Senior Post-Market Clinical Analyst

Juul Labs

5d • Remote

About The Position

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.

Requirements

• 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.
• Bachelor’s degree in nursing required or applicable experience with current registered nurse license without restriction.

Nice To Haves

• Experience executing CAPAs is preferred.
• Intermediate to Advanced MS excel is required (Pivot tables, VLOOKUP, formulas)
• Understanding of Risk Management is preferred.

Responsibilities

• Oversee adverse experience processes related to product complaint handling, ensuring every consumer health or adverse event (AE) is managed according to company protocols.
• Gather 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.
• 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.

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
• Cell phone subsidy, commuter benefits and discounts on JUUL products
• Excellent medical, dental and vision, disability, and life insurance, plus family support, wellness, legal, and employee assistance program benefits
• 401(k) plan with company matching
• Plus biannual discretionary performance bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level