Job description

WHY WORK FOR ARCTURUS?
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global, late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis, along with partnered programs including glycogen storage disease type III, and hepatitis B virus. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations including, amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis Foundation.
Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients.
THE OPPORTUNITY
This role is responsible for providing support for Veeva Vault applications. The successful applicant must have a solid understanding of Veeva Vault (any experience with eDMS, QualityDocs, eTMF, RIM). This is a power user type of role, with some level of functional understanding of the implemented design, leveraging project and process support documentation and resources. Candidate must be self-directed, be a great team player and have excellent communication skills. Candidates who have experience in life sciences or FDA regulated industries is preferred. The Veeva Vault System Administrator will ensure adherence to relevant regulatory requirements (e.g. 21 CFR Part 11 / EU Annex 11) and company Standard Operating Procedures (SOPs) as appropriate.
WHAT YOU WILL CONTRIBUTE

• Act as a Veeva Vault System Administrator
• Support of end user Incidents
• Extensive knowledge of document management systems (document lifecycles, workflows, user access & permissions)
• Knowledge of Veeva Vault Platform
• Familiarity with any of the following:
• Quality business processes, such as electronic document management systems, document lifecycles, and / or change control, CAPA, Deviation business processes
• Clinical business processes, such as electronic Trial Master File (eTMF) and / or clinical trial management systems (CTMS)
• Regulatory business processes, such as submissions, applications and / or registrations
• Medical material

• Ad hoc data loads using Vault Loader as per business needs
• Change Management processes and Good Documentation Practices
• Vault Reporting capabilities
• Veeva certifications desired
• Respond to requests for power user support and be available to address Tier 1 support (process support, master data, user access, user support and other non-technical issues)
• Maintain current knowledge base of solutions and work with Tier 2 and 3 support sustainment teams to facilitate technical break / fixes
• Ability to prioritize and juggle multiple concurrent projects and day-to-day requests.
• Strong and effective verbal and written communication skills
• Strong interpersonal, teamwork and customer interfacing skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.

WHAT WE SEEK

• Bachelor's degree in Computer Science, Information Systems and or other related fields
• A minimum of 3 years in a pharmaceutical, biotechnology or other regulated environment OR equivalent experience and/or education
• 3+ years of relevant Veeva Vault System Administrator experience
• Advanced skill level with Microsoft Office, especially Excel, Word, PowerPoint, and Outlook.
• Detail oriented with strong analytical, written, verbal communication and interpersonal skills
• Strong background in Good Documentation Practices is required. Ability to work well under pressure, independently, multi-task, and have good time management skills

WHAT WE OFFER
An exciting opportunity to join a company that offers:

• Catered lunches
• Free variety of snacks and beverages
• Referral Bonuses
• On Campus Gym
• Company sponsored FUN events

For a deeper dive into our company and corporate culture visit www.ArcturusRx.com
Arcturus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Job Type: Contract

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