Clinical Records (eTMF) Management Specialist
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 looking for a Clinical Records (eTMF) Management Specialist to join our Quality Systems team. In this role, you will partner with our Clinical & Medical Operations teams in managing the eTMF Veeva Vault system. You will also be responsible for ensuring overall company compliance with GCP and GLP records management procedures and training programs.
- Position will be accountable for implementing and managing electronic file tracking and filing systems, and for assuring that global study documentation and training records are stored and maintained according to applicable JUUL policies and regulatory requirements
- Maintain extensive knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation, preclinical study records and Development Operations documentation
- Support the implementation of procedures for the establishment, security, and maintenance of the eTMFs for clinical studies, preclinical and bioanalytical records
- Process records (e.g., track, scan, archive) in compliance with JUUL SOPs
- Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records
- Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 2-3 years of experience working in experience in an FDA regulated environment: pharmaceutical, medical device or equivalent industries
- Extensive knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GLP and GCPs governing the maintenance of clinical records (eTMF)
- Strong communication and influence skills and ability to create a clear sense of direction is necessary.
- Excellent attention to detail, sound judgment, and ability to work independently under pressure
- Ability to prioritize tasks and deliver assignments with high quality in a timely manner
- Strong interpersonal skills; Ability to build strong relationships and positively motivate others
- Excellent verbal, written, interpersonal and presentation skills are required.
- Ability to examine functional issues from a broader organizational perspective and create global strategy.
- Veeva Vault eTMF experience preferred
- Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
EDUCATION: Bachelor’s Degree, or equivalent experience
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
- Location. Work in the heart of San Francisco, one of the world’s greatest cities
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