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Medical Writing Operations

Integrated Resources, Inc

Raleigh, NC

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JOB DETAILS
SKILLS
Artificial Intelligence (AI), Biotech and Pharmaceutical, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Communication Skills, Continuous Improvement, Cross-Functional, Document Management, Documentation, Documentation Standards, ICH Regulations, Industry Standards, Medical Office Administration, Medical Writing, Microsoft Product Family, Microsoft Visio, Operations Processes, Organizational Skills, People Management, Procedure Implementation, Quality Control, Quality Management, Regulations, Regulatory Requirements, Sales/Support Engineering (SE), Standard Operating Procedures (SOP), Traceability, Training/Teaching, Writing Skills
LOCATION
Raleigh, NC
POSTED
1 day ago
Please note: Need to use your own equipment as per company policy

Part time - 20 hrs per week
Must be online for meetings
Hybrid working;40%

Primary Purpose / Regulatory Responsibilities:
The Medical Writing Operations Specialist provides operational, process, and standards support to Global Medical Writing within Global Clinical Sciences & Operations (GCSO). The role supports the development, maintenance, and continuous improvement of medical writing SOPs, clinical standards, templates, and related training materials, ensuring inspection readiness and alignment with regulatory and industry standards.

This role focuses on standards implementation, SOP lifecycle support, process mapping, and enablement activities, working cross functionally to support compliant, efficient, and harmonized medical writing operations. The role may be fulfilled by internal staff or external contractors and does not include direct people management responsibilities.

Responsibilities
SOP & Standards Lifecycle Support
" Support the authoring, maintenance, and updating of SOPs, standards, and controlled documents relevant to medical writing.
" Support SOP lifecycle activities including impact assessment, readiness planning, implementation support, and inspection preparedness.
" Maintain alignment with internal governance, regulatory requirements, and industry standards (e.g., TransCelerate, ICH M11).

Clinical & Protocol Standards Support
" Support protocol and clinical document standards, including incorporation of external standards and guidance.
" Maintain and update clinical document templates, ensuring consistency with evolving regulatory and industry expectations.
" Support standardization and reuse initiatives across clinical documentation.

Process Mapping & Documentation
" Develop and maintain process documentation and process maps (high level and detailed) using approved tools (e.g., iGrafix, Visio).
" Maintain a catalog of medical writing processes, including linkages between SOPs, standards, templates, and training artifacts.
" Support continuous improvement initiatives through clear documentation of current state and future state processes.

Training & Enablement Support
" Support training development and preparation related to SOPs, standards, and templates.
" Develop supporting materials such as training slide decks, reference guides, and communication materials.
" Support identification of impacted stakeholders and coordination of training readiness activities.
Quality & Compliance Support
" Support quality control (QC) activities related to SOPs, standards, templates, and training materials.
" Support inspection readiness through accurate documentation, traceability, and controlled updates.
" Ensure alignment with GxP expectations, internal SOPs, and applicable regulatory guidance.

Other responsibilities and projects that the Company may assign.

Bachelors Degree

Competencies
General Experience & Knowledge:
Prior experience in medical writing, clinical documentation, or related pharmaceutical roles.
Experience supporting SOPs, standards, processes, or quality systems in a regulated environment
Technical Skills & Systems Knowledge:
" Veeva Vault (document and quality management systems)
" Process mapping tools (e.g., iGrafix, Visio)
" Microsoft 365 applications
" AI enabled productivity tools (e.g., Microsoft Copilot)

Behavioral Competencies
" Strong understanding of clinical documentation standards
" Ability to work independently and proactively
" Ability to work cross-functionally
" Strong organizational skills
" Strong written communication skills
" Ability to rapidly connect concepts across processes, standards, and documentation
" Results driven with strong attention to quality and detail
" Works independently

About the Company

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Integrated Resources, Inc

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