Document Control Specialist

Job Overview

The position will optimize and organize the flow and storage of clinical supply chain documentation and deliverables. In addition to administrative support, the Coordinator will collaborate with the Clinical Supply Chain (CSC) team to help drive process improvement initiatives within the department. This dynamic role offers significant opportunities for personal and professional growth, allowing for the utilization and development of additional skills. The employee must be able to leverage their existing skills and abilities to work effectively at the science-development-business interface. All activities and decisions are to be conducted in accordance with Company policies & SOPs, FDA & global regulatory guidelines (including cGMP/cGLP/cGCP), etc.

Responsibilities:

• Manages departmental email inbox and files documents in appropriate repositories (eTMF, eQMS, Share Drives such as Box or Sharepoint, etc).

• Independently identifies daily CSC issues that arise and determines resolution or appropriate team member escalation,

• Serves as a departmental resource for clinical supply team internal technologies.

• Coordinates and helps prepare meeting materials, including meeting agenda preparation/distribution, minute- or note-taking and assembling/editing PowerPoint presentations.

• Maintains high level of confidentiality and discretion when handling sensitive information during the execution of departmental objectives.

• Supports contract processing, invoice and purchase order tracking.

• Organizes and files documents for daily business needs.

• Propose continuous improvement opportunities to increase efficiencies within CSC

• Initiate approved interdepartmental projects and provide project management assistance when necessary.

• Support project transitions across teams

• May assist with on-boarding of new hires, either colleague or contractor staff.

• Maintain departmental document/knowledge repositories.

Qualifications:

• Minimum high school diploma or certification required. Associate or Bachelor’s degree a plus.

• Minimum of 3 years administrative experience.

• Knowledge of principles and practices of organization, planning, records management, and general administration.

• Ability to prioritize work assignments.

• Competency in Windows, MS Office (Word, Excel, PowerPoint), Adobe PDFs and other relevant computer software.

• Strong communication skills, verbal and written.

• Excellent organizational and time management skills.

• Exceptional attention to detail.

• Ability to work independently with limited guidance and direction.

• Good analytical and problem-solving skills.

• Ability to hit the ground running quickly.