Job Description

Position: Medical Technical Writer

Location: Onsite in Indianapolis, 2–3 days per week

Duration: 5 months

Job Description

The Medical Technical Writer will support the Medicines Quality Organization (MQO) Quality Systems team by delivering high-quality documents within the Safety and Efficacy Quality System. This role is part of a pharmacovigilance initiative, which includes managing new process maps and overseeing documentation changes such as creation, revision, and retirement related to surveillance and case management.

This position collaborates closely with business process owners and the Quality System Sr. Principal to ensure clear, compliant, and well-maintained documentation. Responsibilities include overseeing workflows and metadata in the document control system, using Veeva QualityDocs.

Key Responsibilities

Quality Systems Document Management

• Deliver high-quality, error-free documents aligned with international English writing standards.
• Develop and maintain clear, concise procedures, tools, and resource documents using approved templates, technical writing standards, and style guides.
• Ensure content accuracy and consistency across all documents and within the quality system architecture.

Document Control

• Launch templates and manage associated metadata.
• Support MQO Quality Systems with editing, quality checks, and data integrity reviews.
• Maintain complete and accurate document control records, including revision histories, approvals, and metadata.
• Track document status, milestones, and workflows.

General Expectations

• Maintain a strong customer focus and communicate effectively.
• Manage activities proactively to meet deadlines and deliverables.

Minimum Qualifications

• Bachelor’s degree in a relevant field (e.g., technical writing or life sciences).
• Minimum 3 years of technical writing experience, ideally within pharmaceutical or biotech settings.
• Experience writing GVP documents.
• Proficiency with Veeva QualityDocs or other electronic document management systems (EDMS) preferred.
• Pharmacovigilance and surveillance experience, especially in case processing or case management workflows.
• Strong attention to detail and excellent organizational skills.

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