Lead Analyst, R&D Technical Writing

Our client is currently seeking a Lead Analyst, R&D Technical Writing for a 12 month + contract.

Assists in the timely development and completion of clinical reports, summary documents, package inserts and other documents. May oversee the electronic regulatory submission process.

Oversees and provides recommendations for the development of formats and guidelines for documentation. Provides guidance and direction for completion and development of clinical and pre-clinical documents.

Ensures effective planning and management of timelines for all aspects of technical documents.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.

This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent.

The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive.

The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 4 or more years experience.

Primary focus on the remediation of IFUs and labels to the latest regulation and standards for electronic IFUs. IFU remediation may require conversion of the IFUs from Adobe source files to DITA xml within a content management platform (preferred experience: Arbortext/Windchill), and updates to the content.

Label remediation may include creating new label templates and the creation of new labels in Prisym and Adobe platforms.

Other tasks may include creating documentation demonstrate compliance to the latest regulation and standards for electronic IFUs, creation of part numbers and change management.