Medical Safety Writer Job at Medasource in Indianapolis

Position: Medical Technical Writer

Duration: 12+ months

Job Description:

The Medical Technical Writer is responsible for supporting Medicines Quality Organization (MQO) Quality Systems team to deliver high quality documents in the Safety and Efficacy Quality System. The Technical Writer will support a pharmacovigilance initiative where new process maps have been created and document changes include new documents, retirement, and revisions within the pharmacovigilance system around surveillance and case management processes. This role works closely with the business process owners and the Quality System Sr. Principal.

The Technical 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. Correct errors in grammar, style, formatting, and syntax.
• Verify quality system architecture accuracy and consistency of content within and between related documents.

2. 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 & associated documentation throughout the workflow.

General expectations:

• Maintain a strong customer focus.
• Communicate effectively.
• Manage activities efficiently and proactively to achieve timelines.

Minimum Qualifications:

• Bachelor’s degree in a relevant field, such as technical writing or life sciences
• 3+ years of experience in technical writing for procedures (pharmaceutical or biotech environment preferred)
• Writing GVP Documents
• Experience using Veeva QualityDocs or other electronic document management systems (EDMS) preferred
• Pharmacovigilance/ Surveillance experience
• Case processing/case management workflow