Location: RTP, NC / Cambridge, MA

Job Type: Contract

Duration: 18 months



C2C AND REMOTE OPTION NOT AVAILABLE



This position will be responsible for modeling in myBPM/ARIS (Enterprise Business Process Modeling Tool) to establish a new electronic capability designed to organize and track Client’s product development compliance and regulatory submission requirements called the Product History File (PHF). The Product History File Process Analyst will also support management of the PHF business process framework within the ARIS software system to ensure a consistent, scaleable and repeatable approach to methodology, modeling and training.

Modeling in MyBPM/ARIS to create and optimize Product History File (PHF) models including stage gates, stage gate exit criteria, data objects, source document links, regulatory submission content as well as other designated attributes.



o Assure models are built in a consistent, scalable and reproduceable manner and aligned with ARIS standards and methodologies.

o Assists with determining where source documentation links should be located in the PHF

o Incorporate links from Client’s GxP systems into the appropriate location of the PHF, predominantly from the Content Management System.



• Work effectively with Asset Team, Quality Subteam, myBPM and PHF teams to plan, implement and coordinate PHF model deliverables.

• Provide project management support to assure appropriate prioritization and tracking of PHF and related Product Quality Development activities through effective coordination and communication to assure timely project completion.



Create and maintain PHF dashboard models in My/BPM/ARIS to communicate the status of key product development and compliance deliverables

o Assist in development of business cases to identify what types of dashboards are needed

o Assist in determining what PHF model optimization is required to maximize dashboard effectiveness

Support the design, implementation and enhancement of the PHF within PO&T

o Works with teams to identify areas for PHF improvement

o Assist leaders with monitoring and reporting progress on PHF process implementation

o Assist leaders in establishing PHF standards, guidelines and procedures