Location:
Tucson, Arizona or the surrounding vicinity (e.g., Oro Valley, Marana, Catalina, Vail, South Tucson). Note: Phoenix is not in the Tucson vicinity.
Salary Range:
Pay rate: Up to $62/hr.
Introduction
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
Required Skills & Qualifications
- True project management experience in the Biotech/Pharma space.
- Located in Tucson, Arizona or the surrounding vicinity.
- 4 years of experience in project management/engineering/business in the diagnostic, medical device, pharmaceutical, or biotech industry.
- At least one year of experience in clinical biomarker or In Vitro Diagnostic development, CDx development, analytical and clinical validations, regulatory submissions, instrument/systems development, or program management.
- Experience in a regulated industry (e.g., FDA 21 CFR part 820, ISO 13485, ISO 9001).
- Proficiency in using Planisware, MS Office, and Google Suite, and knowledge of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc.
- Working knowledge of Agile best practices and Agile-at-Scale methodologies (e.g., SAFe), and experience operating in hybrid Waterfall-Agile environments.
- Prior work experience at client or in client's industry.
Applicants must be able to work directly for Artech on W2.
Preferred Skills & Qualifications
- Master's degree, preferably in a Life Sciences field, and 6 years of project management/engineering/business experience in the diagnostic, medical device, pharmaceutical, or biotech industry. Alternatively, a Ph.D. with 3 years of project management experience in those areas.
- 3 years of clinical biomarker or In Vitro Diagnostic development experience in CDx development, analytical and clinical validations, regulatory submissions, or instrument development and program management.
- Significant experience managing complex project team structures, including third-party external co-development partners.
- Project Management Professional (PMP) and/or SAFe Agile certifications.
Day-to-Day Responsibilities
- Proactively drive the development activities for Companion Diagnostics (CDx) Development projects in collaboration with third-party Pharmaceutical partners.
- Own timeline creation and management using industry-standard tools such as Planisware.
- Collaborate with project team members and stakeholders to identify resource needs and optimize team allocation.
- Drive the project budget from initial scoping through post-contract execution.
- Define project objectives and establish scope baselines, proactively identifying and addressing any deviations.
- Own project team meetings and engage stakeholders through appropriate channels.
- Proactively identify, evaluate, and prioritize project risks, engaging stakeholders to co-develop mitigation strategies.
- Ensure project execution is in compliance with Quality Management System (QMS) framework and regulatory guidelines.
- Facilitate effective collaboration and decision-making with external Pharma entities.
- Select and apply appropriate project methodologies, including hybrid Agile practices and Scaled Agile Framework (SAFe) where applicable.
Company Benefits & Culture
- Innovative work environment focused on advancing science and healthcare access.
- Opportunities for continuous learning and professional development.
- Collaborative culture aimed at creating a healthier future.
For immediate consideration please click APPLY to begin the screening process with Alex. Share your resume at aditya.singh3@artech.com