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PRA Health Sciences
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Swansea, West Glamorgan
Associate - Regulatory Operations
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Job Type: Full-time |
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Overview
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and the possibility to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Position overview: Our Regulatory Operations team draws from years of industry experience to support our clients (pharmaceutical companies) in the management of their licences for their products, including project managing the submissions required to market these innovative treatments. As an Associate, you will work with different members within this team, supporting your colleagues with various tasks to ensure successfully delivery to our clients and adherence to industry-specific regulations. Key responsibilities will include: Providing document management support, including compilation of electronic documents to ensure submission-readiness Assisting in ensuring submissions are published according to PRA’s standard operating procedures, including the review of documents to ensure they fulfil client and regulatory agency specifications Supporting report- or document-level publishing Performing quality control of documents and hyperlinks Various data entry tasks, including entering key data into PRA’s RIM systems Performing data verification activities on behalf of data owners Assisting with data quality and data remediation activities Establishing and maintaining effective direct communication with information providers, verifiers, and key stakeholders Completing the linking of data to relevant regulatory documentation/systems. Tracking data issues and escalating as appropriate As your experience grows, so too will your career. In the future, you may choose to specialise within a specific area of Regulatory Operations, for example Publishing or Regulatory Information Management (RIM). You are: Adaptable, a strong communicator and a team player. 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: Strong technical / IT skills, including proficiency in Microsoft Office The ability to learn new skills from other team members and be adaptable to changing business needs Solid written and verbal communication skills to ensure you can collaborate with colleagues from around the world The ability to multi-task and balance priorities A relevant degree-level qualification, ideally within the field of life-sciences or a technical or business-related area. We are also open to candidates without a degree but who bring with them previous relevant professional experience in a corporate environment 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.