Cynet Systems · 5 days ago
Senior Technical Writer/Procedure Document Specialist
Plainsboro, NJ
Full-time
Onsite
Senior Level
$67.23/hr - $72.23/hr
7+ years expCynet Systems is seeking a Senior Technical Writer/Procedure Document Specialist who will lead the development and maintenance of pharmaceutical process documentation in a regulated GxP environment. This role involves collaborating with cross-functional teams to ensure documentation supports compliance and effective business operations.
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Responsibilities
Lead multidisciplinary teams of subject matter experts, business process owners, and stakeholders in developing, revising, implementing, and maintaining process and procedural documentation
Plan and manage multiple process development projects simultaneously to ensure timely delivery of outcomes
Create and write training materials, job aids, and user-friendly content to support process understanding and application
Develop processes and documentation aligned with global regulations in a GxP environment to support compliance and inspection readiness
Contribute to compliance and audit or inspection readiness strategies and plans
Evaluate global procedural documentation against regulatory changes, audit findings, and corporate policies
Recommend and implement documentation updates based on feedback, trends, and best practices
Qualification
Required
Experience working in a GxP regulated environment
Background in pharmaceutical technical writing, including development of Standard Operating Procedures
Strong project management skills with the ability to manage multiple initiatives simultaneously
Minimum of seven years of experience in pharmaceutical business process design, documentation, and change management
Experience in process training development, delivery, or implementation
Pharmacovigilance experience preferred
Pharmaceutical technical writing and SOP development
Project management and multitasking in regulated environments
Process mapping and diagram creation using Visio
Development of training materials and job aids
Strong organizational, communication, and analytical skills
Proficiency in MS Word, Excel, Project, PowerPoint, and Visio
Bachelor's degree required
Preferred
Pharmacovigilance experience preferred
Advanced degree in a relevant field preferred
Degree or professional certification in process design or change management preferred
PMP certification a plus
Experience with SharePoint, MS Teams, and Forms preferred
Company
Cynet Systems
Headquartered in Washington DC Metro Area, Cynet Systems is a top talent supplier for companies across North America.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashwani (Ash) M.
Partner and Co-CEO
Nikhil "Nick" Budhiraja
Founder / Co-CEO
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