Description

• 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. 

• Minimum of Bachelor’s and/or Master’s degree in life sciences; PhD preferred.
• Minimum of 4 years Regulatory Writing experience in a pharmaceutical, biotech, or CRO environment; experience in oncology is desired.
• Excellent verbal communication and technical writing skills including tact and diplomacy in dealing with complex projects and teams.
• Demonstrates autonomy and has ability to negotiate and collaborate within a cross‑functional team environment.
• Demonstrates success in the preparation of clinical/regulatory documents at the individual document and submission level.
• In-depth knowledge of industry regulations, guidance, and regulatory documentation requirements including thorough knowledge of ICH guidelines.
• Experience interacting and communicating timeline expectations with cross functional study team members. 
• Expert/highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint. 
• Experience with Veeva Vault and/or other document management systems. 
• Familiarity with statistical analysis concepts and techniques preferred.

This role can be based at our Hayward or Brisbane, CA locations or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000-$185,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. 

 Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets