Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description

ESSENTIAL JOB FUNCTIONS*

Tactical

• Assisting in the managing and preparing documents into electronic QMS (eQMS).
• Assisting with activities pertaining to product and process change management.
• Assisting the Product, Engineering and Operations teams with quality assurance activities and creation of records according the internal QMS & ISMS procedures and included in the entire life cycle of the product.
• Participates in computer system validation activities by providing QA review of documentation and records.
• Participates in the computer system and digital health platform change control and periodic review processes.
• Assisting in managing and tracking training documentation and compliance.
• Enables training compliance through the planning, preparation and conduct of training and/or the publication of blog posts.
• Participating and supporting in the preparation of internal/external documents and reports required by Alira Health procedures.
• Participates in or leads meetings as required.

Strategic

• Maintains clear, regular, and professional communication with staff.

• Responds to requests and emails promptly and efficiently.

• Adheres to and ensures compliance with ICH GCP guidelines, FDA regulations, ISO standards and company SOPs.

• Escalates issues in a timely fashion.

• Performs additional duties as assigned.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• BS from an undergraduate program or equivalent experience in engineering, software development, or a related field.
• General understanding of the pharmaceutical and biomedical industry and the clinical development process.
• Basic understanding of regulations and guidelines relevant to the conduct of clinical investigations, such as ICH GCP.
• Basic knowledge of standards and regulations relevant to medical devices such as ISO 9001, ISO 13485, ISO 14971, ISO 27001, IEC 62304, IEC 62366, MDD, MDR and 21 CFR 820.
• Basic knowledge of the computer systems validation process and regulatory requirements relevant to the use of electronic records and signatures, such as 21 CFR Part 11.
• Awareness of data protection laws and regulations, such as GDPR, CCPA, HIPAA and EU Directives.
• Ability to be careful, thorough, and detail oriented.
• Ability to multi-task and work effectively in a fast-paced environment.
• Fluent in English, both written and verbal; fluency in Italian and/or French a plus.
• Good communication and interpersonal skills.
• Proficient with MS Office Suite, particularly Word, Excel, PowerPoint, and SharePoint/Teams.

WORKING CONDITIONS/PHYSICAL DEMANDS

• Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.

Contract Type

Intern (Fixed Term) (Trainee)