Senior Post Market Clinical Analyst

    • San Francisco, CA

THE COMPANY:

JUUL Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. 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 at one of the fastest growing companies is compelling, read on for more details.

ROLE AND RESPONSIBILITIES:

JUUL Labs is searching for a Senior Post Market Clinical Analyst to join our Quality team. The Senior Post Market Clinical Analyst will be responsible for maintaining the health event processes associated with product complaint handling to ensure that all complaints involving a consumer health event or adverse event are handled in accordance with established company procedures. This individual will seek to obtain adequate information from the consumer and whatever other resources necessary to ensure proper documentation, investigation, and closure of each health event/adverse event.

  • Responsible for timely escalations of all health event and adverse event issues
  • Create a positive experience when working externally with direct consumers of any JUUL Labs device(s), medical professionals and customers to capture accurate product and event information pertinent to investigations
  • Evaluate all information from a clinical, procedural and technical perspective to ensure appropriate analysis is available to internal stakeholders for Quality/Failure Analysis, investigation, root cause, or Quality Engineering review. Applies standard practices and techniques in specific situations, adjusts and correlates data, recognizes discrepancies in results
  • Provide detailed clinical input into all Health Hazard Evaluations
  • 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 root cause investigations, and new product development
  • Maintaining and updating current Post Market quality system policies and procedures
  • Support internal and external audits
  • Run daily/weekly reports to track progress of activities and to review new incoming information for any changes to reportability of a complaint

 

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

  • Minimum 6-10 years of experience in a medical device/Post Market Surveillance environment
  • 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 a high attention to detail
  • Strong organizational skills, time management skills and ability to self-manage in a complex/time sensitive environment
  • A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics
  • Prior experience in the medical device industry or an FDA regulated environment is required
  • Demonstrated ability to identify issues in post-market surveillance complaints is preferred
  • Experience executing data management tasks and working with complaint investigations, root cause analysis, identification and implementation of CAPAs are preferred
  • Intermediate to Advanced MS excel is required (Pivot tables, VLOOKUP, formulas)
  • Experience with analysis and signal detection in a large data set is preferred
  • Understanding of Risk Management is preferred. Experience with electronic Complaint Management System and technical documents is preferred

EDUCATION: Bachelor’s Degree in Nursing required, Master’s Degree preferred

JUUL LABS PERKS & BENEFITS:

  • A place to grow your career. We’ll help you set big goals - and exceed them
  • People. Work with talented, committed and supportive teammates
  • Equity and performance bonuses. Every employee is a stakeholder in our success
  • Boundless snacks and drinks
  • Cell phone subsidy, commuter benefits and discounts on JUUL products
  • Excellent medical, dental and vision benefits
JUUL Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment 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. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. JUUL Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for JUUL Labs in the US.


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