Global Clinical Process Management Senior Specialist

General Description:

The role provides coordination and operational support to Process Leads and senior GCPM leadership to enable effective execution of process management activities, document control workflows, governance alignment, status oversight, and intake-driven insights. The incumbent supports the preparation, organization, analysis, and tracking of key inputs, project plans, stakeholder materials, approval activities, reporting outputs, and GCPM intake data to facilitate timely decision-making, process progression, continuous improvement, innovation consideration, and consistent delivery of GCPM-owned initiatives.

Responsibilities:

Coordination Support to Process Leads

• Support document review and approval workflows to enable timely progression, system/document governance, and completion of required approval steps.

• Coordinate document control activities, including initiating Document Control engagement, supporting QA alignment, submitting and facilitating DCC activities, and tracking approvals through completion.

• Support information gathering, preparation, tabulation, and organization of inputs to enable efficient Process Lead review and decision-making.

• Assist with the development, documentation, and maintenance of project plans, including regular status reviews, updates, and follow-up on outstanding information.

• Support the creation and maintenance of stakeholder lists, meeting planning materials, and project charter drafts.

• Provide administrative support for organizational change management activities, including preparing draft communications under Business Owner and Process Owner guidance.

Coordination Support to Senior Manager

• Compile data from Veeva Vault or equivalent source systems to support status reporting and periodic review of processes under GCPM leadership.

• Prepare and maintain QE CAPA tables and related tracking materials for periodic review by the Senior Manager and Head of GCPM.

• Prepare and analyze data from the GCPM intake form to support management review, process improvement planning, and evaluation of potential innovation opportunities.

Supervisory Responsibilities:

• N/A

Computer Skills:

• Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project)

Other Qualifications:

• Fluent English (Oral; Written)

• undefined

• Knowledge of ICH-GCP

• Excellent interpersonal and problem-solving skills

• Excellent organizational skills and a pre-disposition to quality management and process improvement

• Effective communicator (oral and written)

Travel:

• N/A

Education/ Experience Required:

• Bachelor’s degree required. 2+ years of experience in pharmaceutical and/or biotechnology sector preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.