MCPHS University / Novartis – Regulatory Affairs, Post PharmD Fellow
MCPHS/Novartis Institutes for BioMedical Research
Location: Cambridge, Massachusetts
Fellows will receive a competitive stipend and benefit package, including comprehensive health insurance
Employer will assist with relocation costs.
Novartis Institutes for BioMedical Research (NIBR), in collaboration with MCPHS, offers a unique fellowship program to promote the role of the Doctor of Pharmacy (PharmD) within the biopharmaceutical industry. A fellow gains extensive experiences through various practical activities in both industry and academic settings, which could enhance the potential for accelerated career development.
The Regulatory Affairs (RA) department at NIBR is responsible for providing global 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. RA Early Development supports programs across Oncology, Hematology and a wide range of General Medicine disease areas, including Autoimmunity/Transplantation/Inflammation, Cardiovascular & Metabolism, Musculoskeletal, Neuroscience, Respiratory, and Tropical Diseases. Over the course of the two-year fellowship, the fellow will gain exposure to and assist in developing the global regulatory strategy for programs in a multitude of these disease areas which will lay the foundation to perform as a strong regulatory professional.
Our fellow will learn to:
Support major global regulatory submissions to enable the conduct of FIH and PoC clinical studies, including Investigational New Drug applications (INDs) and Clinical Trial Application (CTAs)
Outline early- and late-stage development regulatory strategy for projects (small molecules, biologics, 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, pre-submission, and scientific advice meetings
Work with teams to prepare global regulatory maintenance submissions including IND Annual Reports, Development Safety Update Reports (DSURs), as well as protocol and information amendments
Conduct regulatory intelligence research to inform the development strategy for a particular drug, disease, or therapeutic area
Utilize the procedures, systems, and databases to comply with requirements for electronic record-keeping
To be considered for an interview, please complete a fellowship application on the MCPHS SMApply application portal. Visit https://mcphs.smapply.io/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via email to schedule interviews.
The MCPHS application portal will open up on October 3, 2022. Applicants must upload the following application materials to the online portal by November 11, 2022:
Letter of intent
Unofficial college transcript
Contact information for three references. References will receive an electronic recommendation form to complete separately.
Incomplete applications WILL NOT be reviewed. 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.
Three recommendation evaluation forms must be submitted no later than December 1, 2022, via the online portal. This is NOT a letter of recommendation but an online form that the reference will need to complete.
Rolling Application Review & Interviews
All submitted applications will be reviewed on a rolling basis. Interviews will also be offered on a rolling basis and opportunities are limited. Priority will be given to those applicants who apply early, well in advance of the deadline.
Rolling interviews will begin mid-October with pre-screens and a mixture of interview rounds, and will conclude in December at the end of the ASHP Midyear Clinical Meeting. Candidates will be notified if selected for an interview.
ASHP Midyear & Onsite Interviews
The fellowship program will be conducting in-person interviews at the ASHP Midyear Clinical Meeting in Las Vegas. Applicants are strongly encouraged to attend. Candidates attending in-person will not be able to interview without registering for both ASHP and PPS. Please refer to the ASHP & PPS website for registration details.
Top candidates may be invited for interviews at the sponsoring company’s location pending COVID – 19 restrictions.
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, MCPHS in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than December 7, 2022.
Final candidates will be required to go through additional screening / onboarding as required by MCPHS.
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis. 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 (i.e., TN, H-1B, STEM OPT, etc.).
About MCPHS/Novartis Institutes for BioMedical Research
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
The Novartis global clinical pipeline includes more than 200 projects and over 500 clinical trials. Within NIBR, we have more than 5,600 dedicated scientists and physicians, working across 6 global campuses.