Technical Writer/Procedure Document Specialist IV

Job Title: Technical Writer/ Consultant/Procedure Document Specialist IV
Location: Plainsboro, NJ 08536 OR Remote (preference will be given to local candidates)
Duration: 6 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
• Compliance Training design and development experience a plus
• Patient Safety knowledge/experience (HUGE PLUS)

Job Summary:

• The client 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 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.
• This role will have some flexibility to work with other teams within our training and documentation team as needed.
• Assist with Vendor training and oversight as well as needed.

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. Knowledge and usage of training tools such as Articulate Storyline, Rise, and Synthesia (a plus) Experience with LMS systems and compliance reporting
• 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 or pharma experience preferred
• Experience using common AI tools to optimally improve concise and clear communications
• 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