Full-Time
Clinical Laboratory Information Specialist
Precision AQ
501-1,000 employees
Data-driven drug access and launches
Compensation Overview
$83.2k - $124.8k/yr
Frederick, MD, USA
In Person
Fully onsite at Frederick, Maryland location; no remote work.
Bachelor's, Master's
 Medical, Clinical & Veterinary (1) |
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- Bachelor’s Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field required
- 5-8 years of related experience in clinical laboratory operations, laboratory informatics, or business analysis
- Strong experience with laboratory systems (LIS, LIMS, middleware, instrument interfaces)
- Demonstrated expertise in UAT coordination and execution
- Hands-on experience with system validation in regulated environments (GxP, CLIA, CAP, FDA)
- Experience authoring validation and regulatory documentation
- Lead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologies
- Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirements
- Partner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use cases
- Facilitate defect tracking, triage, and resolution in collaboration with IT and vendors
- Ensure traceability between requirements, test cases, and outcomes
- Plan and execute system validation activities in accordance with regulatory standards (e.g., GxP, FDA 21 CFR Part 11, CLIA, CAP)
- Author and/or review validation deliverables, including: Validation Plans (VP), Requirements Specifications (URS/FRS), Risk Assessments, IQ/OQ/PQ protocols and reports, Traceability matrices
- Ensure systems are audit-ready and compliant with internal quality systems and external regulatory expectations
- Support audit and inspection activities, including responses and corrective actions
- Develop and maintain SOPs, work instructions, and supporting documentation related to laboratory systems and processes
- Ensure documentation aligns with quality management system (QMS) requirements
- Collaborate with Quality Assurance to maintain compliance and support continuous improvement initiatives
- Maintain document control and versioning in accordance with regulatory standards
- Gather, analyze, and document business and functional requirements from laboratory stakeholders
- Translate complex laboratory workflows into system requirements and technical specifications
- Serve as a liaison between laboratory operations, IT, vendors, and quality teams
- Facilitate workshops, meetings, and process mapping sessions
- Support system implementation, upgrades, and enhancements across laboratory platforms
- Identify opportunities to improve efficiency, data integrity, and compliance through system optimization
- Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations
- Experience with specific LIS platforms (e.g., Epic Beaker, SCC Soft, Sunquest, Cerner Millennium)
- Familiarity with data standards (HL7, interfaces, instrument connectivity)
- Experience in audit/inspection readiness and regulatory submissions
- Knowledge of electronic document management systems (eDMS) and change control processes
Precision AQ helps pharmaceutical companies get FDA-approved medicines to patients by using data, evidence, and market insights to shape access and launches. Its services combine medical science, commercial strategy, and technology development to create new pathways for drug availability and timely delivery. The company partners with drug makers to plan launches and expansion, using analytical and creative approaches to make medicines reachable and effective in real-world settings. Unlike firms that focus only on science or marketing, Precision AQ blends data-driven insights with strategic execution across development and commercialization to accelerate patient access. The goal is to raise standards in healthcare accessibility and impact by getting the right medicines to the right patients faster.
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
New York City, New York
Founded
N/A
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Simplify's Take
What believers are saying
- Precision AQ says it serves all 30 top pharma companies and launched 450-plus drugs.
- April 25, 2025 oncology hires sharpen payer, provider, and formulary strategy for launches.
- May 28, 2026 ASCO materials showcase OncoGenius and Navigator365 Matrix with 100-plus cancer centers.
What critics are saying
- IQVIA, ICON, and Syneos Health crowd Precision AQ’s commercialization niche globally.
- AI patient-services commoditization from Phluence-style tools compresses consulting margins by 2027.
- Reliance on pharma launch budgets creates existential exposure if one major client insources access strategy.
What makes Precision AQ unique
- Precision AQ’s AET has 25-plus former access decision-makers, built since 2009.
- February 17, 2026 hires Emma Hawe and Yahya Anvar deepen HEOR, AI, and EU reach.
- November 18, 2025 Phluence investment extends agentic post-Rx automation beyond traditional HUB models.
