Senior Post-Market Clinical Analyst

Juul Labs's mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.

We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career is compelling, read on for more details.

JUUL Labs is seeking a Senior Post-Market Clinical Analyst to join our Quality department. In this role, you will oversee adverse experience processes related to product complaint handling, ensuring every consumer health or adverse event (AE) is managed according to company protocols. You will be responsible for gathering comprehensive information from consumers and other necessary sources to facilitate accurate documentation, thorough investigation, and the determination of SAE/UAE reporting requirements through to closure. Responsible for timely escalations of all adverse experience complaints.

• →Able to assess complaints to determine if a report needs to be filed based on various global regulatory requirements.
• →Responsible for on-time (15 day) submissions of SAE/UAE adverse experience supporting market authorization to FDA.
• →Conducts comprehensive clinical evaluations for cases involving litigation. This responsibility entails the review and interpretation of medical records to produce detailed clinical summaries. These summaries must be technically precise and based strictly on the documented medical history to provide an objective clinical overview of the case.
• →Create a positive experience when collaborating externally with direct consumers of any JUUL Labs device(s), medical professionals, and customers to capture accurate product and event information pertinent to investigations.
• →Partners with team members in performing rigorous daily and weekly surveillance reporting to monitor complaint lifecycles and evaluate new incoming data to maintain timeliness. Performs auditing of complaints to ensure critical to quality fields are documented appropriately.
• →Able to work cross functionally with various departments including Customer Operations, Regulatory, Medical and Scientific affairs, Legal and Engineering.
• →Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards.
• →Responsible for communicating complaint-related issues or opportunities to next management level as well as other internal departments (e.g., Marketing, R&D, Customer Operations)
• →Responsible for providing post market quality data in support of an information request from a regulatory authority, root cause investigations, and new product development.
• →Maintaining and updating current Post Market quality system policies and procedures
• →Support internal and external audits.
• →Periodic domestic and international travel may be required.

• Minimum 2-5 years of experience in a medical device, pharmaceutical or tobacco Post Market Surveillance environment.
• Experience with receiving, evaluating, and investigating complaints.
• Experience with submitting Adverse Event Reports to FDA and/or other Health Authorities.
• Experience with Notified Body and Health Authority Inspections.
• Strong analytical and problem-solving skills
• Excellent written and oral communication skills required.
• Intermediate to Advanced level MS Office (Word, PowerPoint, Excel) skills required.
• Strong interpersonal skills: ability to interact with individuals and groups at all levels.
• Strong presentation/training skills required.
• Must be able to manage multiple tasks and perform with accuracy and high attention to detail.
• Strong organizational skills, time management skills, and ability to manage in a complex/time sensitive environment.
• Experience executing CAPAs is preferred.
• Intermediate to Advanced MS excel is required (Pivot tables, VLOOKUP, formulas)
• Understanding of Risk Management is preferred.