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