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Postdoctoral Research Fellow - Alnylam Regulatory Affairs

Employer
Northeastern University
Location
Massachusetts, United States
Salary
Salary Not specified
Date posted
Sep 16, 2020

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Position Type
Faculty Positions, Business & Management, Other Business & Management
Employment Level
Post-Doc
Employment Type
Full Time


Postdoctoral Research Fellow - Alnylam Regulatory Affairs

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 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

Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. Alnylam currently has two commercial RNAi therapeutic products. The first product is approved in the U.S., EU, Canada, Japan, and Switzerland for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults and the second product is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). Alnylam also has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,300 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2019 and Science Magazine's #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

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, excellent communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at Alnylam and Northeastern.


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

Additional Information:
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 15, 2020:
  1. Curriculum vitae (CV), uploaded
  2. Unofficial PharmD transcripts, uploaded
  3. Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by December 4, 2020. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam, GSK).

Address cover letter and three LORs to:
J. Andrew Orr-Skirvin, PharmD, BCOP
Clinical Professor, School of Pharmacy
Chair, Department of Pharmacy & Health System Sciences
Director of Pharmaceutical Industry Fellowship Program
360 Huntington Ave, 140TF 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.

To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.


To apply, visit https://careers.pageuppeople.com/879/cw/en-us/job/503884

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