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Project Compliance Specialist / Project Manager

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Working with some independence and limited supervision, responsible for assisting the Compliance Manager in driving the standard setting, planning, coordination and processing of promotional materials to ensure timely approval of quality branded, unbranded, disease state and sales training materials in compliance with regulatory standards and company policies.

The Project Compliance Specialist assists in acting as a centralized knowledge hub for material approval and provides guidance to project owners/agencies/reviewer on the process to streamline material review

The Project Compliance Specialist will collaborates with Brand to set prioritization of review to manage review priorities against business needs, assist in triage of materials for appropriate review and provides guidance on submission readiness.

The Project Compliance Specialist also leads Material Approval Process (MAP) review meetings ensuring all review requirements and processes are followed, effective time management, and promotes collaborative problem-solving and teamwork.

Prepares pertinent approval documentation and ensures distribution of the materials submitted to reviewers for compliance review.
•Reviews materials submitted for review to ensure readiness according to established criteria and templates as applicable (e.g. proper referencing and annotations)

Tracks all submissions to ensure task completion and for monthly reporting purposes (metrics) to senior management.

Ensures effective implementation and use of any electronic review tools

Assists in identifying team/process/system issues and assists team to address collaboratively, recommending systemic process improvements.

Assist in training stakeholders on MAP Assists with special projects as needed (e.g. development of new SOPs).

Remain current on all compliance requirements and processes as they pertain to promotional practices and guidelines established by the corporation.

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