Medical Writing Operations Specialist

Contract position

JOB SUMMARY

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.

MAJOR 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.

Education Level

Bachelor's 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.