Title Summer Intern, Quality Management
Who We Are
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Major pipeline expansion and progression is in process.
About the Role
We are looking for an ambitious and detail-oriented intern to work with Click’s Quality Management Systems (QMS) team to support medical device software development of digital therapeutics. During your time at Click you will be introduced to a burgeoning sector of the health tech industry and have the opportunity to learn medical device quality system principles, how they apply to Agile software development, and work within cross-functional teams to implement and facilitate quality system processes. This is a tremendous learning opportunity in a rapidly growing pre-IPO technology company for someone interested in gaining experience within health technology and digital therapeutics.
Priority will be given to candidates who can commit 30 to 40 hours per week to the internship. Internships can be conducted remotely.
— Support Click’s Quality Management System to gain an understanding of medical device development processes and the software development life cycle in a regulated environment.
— Become familiar with medical device software and quality system industry standards and regulations including but not limited to FDA CFR Title 21 Part 820 and ISO 13485:2016.
— Research medical device quality system regulations for software development and use technical writing skills to assist in drafting quality management system procedures and records in responsible area (e.g., procedures, complaint files, CAPA, audit reports).
— Participate in the planning and execution of manual verification and validation testing, help compile current design history file documentation including design records, and collaborate with engineers and product management to resolve process or product related issues.
— Support the implementation and maintenance of the Enzyme QMS platform design controls and other integrations for existing and upcoming projects.
— General quality system support which may include ensuring documents are current and indexed, tracking software problem resolutions through development, and filing user feedback data.
— Current student of 4-year program or graduate program with strong academic record
— Excellent verbal and written communication skills
— Genuine interest in medical device development and/or quality management
— Detail oriented, with consistent organizational skills
— Preferred: experience writing SOPs or other technical writing (in a science or engineering field)
— Preferred: experience writing and/or executing software validation test plans
— Enthusiastic about digital health and healthcare innovation
Equal Employment Opportunity
Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague’s long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague’s temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the “at-will” employment relationship between the colleague and Click Therapeutics.