This two-year Fellowship Program in collaboration at Northeastern University and Verastem Oncology is designed to offer Doctor of Pharmacy graduates an in-depth experience in a biopharmaceutical industry setting.
The core mission of the Verastem Regulatory Affairs group is to ensure regulatory compliance and collaborative communications with the Food and Drug Administration, as well as other global regulatory agencies and adherence to associated regulations. This is done by ensuring Verastem product filings are accurate and up-to-date throughout the product life cycle of development and commercialization through the following core activities:
· Relevant clinical, nonclinical, CMC (chemistry, manufacturing and controls), and safety information are submitted to regulatory authorities on a regular basis.
· Seeking advice from the appropriate regulatory authorities throughout product development.
Strategies are implemented to minimize risks and to ensure that regulatory filings contain accurate and up-to-date information on the regulated cross-functional areas (clinical, nonclinical, CMC and safety of Verastem products, while collaborating with regulatory agencies to ensure guidance, both directly and indirectly is adhered to Communication with regulatory agencies, and other concerned bodies is essential to this effort. This includes developing and updating documents within the investigational new drug application, new drug applications and clinical trial applications, as well as specific cross-functional documents such as the investigator brochure and product label. This information must be kept current throughout the life cycle of each product: from development through commercialization.
Regulatory Affairs coordinates Verastem’s intense multi-disciplinary commitment to transparency of our drugs to global regulatory agencies. This fellowship program in regulatory affairs offers Doctor of Pharmacy Graduates the opportunity to participate in multiple aspects of the regulatory affairs function. Fellows will gain practical hands-on experience. They will have the opportunity to take additional courses at Northeastern to expand their knowledge of pharmaceutical industry and drug regulations while earning credit towards an additional graduate degree through the College of Professional Services.
Northeastern University School of Pharmacy focus: Fellows have the opportunity to teach courses in both large and small group settings and co-precept introductory and advanced practice experiential education students. Fellows will also participate in teaching seminars with residents and fellows throughout Massachusetts and will work with Northeastern faculty in the areas of teaching and scholarly projects leading to publication and scientific presentation. The fellows will work primarily at the Verastem Oncology office in Needham, as well as Northeastern offices on campus.
Doctor of Pharmacy degree from an ACPE accredited institution; eligible for licensure as a pharmacist in the State of Massachusetts; excellent communication, time management, and leadership skills; ability to work independently and take initiative on a variety of projects at Verastem Oncology and Northeastern.
Applicants MUST submit ALL of the following APPLICATION MATERIALS by December 10, 2018 to fellowships@Verastem.com:
The Northeastern online application form MUST include the following items: 1. CV and Cover Letter, uploaded 2. Transcripts (*may be unofficial or official), uploaded 3. Names and contact information (only) of the three persons (references) who will be submitting letters of recommendation
Additional Salary Information: Up to $1500 in relocation expenses will be reimbursed
About Northeastern, The Biotech Fellowship
The NORTHEASTERN FELLOWSHIP PROGRAM provides fellows with dynamic biopharmaceutical industry experiences with the benefits of an academic environment. Over two-years, fellows work at one of the partner companies located in the greater Boston and Cambridge, MA areas and at Northeastern University’s School of Pharmacy. WHAT YOU WILL EXPERIENCE: Comprehensive understanding of drug development and commercialization. Robust program personalization to advance the fellow’s career goals. Large and small group teaching; scholarly research with opportunities to publish. Opportunity to pursue graduate degrees in business, public health, regulatory affairs, and others. Network with leaders, entrepreneurs, and drug developers in the biotech capital of the world. PARTNER COMPANIES & POSITIONS: Alkermes, Alnylam, Bioverativ, Tesaro, and Tetraphase. LEARN MORE at NUfellowship.com. SIGN UP for updates: bit.ly/NU_CIF