Postdoctoral Research Fellow, Vertex-Global Regulatory Affairs

Particulars

Posted: 17-Sep-23

Location: Boston, Massachusetts

Kind: Full-time

Wage: Open

Classes:

Tutorial/College
Enterprise/Finance

Inside Quantity: 4605265

Postdoctoral Analysis Fellow, Vertex-World Regulatory Affairs
In regards to the Alternative
Northeastern College’s Pharmaceutical Trade Fellowship Program is a two-year fellowship designed to advance the training and coaching of Pharm.D. graduates in varied areas of business pharmacy together with regulatory affairs, medical data/affairs, affected person security, outcomes analysis, and lots of different areas. This system is a collaboration between Northeastern College and biopharmaceutical business companions.
Our program offers a dynamic educational atmosphere providing fellows the chance for a large breadth of experiences:

• Develop educating expertise via participation in our Educating and Studying Seminar sequence
• Facilitate small and enormous group didactic training in partnership with a school mentor
• Create, current, and publish scholarly analysis via collaborative business and college relationships
• Have interaction with college who take part in varied interdisciplinary
• Community with space residents and different Northeastern fellows through skilled improvement applications, educating seminars, and participation on fellowship committees

In partnership with Northeastern College, Vertex Prescribed drugs Included (Vertex) is providing a two-year World Regulatory Affairs (GRA) PharmD fellowship primarily based on the company headquarters in Boston, Massachusetts.
About Vertex:
Vertex is a world biotechnology firm that invests in scientific innovation to create transformative medicines for individuals with critical ailments. The corporate has a number of authorized medicines that deal with the underlying reason for cystic fibrosis (CF) – a uncommon, life-threatening genetic illness – and has a number of ongoing scientific and analysis applications in CF. Past CF, Vertex has a strong scientific pipeline of investigational small molecule, mRNA, cell and genetic therapies (together with gene modifying) in different critical ailments the place it has deep perception into causal human biology, together with sickle cell illness, beta thalassemia, APOL1-mediated kidney illness, acute and neuropathic ache, kind 1 diabetes and alpha-1 antitrypsin deficiency.
Based in 1989 in Cambridge, Mass., Vertex’s international headquarters is now positioned in Boston’s Innovation District and its worldwide headquarters is in London. Moreover, the corporate has analysis and improvement websites and business workplaces in North America, Europe, Australia and Latin America. Vertex is constantly acknowledged as one of many business’s high locations to work, together with 13 consecutive years on Science journal’s High Employers listing and one in every of Fortune’s 100 Finest Firms to Work For. For firm updates and to study extra about Vertex’s historical past of innovation, go to www.vrtx.com or observe us on Fb, Twitter, LinkedIn, YouTube and Instagram.
Obligations:
The PharmD fellow(s) could have a chance to achieve specialised and in-depth coaching in two distinct areas of GRA, Regulatory Technique and World Labeling for a interval of 8 months. The remaining 8 months of this system shall be spent in a regulatory elective. Regulatory elective alternatives are provided in areas together with CMC, CoRA, Worldwide, Coverage, and Strategic Operations. Particular alternatives might fluctuate relying on the pursuits of the PharmD fellow(s) in addition to the wants of the division. Total, the structured program will present a cumulative set of expertise that can assist facilitate a easy transition to a profitable profession after the fellowship.
Core Obligations:
World Labeling

• Present strategic steering on labeling rules, competitor labeling, and labeling traits
• Lead workforce in negotiating and sustaining aggressive labeling with well being authorities globally

Regulatory Technique

• Handle, develop, and implement regulatory technique in assist of Vertex merchandise and improvement applications
• Present strategic enter and tactical assist to expedite the event, submission, and regulatory approval of latest drug or biologic merchandise

{Qualifications}:
Physician of Pharmacy diploma from an ACPE accredited establishment, eligible for licensure as a pharmacist within the State of Massachusetts.
Wonderful oral and written communication, time administration, and management expertise, potential to work independently and take initiative on quite a lot of tasks on the business website and Northeastern.
Extra Data:
Candidates ought to submit the next APPLICATION MATERIALS by the precedence deadline of October 31, 2023

• Curriculum vitae (CV), uploaded
• Unofficial PharmD transcripts, uploaded
• Cowl letter, uploaded

Three formal letters of advice (LORs) despatched straight from the letter author to [email protected] by November twenty ninth , 2023. LOR writers ought to embrace the candidate’s identify and fellowship program(s) within the topic line (e.g. Smith, John – Alnylam, GSK).
Handle cowl letter and three LORs to:
J. Andrew Orr-Skirvin, PharmD, BCOP
Scientific Professor, College of Pharmacy
Chair, Division of Pharmacy & Well being System Sciences
Director of Pharmaceutical Trade Fellowship Program
360 Huntington Ave, 140TF R218
Boston, MA 02115
Place Kind
Analysis
Extra Data
Northeastern College considers elements comparable to candidate work expertise, training and expertise when extending a proposal.
Northeastern has a complete advantages bundle for profit eligible workers. This contains medical, imaginative and prescient, dental, paid break day, tuition help, wellness & life, retirement- in addition to commuting & transportation. Go to https://hr.northeastern.edu/advantages/ for extra data.
Northeastern College is an equal alternative employer, searching for to recruit and assist a broadly numerous neighborhood of school and employees. Northeastern values and celebrates range in all its varieties and strives to foster an inclusive tradition constructed on respect that affirms inter-group relations and builds cohesion.
All certified candidates are inspired to use and can obtain consideration for employment with out regard to race, faith, coloration, nationwide origin, age, intercourse, sexual orientation, incapacity standing, or some other attribute protected by relevant regulation.
To study extra about Northeastern College’s dedication and assist of range and inclusion, please see www.northeastern.edu/range .
To use, go to https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Most important-Campus/Postdoctoral-Analysis-Fellow–Vertex-World-Regulatory-Affairs_R118616
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About Northeastern College
Based in 1898, Northeastern College is a personal analysis college positioned within the coronary heart of Boston. Northeastern is a pacesetter in worldwide experiential studying, city engagement, and interdisciplinary analysis that meets international and societal wants. Our broad mixture of experience-based education schemes?our signature cooperative training program, in addition to pupil analysis, service studying, and international studying?construct the connections that allow college students to remodel their lives. The College provides a complete vary of undergraduate and graduate applications resulting in levels via the doctorate in 9 schools and colleges.
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