Senior Manager - Global Labeling Compliance

Pharm Research Associates Limited ,
Reading, Berkshire
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Overview

At PRA we’re optimistic that, individually and collectively, we can help make tomorrow better than today. We believe that it is our obligation as a company to help our people find meaningful ways to respond to the needs of others around the world. This sense of common purpose pervades our culture and serves as the foundation of who we are. Explore our career opportunities today and find out how you can be part of it. Position overview: The PRA Labeling Compliance team is responsible for Global Labeling processes including the preparation of regulatory and compliance tracking reports, metrics tracking and preparation, maintenance of the QMS system, audit/inspection support, and IT systems supporting GL activities. As a Senior Manager in Global Labeling Compliance, you will be responsible for leading and guiding your team of direct reports, serving as an expert within Labeling Compliance to your team, internal and external stakeholders. Key responsibilities will include: · Maintaining an effective global team by recruiting, selecting, training, and coaching employees and providing employees with professional development and growth opportunities. · Setting clear objectives and communicating expectations, planning, monitoring and assessing individual and team performance · Tracking CCDS implementation based on data provided by Labeling systems, Global Labeling Leads (GLL) and Global Affiliates, escalating any non-response/possible non-compliance, providing summary reports to GL management as requested, and supporting the preparation of the Pharmacovigilance System Master File (PSMF) report and supporting documents. · Providing IT Systems support for GL activities in Mosaic, PRISM, and others, as needed. · Tracking compliance with GL processes, providing compliance data, labeling management and supporting GL activities. · Preparing GL summary reports, including escalations regarding the implementation of CCDS information into product labeling to ensure compliance to regulations and client processes. · Contributing to the development and update of QMS, developing and delivering training as required · Supporting the writing and tracking of CAPAs, tracking and compiling GL metrics You are: An experienced team manager with an eye for detail. Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have: · An extensive track-record of success working in labelling compliance · A strong background in people management · The ability to manage projects, assess and integrate information, identify and clearly communicate potential issues, and propose solutions · Adaptability, with a problem-solving and solutions-focused mindset · A relevant educational background to degree level. Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better. PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace. This job was originally posted as www.totaljobs.com/job/89628890

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