Division/College: Bouve College of Health Sciences
FT/PT: Full Time
This two-year Fellowship Program in collaboration at Northeastern University and Alnylam Pharmaceuticals is designed to offer Doctor of Pharmacy graduates an in-depth experience in a biopharmaceutical industry setting. Alnylam focus: Regulatory Affairs at Alnylam is a group with diverse scientific, technical, and clinical expertise with team members in offices in the US, EU, and Japan. The team is responsible for creating and implementing global innovative strategies to support expedited drug development and approval of Alnylam's products. Effective support and management continues throughout Alnylam's product life-cycle. The Regulatory Affairs Fellow will focus in Global Labeling Strategy and participate in the development of regional labels and core reference documents.
Collaborate with Clinical, Commercial and Medical teams in US and EU to achieve regulatory milestones and support new product launches
Actively participate in creation and implementation of product prescribing information
Support the establishment and process development for a global labeling function
Working cross-functionally to support development of a core reference label that will ensure consistency across the globe regarding the safe and effective use of Alnylam's products
Development and refinement of labeling strategies
Critical analysis and presentation of labeling and drug development precedent
Supporting the development and maintenance of regional labeling for approved products
Coordination and management activities with internal team and external consultants
Research of local/regional regulatory requirements for labeling
Supporting, preparing and submitting international marketing authorization applications (e.g., MAAs, NDAs)
WHAT WE VALUE
Highly motivated individuals with a results-oriented mindset
Application of critical thinking and reasoning
Ability to independently work and adapt in a fast-paced environment Core Regulatory affairs Rotations:
Advertising and Promotion
International Regulatory Affairs Strategy
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 at Alnylam's office in Cambridge, Northeastern offices on campus, as well as various clinical practice settings (hospitals, clinics, pharmacies) with Northeastern faculty.
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 Alnylam and Northeastern.
Applicants MUST submit the following APPLICATIONMATERIALS by December 1, 2018: The Northeastern online application form MUST include the following items: 1. Curriculum vitae, uploaded 2. Transcripts (*may be unofficial or official), uploaded Three formal letters of recommendation (LoRs) sent directly from the letter writer, and a letter of intent will be requested from candidates who advance to an onsite interview. Letter of intent and LoRs are not required until formally requested and specific instructions will be provided upon request of these documents. Upon request, the letter of intent should be sent by the candidate to PharmDfellowships@northeastern.edu. LOR writers should include the candidate's name and fellowship program(s) in the subject line. (e.g., Smith, John – Alnylam, Tesaro & Bioverativ). The Bouvé College of Health Sciences at Northeastern University is one of nine colleges/schools at Northeastern University and is a national model for education and research in the health, psychosocial and biomedical sciences. Comprised of three schools – Nursing, Pharmacy and Health Professions — over 2200 undergraduates and 1700 graduate students are enrolled in more than 30 degree-granting programs. Complementing our instructional programs, we house nine centers and institutes and the College successfully competes for NIH, NSF and foundation funding. Northeastern University is on an exciting trajectory of growth and innovation. The University is a leader in inter-disciplinary research, urban engagement, experiential learning, and the integration of classroom learning with real-world experience. Northeastern University is home to 20,000 students and to the nation's premier cooperative education program. The past decade has witnessed a dramatic increase in Northeastern's international reputation for research and innovative educational programs. A heightened focus on interdisciplinary research and scholarship is driving a faculty hiring initiative at Northeastern, advancing its position amongst the nation's top research universities. Northeastern University is situated on the Avenue of the Arts in Boston's historic Back Bay, four blocks from the Longwood Medical Area, encompassing Harvard Medical School, Boston Children's Hospital, Brigham & Women's Hospital, and Beth Israel Deaconess Medical Center, and eight blocks from the Boston Medical Center.
Requisition Number: STFR004945
Internal Number: 57386
About Northeastern University
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.