About Northeastern: Founded in 1898, Northeastern is a global research university and a world leader in experiential learning. The same commitment to connecting with the world drives our use-inspired research enterprise. The university offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools. Our campuses in Charlotte, N.C., San Francisco, Seattle, and Toronto are regional platforms for undergraduate and graduate learning and collaborative research. Northeastern pursues advanced research in security and materials at the Innovation Campus in Burlington, Massachusetts, and in coastal sustainability at the Marine Science Center in Nahant, Massachusetts.
About the Opportunity: The Northeastern University Biopharmaceutical Industry Fellowship Program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:
Develop teaching skills through participation in our Teaching and Learning Seminar series
Facilitate small and large group didactic education in partnership with a faculty mentor
Utilize a layered learning model in experiential education by co-precepting students on pharmacy practice experiences including Northeastern's unique co-op program
Create, present, and publish scholarly research through collaborative industry and university relationships
Engage with faculty who participate in various interdisciplinary graduate programs including biotechnology, nanomedicine, immunology, health informatics, and drug discovery
Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees
About Alnylam: Founded in 2002, Alnylam Pharmaceuticals established an unwavering commitment to harnessing the power of RNA interference (RNAi) for treating rare conditions for patients with high unmet medical needs. Alnylam has led the translation of RNAi to an innovative class of approved and investigational medicines used to treat a wide range of diseases using its powerful, clinically validated approach. In the summer of 2018, Alnylam established a new class of medicines, pioneering the delivery of RNAi therapeutics to patients through the FDA and EMA approval of ONPATTRO(patisiran). This is the first of multiple launches anticipated in the Alnylam 2020 guidance for the advancement and commercialization of RNAi therapeutics. The passionate and dedicated employees at Alnylam look forward to delivering its medicines to patients who need them around the world.
In 2015, Alnylam Pharmaceuticals partnered with Northeastern University to offer a unique fellowship opportunity in the heart of Boston. The program set out to equip postdoctoral PharmDs with the skills necessary to develop the advanced medicines of the future, like RNAi. The goal was and remains the same: to cultivate the future leaders of biotechnology and allow fellows to pioneer new therapies for patients. Alnylam fellows are grounded in their core expertise area but utilize the fellowship's flexibility to branch out and discover other opportunities throughout the organization with personalized rotational experiences. Part of the backbone of the fellowship program is the Northeastern University teaching opportunities which allow fellows to share their knowledge in an educational setting.
Regulatory Affairs at Alnylam is a global group with diverse scientific, technical, and clinical expertise. 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 continue throughout Alnylam's product life-cycle. Assuming increasing responsibility over the two years, the Global Regulatory Strategy fellow will gain hands-on experiences in novel regulatory pathways by participating in unique opportunities within rare disease space.
Responsibilities: Alnylam Regulatory Affairs
Supporting, preparing and submitting international marketing authorization applications (e.g., MAAs, NDAs)
Collaborate with Clinical, Commercial and Medical teams in US and EU to achieve regulatory milestones and support new product launches
Conduct guidance and precedent research to support regulatory strategy and clinical development
Actively participate in creation and implementation of product prescribing information
Supporting the development and maintenance of regional labeling across programs
Coordination and management activities with internal team and external consultants
Research of local/regional regulatory requirements
Critical analysis and presentation of regulatory intelligence and industry surveillance
The fellows will primarily work at Alnylam's office in Cambridge, Massachusetts. Northeastern University responsibilities will be carried out on the Northeastern Boston campus.
Qualifications: Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.
Preferred Qualifications: Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.
Salary Grade: 10
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of December 1, 2019:
Curriculum vitae (CV), uploaded
Unofficial college transcripts, uploaded
Cover letter, uploaded
Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by December 13, 2019. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam).
Address cover letter and three LORs to: J. Andrew Orr-Skirvin, PharmD, BCOP
Associate Clinical Professor, School of Pharmacy
Chair, Department of Pharmacy & Health System Sciences
Director of Biopharmaceutical Industry Fellowship Program
360 Huntington Ave
140 The Fenway, R218
Boston, MA 02115
Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.
All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.
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.