About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

Responsible for providing equal support for technical writing and product labeling coordination activities for FDA-regulated diagnostic products. This position coordinates the creation, revision, approval, and maintenance of product labeling while also developing, revising, and managing controlled quality and regulatory documentation. The role works collaboratively with Regulatory Affairs, Quality Assurance, Manufacturing, Marketing Communications, and external partners to ensure documentation and labeling are accurate, compliant, and completed according to project timelines. The position serves as a key contributor to document control, change management, and technical documentation processes within Meridian’s Quality Management System.

Key Duties

Major Duties and Responsibilities

Labeling Coordination Responsibilities (Approximately 50%)

Coordinate the creation, revision, approval, and maintenance of product labeling, labeling specifications, translations, artwork files, and associated documentation.
Prepare labeling files, label approval packages, specifications, and print-ready materials using approved software and document management systems.
Serve as the primary liaison between Meridian and contract manufacturers regarding labeling activities, ensuring timelines, approvals, and deliverables are achieved.
Collaborate with Regulatory Affairs, Quality Assurance, Manufacturing, and Marketing Communications to implement compliant labeling changes.
Maintain labeling records and ensure documentation is current, accurate, and compliant with applicable regulatory requirements and internal procedures.

Technical Writing Responsibilities (Approximately 50%)

Develop, revise, format, and maintain controlled quality, regulatory, and operational documentation including procedures, work instructions, specifications, forms, product labeling, and Instructions for Use (IFUs).
Partner with subject matter experts to gather information and translate technical content into clear, concise, and compliant documentation.
Review documentation for accuracy, consistency, readability, formatting, and compliance with company standards and regulatory requirements.
Coordinate document revisions, change control activities, and approval workflows through the electronic document management system.
Support document control processes including version management, document archival, periodic reviews, and records maintenance.
Assist with continuous improvement initiatives related to documentation, labeling processes, and quality system compliance.
Other duties as assigned.

Other Duties/Physical Requirements

Physical

Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.

Other

Ability to work on a computer including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.

Qualifications

Minimum Education or Equivalent Experience Required/Preferred

Bachelor’s degree required. Technical Communication, Life Sciences, Business, or related degree preferred.
Minimum 2 years of experience in an FDA or ISO-regulated environment.
Experience with product labeling, document control, technical writing, or regulatory documentation preferred.

Competencies Required or preferred

Ability to read, understand and follow all company SOPs and Guidelines.
Computer proficiency (Word, Excel, Adobe, Bartender and Visio).
Excellent interpersonal, organizational, written and oral communication skills.
Must be well organized and able to meet strict deadlines and perform under pressure in a fast-paced environment.
Must be able to work independently as well as collaboratively in a team setting with peers and other departments in a cross functional setting.
Must be a self-starter, detail oriented and able to prioritize and balance both workload and timelines.
Strong written communication, proofreading, and document formatting skills.
Excellent attention to detail with the ability to identify inconsistencies, errors, and gaps in documentation.
Knowledge of change control, version management, and document control practices.
Familiarity with document management systems and electronic quality management systems preferred.
Understanding of regulatory documentation requirements within FDA-regulated and ISO-regulated environments preferred.
Excellent organizational skills with the ability to manage multiple projects and deadlines.
Ability to work independently and collaboratively in a cross-functional environment.

Required Travel

% None

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*

Labeling and Technical Documentation Specialist