Technical Writer/Procedure Document Specialist IV

Job Title: Technical Writer/Procedure Document Specialist IV

Location: PLAINSBORO, NJ

Salary Range: $74.70/hr

Introduction

We are seeking a skilled professional 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 needed.

Required Skills & Qualifications

• 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.
• Background in pharmaceutical technical writing and development of Standard Operating Procedures (SOPs) is essential.
• Proven ability to manage multiple projects simultaneously; PMP certification is an advantage.

Preferred Skills & Qualifications

• Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids.
• Proficiency in using Visio for process mapping and diagram creation.
• Experience using common AI tools to optimally improve concise and clear communications.

Day-to-Day 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.

Company Benefits & Culture

• Competitive compensation package.
• Opportunities for professional growth and development.
• Collaborative and inclusive work environment.

For immediate consideration please click APPLY to begin the screening process with Alex.