Overview

This position will support the Xeris Quality Assurance and Regulatory Departments with ensuring our commercial and pipeline products are managed in accordance with Xeris procedures and any local/Federal/external regulatory requirements. This internship role will introduce the candidate to various aspects of the Xeris Quality Management System (QMS). The intern will work with a Cross functional team to create a Regulatory Intelligence Hub to assist with the data sourcing and aggregation of current country specific regulations to aid compliance and strategic decision making.

Responsibilities

• Support activities related to the Xeris QMS. These activities include:
  • Document Control/Training/Record Retention
  • Deviations/Corrective and Preventive Actions (CAPAs)s/Product Complaints
  • Supplier Management and Internal Audits
  • Batch Documentation Review/Release
  • Quality Management Review
  • Software Validation
• Support Regulatory and Cross Functional team in development of Regulatory Intelligence Hub to assist with data sourcing and aggregation.
• Review and report on relevant FDA guidance and/or rulemaking related to Xeris’s business.
• Keep abreast of competitive product advertising and promotion activities of Xeris competitors across its product portfolio.
• Become knowledgeable with FDA drug approval and pre-approval activities related to Xeris’s product development program(s).
• Assist with regulatory intelligence assignments to research country-specific requirements.
• Other duties as assigned.

Qualifications

• Pursuing a bachelor’s or master’s degree in Life Sciences/Biotech/Pharmaceuticals
• Proficiency in Microsoft Office – Must have intermediate level Excel skills
• Ability to prioritize tasks and drive a project to completion within deadlines
• Competencies: Teamwork & Collaboration, Written and Verbal Communication Skills, Adaptability, Attention to Detail, Organizational Skills
• Position may require periodic evening / weekend work, and periodic overnight travel, as necessary to fulfill obligations.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.