Job Details

Technical Writer/Procedure Document Specialist

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. 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.

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:

• 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.

Required Skills

• Project Management Skills
• Proven ability to manage multiple projects simultaneously.
• PMP certification is an advantage.
• Technical Writing
• Background in pharmaceutical technical writing.
• 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:

• MS Word
• MS Excel
• MS Project
• Visio
• PowerPoint
• SharePoint, MS Teams, and Forms are a plus.
• Knowledge and usage of training tools such as:
• Articulate Storyline
• Rise
• Synthesia (plus)
• Experience with LMS systems and compliance reporting.
• Communication Skills
• Strong verbal and written communication skills.
• 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 is 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 keen attention to detail.

Top Skills / Experience Per Manager:

• Pharma Industry Experience
• Experience with GxP documentation required (not GMP)
• SOP Writing expertise
• Compliance Training design and development experience (plus)
• Patient Safety knowledge/experience (huge plus)

About US Tech Solutions US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. AI Statement By applying, you acknowledge that AI-assisted tools may be used during the hiring process.