The Regulatory Affairs (RA) department at the Novartis Institutes for BioMedical Research (NIBR) is responsible for providing strategic regulatory guidance to advance a diverse portfolio of compounds through the early phases of clinical research from first-in-human (FIH) Phase I trials through proof-of-concept (PoC) Phase IIa studies. The fellow will spend the first year of the program in RA Early Development, which supports a wide range of General Medicine disease areas, including Autoimmunity/Transplantation/Inflammation, Cardiovascular & Metabolism, Cell & Gene Therapies, Infectious Diseases, Musculoskeletal, Neuroscience, Ophthalmology, Respiratory, as well as medical devices. The fellow will spend the second year of the program working with the RA teams that support Translational Clinical Oncology (TCO) and Oncology Precision Medicine (OPM).
The fellow will learn to:
Support major regulatory submissions to enable conduct of FIH and PoC clinical studies, including Investigational New Drug applications (INDs) and Clinical Trial Applications (CTAs).
Outline early and full development regulatory strategy for projects (small molecules, biologics, cell and gene therapies) based on alignment and input from cross-functional drug development teams as well as interpretation of relevant health authority guidance documents and regulatory precedent.
Support and lead preparatory activities for meetings with global health authorities, including pre-IND and scientific advice meetings.
Work with teams to prepare regulatory maintenance submissions, including IND Annual Reports, Development Safety Update Reports (DSURs), and protocol amendments.
Utilize the procedures, systems, and databases that comply with requirements for electronic record-keeping.
Conduct regulatory intelligence research to inform the development strategy for a particular drug, disease, or therapeutic area.
To be considered for an interview at Midyear, please register for both ASHP Midyear and PPS and then complete a fellowship application on the MCPHS Fluid Review application portal. Visit https://mcphs.fluidreview.com/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via PPS to schedule interviews.
Before ASHP Midyear Clinical Meeting
Applicants must upload the following application materials to the online portal prior to November 26, 2018:
Letter of intent
Unofficial college transcript
Contact information of three references for letters of recommendation.
Incomplete applications WILL NOT be reviewed. ASHP Clinical Midyear Meeting interviews CANNOT be scheduled until these materials have been submitted. Please keep in mind that this is a competitive process and applicants are encouraged to complete their applications as soon as possible.
After ASHP Midyear Clinical Meeting
The three letters of recommendation must be submitted by the three provided contacts no later than December 10th.
Top candidates will be invited for onsite interviews at the sponsoring company’s location. Final candidates will be required to go through additional screening / onboarding as required by MCPHS University.
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: Fellows will receive a competitive stipend and benefit 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.