Job Title: Technical Writer/Procedure Document Specialist IV
Location: Plainsboro, NJ 08536
Duration: 12 Months (Possibility of extension depending upon business requirements and performance)
 
Top Skills Per MGR:

• Pharma Industry Experience
• Experience w/GxP documentation required (not GMP)
• SOP Writing expertise
• Patient Safety knowledge/experience (HUGE PLUS)

 
Job Summary:

• We are seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement within the CMR Strategic Operations, GxP Compliance & Technical Operations.
• 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.

 
Key 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.

 
Qualifications:

• Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management is a plus.
• Experience: Minimum 7+ years of experience in the design and documentation of pharmaceutical business processes and change management required.
• Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids.
• GxP environment experience required; pharmacovigilance (PV) experience preferred.
• Project Management Skills: Proven ability to manage multiple projects simultaneously; PMP certification is an advantage.
• 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.  Sharepoint and MS Teams and Forms a plus.
• Communication Skills: Strong verbal and written communication skills with an in-depth understanding of pharmaceutical business processes, regulations, guidelines, and industry standards relating to compliance.

 
Critical Skills/Experience:

• 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 
• Background in pharmaceutical technical writing, specifically Standard Operating Procedures (SOPs) 
• Ability to create training materials and job aids that facilitate process understanding and implementation 
• Proficiency in using Visio for process mapping and diagram creation.
• Ability to work on critical initiatives under pressure while maintaining a keen attention to detail.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.00/hr.