Sr. Document Specialist

Description

Job Title: Senior Document Specialist - Remote

Primary Function

The Senior Document Specialist is responsible for providing document Quality Control (QC), formatting, and Regulatory Operations support in compliance with company and global regulations, including International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP). The Document Specialist will work cross-functionally with internal departments, including Medical Writing (MW), Regulatory Operations, and Regulatory Chemistry Manufacturing and Controls (CMC) to edit, format, and support regulatory documents.

Key Responsibilities

• Ensures appropriate communication on project and program-related matters requiring document QC and/or coordination.

• Performs detailed QC review of regulatory, clinical, and nonclinical documents.
• Performs limited QC review of CMC documents.

• Coordinates QC reviews of documents (whether performed internally or through a vendor) and maintains audit trails of changes.

• Verifies content to ensure accuracy of all statements within document text compared to source data and references.
• Interprets clinical data and literature as needed to perform QC duties.
• Proofreads or substantively edits documents to correct and streamline grammar, spelling, punctuation, style, and format.
• Provides formatting, consistency checks, and abbreviations checks for documents.
• Verifies that document content is consistent with internal and regulatory guidelines.
• Formats, styles, and troubleshoots functionality of documents and templates.
• Ensures consistency of key messaging within and between submission documents.
• Ensures compliance of document formats per templates and style guide.

• Requests literature references and ensures references are added to a Veeva repository and cross-checked against documents (as applicable).
• Works with cross-functional teams to perform literature searches in support of regulatory and commercial needs.
• Launches documents for review/approval within Veeva and finalizes Veeva reviews.
• Coordinates collection of clinical study report (CSR) Section 16 appendices.
• Uploads CSR Section 16 appendices to appropriate binders in Veeva.
• Delivers projects on-time and to the highest standards of quality.

Qualifications and Education

• Minimum of Bachelor's degree in the life sciences.
• Minimum of 2 years of experience in a pharmaceutical, biotech, or CRO environment.
• Expert word processing skills in MS Word, including proficiency with hyperlinking, bookmarking, tables, graphs, and figures.
• Must be able to work in a collaborative team environment.
• Strong computer skills, project management skills, and a high attention to detail.

• Excellent understanding of ICH and GCP guidelines and regulations.
• Knowledge of SharePoint, internet software, spreadsheet software, word processing software, graphics software (e.g., PowerPoint), bibliographic software, and any other applicable software as may be needed.
• Must demonstrate strong experience in relationship-building and effective team collaboration.
• Familiarity with infrastructure software, such as Veeva RIM and eCTD submissions a plus.

• Familiarity with Food and Drug Administration (FDA) Document Specifications for publishing a plus.

This role is remote based. The anticipated salary range for fully qualified candidates applying for this position is $115,000 - $145,000 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

#LI-Remote

#LI-JC1