Analyst 2 - Quality Systems Document

Overview: This role will assist in managing the procedural documents lifecycle (i.e., policies, standard operating procedures, work instructions, manual, guidelines, and forms) for the Scientific Affairs (SA), US Medical Affairs (MA) and Regional Commercial Quality North America organization in the Electronic Document Management System (EDMS), truVault (Veeva Quality Docs). The role will assist in the following tasks:

coordination and tracking of periodic reviews

revision and obsolescence of documents

impact assessment process management

contribution of training contents and audience identification for procedural documents

updates to the US CQ Quality Manual and related reference documents



This position is also responsible for ensuring that SA/MA procedural documents are consistent and aligned with Pharmaceutical global processes, including but not limited to Pharmaceutical Enterprise Quality Standards, Cross Sector Documents, Commercial Quality Documents, Pharmaceutical Guidance Documents, HCC, Cross-Pharma, and Global Medical Organization documents.

This is intended to be a general job description and should not be construed as all inclusive.



ESSENTIAL FUNCTIONS: Define key accountabilities and/or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. % OF TIME

Procedural Document Management

Manage the review & approval cycle to ensure procedural documents meet established development timelines and facilitates periodic review per procedural lifecycle requirements.

Liaise with other Pharmaceutical organizations when SA/MA or NA CQ procedural documents have interdependencies with those groups.

Ensures alignment of Pharmaceutical standards, policies and procedures across SA/MA and NA Regional procedural documents.

Manages procedural documents in electronic document management system

Reviews findings, and monitors compliance trends related to procedural documents and communicates compliance issues/concerns to department manager.

Assists during the impact assessment review and documentation process 75%

Training/Compliance

Assists in identification of procedural document training audience with functional area managers

Collaborates with Process Owners, Subject Matter Experts, and Training Managers in the development and review of training content/materials.

Develop procedural document metrics and monitor compliance. 25%