About us:
Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.
We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written.
Job Summary:
The Regulatory Operations Associate Director is responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations Function at Arcus and help to establish an approach for regulatory submissions.
This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for the US. This person will collaborate closely with other Regulatory teams to establish the Regulatory Operations department. This person will manage the Publishing, Document Processing, and Archiving Functions.
Job Responsibilities:
Regulatory Operations Duties
- As the lead of the Regulatory Operations team, helping to establish the team and the sub functions within Arcus.
- Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers.
- Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions.
- Lead strategic processes and provides strategic value to the overall positioning of the department with Arcus
- Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services.
- Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Arcus regulatory dossiers
- Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications.
- Interacts frequently with other functional areas such as IT, Clinical Operations, and Regulatory. Maintains constructive and positive interactions with colleagues.
- Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects.
- Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution.
- Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts.
- Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities.
- Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content.
- Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures such as StartingPoint document templates, best practice for use in the Veeva Vault RIM platform and eCTD Viewing in Rosetta Viewer.
- Maintain a compliant and up-to-date Regulatory Archive using Veeva Vault Archive.
- Develop and training on archiving process as necessary
- Lead the development and management of projects as applicable in support of the Regulatory Operations department.
- Manage and develop junior members of staff.
Management Duties
- Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings.
- Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate.
- Manage vendor relationships including required resources, issue resolution and contract negotiation.
Qualifications (including knowledge & skills):
Minimum education and experience level
10+ years of relevant experience and a BA or BS or 8+years with Master or above
Preferred qualifications
- Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.
- Management experience is preferred.
- Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
- Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required
- Experience with archive management
- Experience with vendor management is a plus
- Strategic thinking is required, with a focus on process improvement and optimization.
- Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.
- Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers' expectations.
- Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations.
- Familiarity with pharmaceutical development and global Regulatory submissions is required.
- Organized with systematic approach to prioritization
- Process orientated to achieve the business objective
- Ability to learn new technologies quickly