JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.
We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.
ROLE AND RESPONSIBILITIES:
JUUL Labs is searching for a Principal Analyst, Global Post Market Quality, to join our Quality Team. They will be responsible for analyzing customer complaints to determine which are regulatory reportable and will be a key contact for activities with internal, field, and end use customers. Responsible for adherence to, and interpretation of, Good Manufacturing Practices (GMPs), and complaint handling per the Code of Federal Register (CFR). Communicates event investigation results via regulatory reports and written communications, as appropriate.
- Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations. Experience with Health Hazard Evaluations is required.
- Serves as internal consultant on regulatory issues, field actions, and report decision-making. External government contact person, in addition to writing, reviewing, and auditing departmental Regulatory reporting, ensuring timely transmission to the appropriate regulatory authorities.
- Is an expert in clinical settings related to product application; evaluates identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. MedDRA coding experience is preferred.
- Drives regulatory reporting decisions using event investigation and regulatory decision models. Writes and develops decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations.
- Develop and deliver presentations to global regulatory agencies. Topics may include regulatory reporting strategies, compliance issues, or new initiatives.
- Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to internal and external stakeholders.
- Is an expert on the Global Post Market staff serving as a resource to promote development of team through helping think out processes, look up information, and direct guidance. Department mentor/trainer.
Quality System Requirements:
In all actions, demonstrates a primary commitment to consumer safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions.
Planning and Organization:
Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones.
Discretion/Latitude; Supervision Received; Decision Making:
Works without appreciable direction. Works independently on highly specialized projects with long range objectives. Exercises considerable latitude in determining objectives of assignment. Selects methods and techniques to lead a project to completion. Develops departmental policies and procedures, new techniques and standards. Work is reviewed from a relatively long- term perspective, for desired results.
Guides the successful completion of major programs and often functions in a project leadership role. Effects of decisions are long-lasting and influence the future course of the organization. Errors in judgement or failure to achieve results would result in the expenditure of large amounts of company resources.
Serves as a consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, projects, or objectives. Uses diplomacy and tact to diffuse high tension situations, particularly with senior level internal and external contacts. Occasionally escalates the most serious issues to manager.
Participates in the development of others by facilitating training and providing feedback and guidance.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- At least 10-15 years of professional/ managerial experience required.
- Holds a combination of generalist experience and expertise in a specialized field. Applies comprehensive knowledge of a particular field to resolve complex issues in creative ways. Full knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships.
- Strong relationship building and project management skills
EDUCATION: Current Registered Nursing license and Bachelor’s Degree 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
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits