Technical Writer

Company: Talent Software Services
Location: San Rafael
Posted on: April 25, 2025

Job Description:

Partner with Global Process Owner and Process Leads to create and revise documentation to support the implementation of SAP. Redline documents and manage workflows in the document management system and provide project status updates.

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

Key Responsibilities

Create and Revise GXP Documentation: Assist in creating and revising GXP documentation (SOPs, WIs, BPDs, Forms) to support process design and validation timelines.
Create and Revise Non-GXP Documentation: Assist in creating and revising work instructions to support process design.
Manage Training and Document Change Requests: Assist in creating and managing training change requests and document change requests in Veeva and Compliance Wire.
Project Manage Workflows: Help manage workflows in Veeva Quality Document Management System and Compliance Wire to meet validation and project timelines. Provide status reports to PMO and workstreams.
JIRA Tracking: Utilize the JIRA dashboard for all documents, including linking parent/child relationships, updating comments, changing label statuses, and ensuring the dashboard is accurate.

Skills/Competencies

Proactive approach to creating and managing document workflows.
Ability to present information clearly and logically for reader comprehension.
Generate innovative ideas for content and workflow solutions.
Meet with subject-matter experts to ensure specialized topics are appropriately addressed.
Analyze information required for the development or update of policy, procedure, and form documentation.
Review and/or copyedit content developed by other team members.
Familiarity with systems such as Veeva EDMS (doc management), Compliance Wire (training), Microsoft Word, Excel, and JIRA.
Attention to detail.
Strong written and oral communication skills.
Ability to prioritize and execute tasks in a fast-paced environment.
Willingness to take on new challenges and build on current skills.
Exceptional analytical and conceptual thinking skills.
Ability to multi-task and be a self-starter.
Ability to check all technical material for consistency and accuracy.
Experience working in GMP control systems is preferred.

Key Working Relationships

Work with Document Team to ensure consistency in process and styles on all documentation.
Partner with GPO and Process Leads on content requirements resulting in new or revised documents.
Partner with Veeva Document Owners and QADC to initiate and manage document workflows.
Partner with Project Ignite PMO on program updates.

Keywords: Talent Software Services, Santa Clara , Technical Writer, Engineering , San Rafael, California