Arcus Biosciences

QA Engineer

• Work with study management teams to facilitate adherence to Quality and Regulatory Compliance
• Ensure conformance to domestic and international quality regulations and GCP guidelines
• Participate in day-to-day QA Compliance operations
• Provide GCP compliance oversight and support to Arcus Clinical Development therapeutic areas
• Provide expertise regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements
• Support the management of study-specific deviations/events/CAPAs in the GCP/PV space
• Collaborate with CRO quality counterparts
• Participate in internal and external GCP audits
• Maintain up to date audit results in Arcus electronic quality management system (Veeva Quality Vault, preferred)

Associate Director, CQA

Compliance

• Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success
• Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets
• Represents the regulatory function on cross-functional development teams
• Plans, prepares, and reviews submissions to regulatory authorities including FDA, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications
• Works with regulatory submissions coordinator to develop submission timelines and work with cross-functional teams to planned objectives
• Serves as the primary point of contact with FDA and other health authorities as applicable
• Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of interaction
• Manages all maintenance plans for regulatory investigative and marketing applications for assigned projects
• Manage and provide guidance/training for regulatory staff members, including regular feedback and coaching for professional development
• Develop relationships with external partners
• Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs
• Provides regulatory guidance and/or training to external departments
• Prepares and revises internal procedures for continuous improvement
• Manages activities performed by regulatory

Senior Director, Regulatory Affairs

Medical writer

• Independently prepares, edits, and finalizes Protocols including amendments, addenda, and notes to file, original and updated Investigator’s Brochures, Clinical Study Reports (full and abbreviated), as well as other regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, Briefing Books) with minimal input.
• Coordinates and leads comment adjudication meetings.
• Develops, manages, and communicates project timelines.
• Ensures appropriate and effective collaboration with key functional contributors and adherence to ICH and other regulatory requirements, in addition to internal Arcus document standards.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and to align key messaging for CSR and submission document development.
• Serves as MW point-of-contact to internal cross functional teams and Arcus partners in support of medium-to-large development programs and initiatives.
• Participates in MW and cross-functional process improvement initiatives on clinical document standards, template development, and document or MW processes.
• Reviews documents written by less experienced or contract medical writers.
• Coordinates Quality Review (QR) of documents, addresses comments, and maintains audit trails of changes.
• May perform QR review if requested (eg, QR in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc).
• Coordinates communication with document processing and ensures template formatting aligns with Arcus quality standards.
• May provide oversight of vendors, vendor resources, and contracts.

Associate Director, CQA

Senior Director, Regulatory Affairs

Principal Medical Writer