Letter of intent
Unofficial college transcript
Contact information of three references for their recommendations
In addition, registration is required with the American Society of Health-Systems Pharmacist (ASHP) Midyear Clinical Meeting Personnel Placement Service (PPS) to interview at Midyear.
**For the CQA program we will conduct phone screenings before Midyear, it is recommended to have your materials submitted to the MCPHS portal as soon as possible but no later than November 27th.
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis, with interviews at the American Society of Health Systems Pharmacists (ASHP) Midyear meeting.
Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy at the commencement of the program.
Candidates must have strong written and verbal communication skills and a strong interest in pursuing a career within the biopharmaceutical industry.
All candidates must have authorization to work in the United States throughout the duration of the one or two-year fellowship. No visa sponsorship will be provided.
Additional Salary Information: Additional Salary Information: Fellows will receive a competitive salary and benefits package, including comprehensive health insurance.
About MCPHS University/Novartis Institutes for BioMedical Research
The Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis. We are committed to discovering innovative medicines to treat diseases with high unmet medical need. With more than 6,000 scientists and physicians around the world, our open and entrepreneurial culture encourages collaboration as we work to push the boundaries of science to change the practice of medicine.