Radiant Systems Inc · 3 hours ago
Senior Technical Writer
Plainsboro, NJ
Contract
Onsite
Senior Level
$65/hr - $73/hr
7+ years expRadiant Systems Inc is seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement. This role will emphasize the development of procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also producing training materials and job aids.
CRMInformation TechnologySoftware
Responsibilities
Lead a multidisciplinary team of subject matter experts, business process owners, and key stakeholders in the development, revision, enhancement, implementation, and maintenance of process and procedural documentation
Plan and manage multiple process development projects simultaneously, ensuring timely delivery of targeted outcomes
Create and write content for training programs, including user-friendly training materials and job aids that support process understanding and application
Utilize your knowledge of global regulations within a GxP environment to create processes and related documentation that adhere to regulatory requirements, support corporate compliance, and are inspection-ready
Contribute to compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards
Evaluate global procedural documentation against evolving industry and regulatory requirements, audit/inspection findings, and corporate policies; recommend changes as necessary based on feedback, trends, and best practices
Qualification
Required
Pharma Industry Experience
Experience w/GxP documentation required (not GMP)
SOP Writing expertise
Patient Safety knowledge/experience (HUGE PLUS)
Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable
Minimum 7+ years of experience in the design and documentation of pharmaceutical business processes and change management required
GxP environment experience required; pharmacovigilance (PV) experience preferred
Technical Writing: Background in pharmaceutical technical writing and development of Standard Operating Procedures (SOPs) is essential
Organizational Skills: Strong organizational abilities, planning, and multitasking skills; capable of prioritizing multiple projects while meeting tight deadlines
Adaptability: Ability to work effectively under pressure and adapt to changing situations with attention to detail
Technical Proficiency: Proficient in common desktop tools, including MS Word, MS Excel, MS Project, and Visio and PowerPoint
Preferred
Degree or professional certification in process design or change management is a plus
Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids
Project Management Skills: Proven ability to manage multiple projects simultaneously; PMP certification is an advantage
Experience in a GxP environment; PV experience preferred
Strong project management skills with a proven ability to manage multiple projects simultaneously; PMP certification a plus
Ability to create training materials and job aids that facilitate process understanding and implementation
Proficiency in using Visio for process mapping and diagram creation
Sharepoint and MS Teams and Forms a plus
Company
Radiant Systems Inc
Radiant Systems, Inc. is a certified Minority Business Enterprise, a Global Consulting company founded in 1995.
501-1000 employees
H1B Sponsorship
Radiant Systems Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)
Funding
Current Stage
Late StageLeadership Team
Rayn Kamesh
Head of Sales/Director, Strategic Partnership - MSP/VMS Accounts
Company data provided by crunchbase