Postdoctoral Research Fellow Alnylam--Regulatory Affairs
Postdoctoral Research Fellow Alnylam--Regulatory Affairs
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$ 59423 - 83934
1 Vacancy
Job Description
About the Opportunity
About the Opportunity:
Northeastern University Pharmaceutical Industry Fellowships Program is a twoyear 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 twoyear 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 Prizewinning 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 peoplefirst 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 weve 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 Magazines Top Biopharma Employers one of Americas 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 Alnylams products. Effective support and management continue throughout Alnylams 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 handson projectbased 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 crossfunctional 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 projectbased 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 coprecepting students on pharmacy practice experiences including Northeasterns unique coop 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 Alnylams 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:
- Curriculum vitae (CV) uploaded
- Unofficial PharmD transcripts uploaded
- Cover letter uploaded
Three formal letters of recommendation (LORs) sent directly from
the letter writer to LOR
writers should include the candidates name and fellowship
program(s) in the subject line (e.g. Smith John Alnylam GSK).
Please note that we will be reviewing applications on a rolling basis
Address cover letter and three LORs to:
J. Andrew OrrSkirvin 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
ResearchAdditional 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 for more information.
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.
Compensation Grade/Pay Type:
108SExpected Hiring Range:
$59423.00 $83934.50With the pay range(s) shown above the starting salary will depend on several factors which may include your education experience location knowledge and expertise and skills as well as a pay comparison to similarlysituated employees already in the role. Salary ranges are reviewed regularly and are subject to change.
Employment Type
Full-Time
