Senior Advisor, Regulatory Strategy, MIT Center for Biomedical Innovation
What: Part-time, Contractor
Position Overview: Work with the Executive Director and play a key role in a unique multi-stakeholder incubator environment focused on enhancing the value and sustainability of pharmaceutical innovation for all stakeholders across the global healthcare industry. The New Drug Development Paradigms initiative (NEWDIGS) operates as a cutting edge innovation platform involving senior leaders from biopharmaceutical companies, regulatory agencies, payer organizations, and MIT, along with other key stakeholders from the global healthcare industry. NEWDIGS’ initial phase of work focused on Adaptive Licensing (AL) and helped to inform the launch of the European Medicines Agency’s (EMA) pilot program on AL/Medicines Adaptive Pathways to Patients (MAPPs) in Spring 2014.
The next phase for NEWDIGS will focus on supporting the implementation of AL/MAPPs through a variety of activities involving a number of European and other global collaborators, as well as MIT faculty and students. The Senior Advisor will play an important technical and strategic role across these activities, serving as our primary internal expert on emerging regulatory issues.
This position provides a unique high leverage career opportunity to shape change and drive meaningful impact for patients and for global health in the near and long term future.
Responsibilities & Requirements: See this PDF job posting.
How: Please send cover note and CV to:
Gigi Hirsch, MD
MIT Center for Biomedical Innovation
CBI UROP Student
What: This is a project focused on using big data to develop a risk management framework for detecting non-traditional adulteration of food and drug products emanating from the global supply chain. Further details here.
Responsibilities: The project will involve searching for and collecting data from a wide array of online sources and electronic databases, performing content analysis, converting unstructured text data into a structured database, and performing basic analysis on the data.
Prerequisites: Reader of Chinese language with an interest in big data. Intermediate programming skills for web crawling and databases are desired.
When: ASAP for Fall & Spring
How: Send cover letter and resume to Professor Karen Zheng.
edX Course Development
CBI has an available position to aid us in the creation of a new online Principles of Biomanufacturing course to be offered on edX. This position is well suited for an undergraduate with interest in the biotech industry, biopharmaceutical manufacturing, and/or edX. The position will aid in all aspects of course development from collecting and evaluating existing biopharmaceutical manufacturing educational resources, helping to draft and evaluate potential homework questions to be used for the online course, to aiding in scripting lecture material and initial testing of the online course. The course is expected to go live on edX by October of 2014.
Key qualifications: This role will require superior attention to detail, the ability to summarize data using secondary resources, and a familiarity with the edX platform. Familiarity with the biopharmaceutical industry and experience with coding languages (such as Java Script, html, Malab, Python, etc.) is a plus, but not required.
Hours: 10-20 (flexible) Rate: $10 per hour
Contact: Please email your CV or resume, a cover letter describing relevant experience and interest and three references to firstname.lastname@example.org. No phone calls, please.