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Benefits
Health Insurance
Life Insurance
Disability Insurance
Paid Vacation
Paid Sick Leave
Parental Leave
Performance Bonus
Company News
Precision AQ, a global life sciences commercialisation partner, has appointed two senior leaders to expand its AI and data capabilities. Emma Hawe joins as Senior Vice President, Managing Director for Evidence Synthesis & Decision Modelling, bringing over 25 years of experience in evidence generation and applied statistics. She currently chairs ISPOR's HEOR Excellence—Methodology Award. Yahya Shaikh becomes Senior Vice President, Data Strategy & AI, focusing on strengthening the company's data foundation and advancing AI-enabled solutions. He brings decades of experience in AI, analytics and enterprise data strategy across life sciences and healthcare. The appointments aim to bolster Precision AQ's presence in the EU whilst expanding its global reach. The company works with all 30 top pharmaceutical firms and has launched over 450 drugs across therapeutic areas.
Precision AQ has made a strategic investment in Phluence, enhancing its post-prescription capabilities. This investment allows pharmaceutical manufacturers to virtualize patient services, reduce costs, and improve access through Phluence's advanced agentic workflow management platform. The collaboration aims to modernize patient engagement with AI-driven solutions, offering an alternative to traditional HUB models. This move supports Precision AQ's goal to streamline patient services and accelerate access to therapies.
-- Shraddha Kansagra, PharmD, BCOP, former Clinical Pharmacy Specialist at UT Southwestern, appointed Vice President, Clinical Oncology Solutions ---- Angelica Norrell, PharmD, BCOP, CSP, former Senior Director of Product at Optum, joins as Senior Director, AET ---- Courtney Patterson, PharmD, MBA, former System Director of Oncology Pharmacy Services at Advocate Health, joins as Vice President, Clinical Oncology Solutions --NEW YORK, April 25, 2025 /PRNewswire/ -- Precision AQ, a leader in life sciences commercialization and a driving force in expanding patient access to life-changing therapies, today announced the additions of Shraddha Kansagra, PharmD, BCOP, Angelica Norrell, PharmD, BCOP, CSP, and Courtney Patterson, PharmD, MBA to its Access Experience Team (AET). These experts join Precision AQ's AET, an industry-leading team of former access decision-makers and influencers, to provide critical insights to life science companies and support them in anticipating payer challenges and designing strategies to optimize patient access in oncology.As access decisions in oncology increasingly incorporate both payer and provider perspectives, the additions of Drs. Kansagra, Norrell, and Patterson reflect Precision AQ's commitment to evolving with the landscape. Precision AQ's AET boasts numerous oncology experts, including five Board Certified Oncology Pharmacists (BCOPs), from prominent payer and provider-based institutions across the United States. These new additions further bolster the AET's expertise and capabilities, including driving medical and pharmacy benefit management for Value Based Care, drug coverage policy and formulary design; optimizing patient care through quality improvement initiatives; and overseeing pharmacy and healthcare operations."We are delighted to welcome Shraddha, Angie, and Courtney to Precision AQ, bolstering our AET with additional expertise in oncology, one of the most innovative areas in healthcare," said Chad Clark, President and Chief Operating Officer of Precision Medicine Group. "Together with our existing roster of top-tier access decision makers, as well as our external network of over 100 oncology advisors from leading U.S
HITRUST i1 certification confirms Precision AQ's commitment to protecting sensitive data with leading security practices.NEW YORK, March 31, 2025 /PRNewswire/ -- Precision AQ, a leader in guiding life science organizations through the complexities of product commercialization and empowering access to life-changing medicines for all, announced today that its PatientLens platform has achieved HITRUST certification for system and information security.PatientLens transforms healthcare insights and patient program design by reducing friction in patient services and by delivering timely, actionable information to support decision-making. The platform offers a detailed view of insurance coverage, out-of-pocket costs, and medical or medication history. By leveraging tokenized patient data and advanced analytics, PatientLens helps healthcare organizations optimize patient outreach, prioritize cases, and ensure compliance, driving improved outcomes and operational efficiency.The HITRUST Implemented, 1-Year i1 validated assessment and certification process confirms that the PatientLens platform applies a robust set of HITRUST-curated controls. These controls ensure the organization follows leading security practices and maintains a comprehensive cybersecurity program to defend against cyber threats. HITRUST continuously analyzes cyber threat intelligence to keep its control requirements relevant, helping organizations mitigate emerging risks like phishing, brute force attacks, and ransomware, and supporting organizational resilience."The HITRUST i1 validated assessment is a powerful tool for cyber-aware organizations, such as Precision AQ," said Robert Booker, Chief Strategy Officer at HITRUST. "This certification assures the measurement, implementation, and performance of robust information security controls
SOUTH SAN FRANCISCO, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (Nasdaq: TNYA), a clinical-stage biotechnology company with a...