Our client is currently seeking a Lead Analyst, R&D Technical Writing

Job Description – Clinical Documentation & Labeling Specialist

Overview

This role is responsible for the timely development, review, and completion of clinical and technical documentation, including reports, summary documents, package inserts, IFUs, and product labels. The position requires independent judgment, professional expertise, and strong attention to detail to ensure compliance with regulatory standards and support product lifecycle management.

Key Responsibilities

• Develop, edit, and finalize clinical reports, summary documents, package inserts, IFUs, and other technical documentation.

• Oversee electronic regulatory submission processes and ensure compliance with FDA, EU MDR, and other global standards.

• Provide recommendations for documentation formats, templates, and guidelines; ensure consistency across clinical and pre-clinical documents.

• Guide and support cross-functional teams in the preparation of technical and regulatory documents.

• Plan and manage timelines for document development, review, and submission to meet project milestones.

• Lead remediation of IFUs and labels to align with EU MDR regulations and standards, including CE Mark removal.

• Create and manage redline edits using Adobe tools.

• Update IFUs within DITA XML and content management platforms (preferred: Arbortext/Windchill).

• Update product labels within labeling design systems (preferred: Prisym GLS).

• Manage change control activities within PLM systems (preferred: Oracle Agile).

Qualifications

• Bachelor’s degree (or equivalent) in a relevant field.

• Minimum of 4+ years of experience in clinical documentation, regulatory writing, or technical documentation.

• Strong knowledge of EU MDR regulations, FDA requirements, and product lifecycle management.

• Proficiency in Adobe Acrobat, XML-based content management systems, and PLM tools.

• Attention to detail and ability to make evaluative judgments based on factual analysis.

• Ability to work independently with minimal supervision while managing multiple priorities.

This rewritten version makes the JD more professional and recruiter-friendly by:

• Separating responsibilities and qualifications.

• Using action-oriented language (develop, oversee, lead, manage).

• Highlighting tools and systems (Adobe, Arbortext/Windchill, Prisym GLS, Oracle Agile) in context.

• Keeping the regulatory focus (EU MDR, CE Mark, FDA compliance) front and center.

Would you like me to also reframe this JD into a résumé-ready bullet list

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