Job Title: Technical/Medical Writer

Location: Indianapolis, IN

Duration: 12 months

Start Date: ASAP

Job Description:

The technical writer will be supporting the client's Medicines Quality Organization team to deliver high quality documents in the Safety and Efficacy Quality System. The medical writer will support document changes within the Safety and Efficacy Quality Systems, working closely with colleagues in the Quality Systems, Global Patient Safety, and other components of the Research and Development organization.

The writer is responsible for developing and maintaining accurate, clear, and concise procedures, required tools, and resource documents. The role is also responsible for quality checks of the quality system documents to ensure compliance with the client's standards and procedures. The role manages workflows and metadata in the document control system using Veeva QualityDocs.

Job Responsibilities:

1.) Quality Systems Document Management

• Ensure timely delivery of error-free, high-quality documents that meet international standards of written English
• Develop and maintain accurate, clear, and concise procedures, required tools, and resource documents using appropriate technical writing standards templates, and style guides
• Verify quality system architecture accuracy and consistency of content within and between related documents
• Document Architecture
• Design and implement document architecture for Safety and Efficacy Quality System safety documents (procedures, required tools and resource documents), ensuring clarity, coherence, and adherence to regulatory requirements
• Document Control
• Launch templates and manage document metadata
• Support MQO Quality Systems with editing, Quality Checks, and data integrity review
• Ensure the accuracy and completeness of document control records, including document revision histories. revisions, approvals, and related metadata
• Track status, milestones, and associated documentation throughout the workflow
• General Expectations
• Maintain a strong customer focus
• Communicate effectively
• Manage activities efficiently and proactively to achieve timelines
• Cross-functional collaboration: work closely with the Global Patient Safety Team to gather information and incorporate feedback into the Safety & Efficacy Quality System document development
• Timeline management: develop and manage timelines for document creation, ensuring timely completion and delivery of high-quality documents
• Maintain proficiency in applicable software, tools, processes, and workflows

Requirements:

• Understanding of routine medical writing / surveillance activities
• 3+ yrs direct experience with medical writing
• Pharma/industry experience is a plus
• Pharmacovigilance/Safety experience a huge plus
• Ability to draft and control document flow for process owner
• Experience using Veeva QualityDocs and electronic document management systems
• Ability to work cross-functionally between safety, regulatory, clinical teams