US - Medical Writing Operations

US - Medical Writing Operations#26-16113 Raleigh, NC Onsite Job Description Please note: in line with

• policy, this role is VDI only.
• will not be providing a laptop or equipment.

Part time - 20 hrs per week Must be online for meetings 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

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."