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Parexel is currently seeking a Quality SOP & Training Specialist to join us in the UK, dedicated to a single sponsor.
This role will be responsible for ensuring high quality execution of controlled procedural documentation management used for the conduct of the sponsor in clinical, medical, regulatory, safety and quality assurance organisations, in compliance with regulations, laws, company policy and best practices.
Working as a SOP & Training Specialist at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
Expect exciting professional challenges in inspiring studies, but with time for your outside life.
Responsibilities
Review Local Procedural Documentation:
- Reviews global procedural documents to understand updates/changes.
- Conducts central review of local procedural documents to determine if they are following the global procedure (impact analysis).
- Communicates with local procedural document authors to provide feedback on the central review outcome.
- Documents on the outcome of central review.
Periodic Procedural Document Assessment
- Coordinates automated notifications to authors of impacted local procedural documents that periodic assessments are due.
- Completes quality review of periodic assessments and communicates with local procedural document authors to provide feedback.
- Tracks the status assessment completion to ensure implementation and compliance.
- Issues escalation notifications to local authors who are non-compliant with periodic assessment requirements.
Quality Control Of Procedural Documents
- Performs quality control checks for global procedural documents, by following internal processes and established standards within agreed timelines, including prioritising multiple tasks for timely completion.
- Performs quality control checks of information in the process management relational database.
- Acts as a subject matter expert for established documentation standards and internal processes for consistency and compliance within a controlled regulatory environment, including providing accurate guidance and information to global procedural document authors.
- Supports documentation life cycle within the Global Document Management System (GDMS) and process management relational database to maintain a state of inspection readiness.
- Provides other documentation management support including, but not limited to GDMS searches, metrics, technology initiatives and process improvement projects.
Process Management Relational Database
- Adds data/information into the process management relational database (i.e., a database that includes business process modeling and allows for management of controlled documents and associated information with an end user interface which provides access to internal colleagues, auditors, vendors, and regulatory authority inspectors) by collaborating with the SOP authors.
- Completes data quality checks, periodic and ad-hoc reviews of the process management relational database content including follow-up on resolution of potential content discrepancies.
- Supports the following: running of departmental metrics and other reporting activities; provides advice on process enhancements and continuous improvement, support resolution any questions about or issues arising from the Process portal, partake in user acceptance testing of new versions of the underlying portal management software or resolution of technical issues.
Here are a few requirements specific to this advertised role.
- Minimum of a bachelor’s degree or equivalent.
- Demonstrated strong technical or digital skills in the use of digital systems and new software.
- Experience with design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical), or equivalent, such as experience of writing communications or training materials, intended for customers, or experience with process improvement projects and/or implementation of business process change management.
- Experience of completing quality control review of pharmaceutical business process documentation (safety, regulatory, medical and/or clinical), or equivalent, such as quality control
- review of other types of documentation, training materials, presentations, communications or reports.
- Experience of database maintenance, such as data entry, running reports and conducting data
- quality checks.
- History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
- Adaptable with the capability to manage multiple projects and adjust priorities as needed.
- Strong English communication skills (verbal, written and listening) with ability to use a variety of communication tools and techniques to explain difficult issues and work to establish consensus.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
Who Are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
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