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Postdoctoral Research Fellow, Alnylam--Regulatory Affairs
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Position Number: 5638568
Location: Boston, MA
Position Type: Business - Business Law

Postdoctoral Research Fellow, Alnylam--Regulatory Affairs

About the Opportunity

About the Opportunity:

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. Critical to the success of the program is our ability to prepare Fellows to meet the ongoing workforce needs in various areas of industry.

Our program gives fellows an opportunity to work with our innovative biopharmaceutical industry partners while collaborating with Northeastern University faculty in professional and career development, service, scholarship, and teaching.

In partnership with Northeastern University, Alnylam is offering a two-year Regulatory Affairs PharmD fellowship based in Cambridge, Massachusetts.

About Alnylam:

Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.

Responsibilities:

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 experience gained throughout this fellowship will allow the Regulatory Affairs fellow to develop a deep understanding of Global Regulatory Strategy across development programs within rare and prevalent diseases and gain hands-on project-based exposure across other regulatory affairs disciplines as described below:

Support, prepare, and submit a wide range of regulatory filings such as investigational new drug applications, clinical trial applications, new drug applications and international marketing authorization applications

Collaborate with Clinical, Global Patient Safety and Risk Management, Biostatistics, and Medical teams in US and EU to achieve regulatory milestones

Participate in cross-functional meetings to support and contribute to the clinical development plan and regulatory strategy

Conduct guidance and precedent research to support regulatory strategy

Support the development and lifecycle maintenance submissions for commercial programs

Potential project-based exposure to other regulatory disciplines (regulatory labeling, regional advertising and promotion, and/or chemistry, manufacturing, and controls)

Northeastern University School of Pharmacy

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 local residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees

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 US.

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.

Additional Information:

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st, 2024.

Curriculum vitae (CV), uploaded

Unofficial PharmD transcripts, uploaded

Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 22nd, 2024. 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

Position Type

Research

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.

Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.

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://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Postdoctoral-Research-Fellow--Alnylam--Regulatory-Affairs_R127550