Joulé · 22 hours ago
R&D Technical Writing Lead Analyst
United States
Contract
Remote
Mid, Senior Level
$38.67/hr - $45.33/hr
4+ years expJoulé is a global medical device company looking to hire an experienced Technical Writer to join their team. The Technical Writer will be responsible for developing, standardizing, and maintaining clear and accurate documentation including operating procedures, work instructions, and forms.
Staffing & Recruiting
Responsibilities
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
Primary focus on the remediation of IFUs and labels to latest EU MDR regulations and standards, CE Mark removal, and activities supporting product lifecycle management
Leads redline creation in Adobe
Leads IFU updates within DITA xml & content management platform (preferred experience: Arbortext/Windchill)
Leads label updates within labeling design system (preferred experience: Prisym GLS)
Leads change control activities in PLM system (preferred experience: Oracle Agile)
Qualification
Required
BS Degree Required
Minimum of 4 or more years experience
Preferred
Experience with Arbortext/Windchill, Prisym GLS, and Oracle Agile highly preferred
Benefits
Health and welfare benefits coverage options
Medical
Dental
Vision
Spending accounts
Life insurance
Voluntary plans
Participation in a 401(k) plan
Company
Joulé
At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase