Process and Procedural Document Management Lead - UK (Remote) - FSP

Parexel is currently seeking a Process and Procedural Document Management Lead, to join us in the UK, dedicated to a single sponsor.

This role will be responsible for the management of the Clinical Medical Controlled document (CMCD) process and procedural document portal (relational database that includes business process modeling and allows for management of controlled documents and associated information with an end user interface which provides the business access to internal sponsor colleagues, auditors, vendors, and regulatory authority inspectors), structure, content, quality and core and end user implementation from a global and local country & functional area perspective.

This position’s responsibilities include overseeing and performing quality checks for all processes and associated content and documentation for consistency and standards and assisting process documentation designer with development, revision, maintenance

and oversight of specific activities, such as mapping process flows and associated content.

Working as a Process and Procedural Document Management Lead 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

Process Framework

• Accountable to manage and implement the quality oversight plan for the process portal content containing ~42,000 informational objects pertaining to process quality standards, global and local country & functional area procedural documentation (policies, SOPs and associated documents) and other related information to ensure ongoing availability of complete and accurate process and procedural document content for clinical, medical, safety, regulatory and enterprise quality management system processes. (It is essential that this content remains accurate and up to date as it is included in Pharmacovigilance regulatory submissions).

• Function as a key subject matter expert in the process framework, process architecture, process modeling or standards and conventions. Advise, coach and train CMCD authors, Document Specialists, Process Owners, and other process experts enabling accurate and efficient execution of business processes and use of business applications.

• Interpret business challenges and best practices to deliver strategic recommendations regarding process portal design and implementation; propose options to resolve complex problems and make decisions within business line.

• Lead/support development and ongoing evaluation of departmental processes, providing advice on process enhancements, continuous improvement and project management.

• Manage to resolution any questions about or issues arising from the Process portal, process modeling or standards and conventions.

• Serve as the subject matter expert and liaise with Information Management partners for user acceptance testing of new versions of the underlying portal management software or resolution of technical issues.

• Oversee support staff and contingent workers in daily activities related to the process portal, including training on process enhancements, and providing feedback and remediation.

• Enter and maintain data/information into the CMCD process and procedural document portal by collaborating with the CMCD authors.

• Independently manage the S&T query assistant website business process and content of over 1200 questions/answers.

• Lead special projects related to process portal as requested by supervisor.

Departmental Metrics

• Independently prepare monthly/biannual/annual metrics, identify and evaluate metric trends; lead the review, endorsement, issue follow-up/resolution, and communication of metrics.

Controlled Procedural Documentation Management

• Oversee the activities of procedural document compliance staff; maintain consistent workflow, prioritize needs, and establish coverage; provide coaching and guidance to staff members; review work of staff members as needed; and keep staff members up to date on internal processes, manages resolution to queries; manages projects pertinent to the role.

• Perform quality control checks for globally managed procedural documents, by following internal processes and established standards within agreed timelines, including prioritizing multiple tasks for timely completion.

• Support documentation life cycle within the Global Document Management System (GDMS) to maintain a state of inspection readiness.

Process Evaluation/Integration & Acquisition

• Facilitate/contribute to the evaluation of regulations, acquired procedures, etc. into sponsor processes ensuring proper compliance, documentation, and implementation plans.

Audit/Inspection Readiness & Support

• Facilitate/oversee the accuracy and completeness of process portal data by evaluating queries, performing data reviews, and reconciling findings to ensure accurate reporting.

• Contribute to compliance and inspection/audit readiness strategies and plans.

• Participate in regulatory inspections, and other internal audits by, interpreting the requests, checking quality control and providing information, and responding to findings.

Resource Management

• Monitor the daily operational work of 1-6 indirect reports (colleagues, including contingent workers as applicable).

Here are a few requirements specific to this advertised role.

Education:

• Degree is preferred, ideally a scientific or technical subject or a business degree and/or coursework with specific training in the following: process modeling, design, analysis and improvement methodologies and tools, data analytics, including data connections, query design, chart/visual development and tools.

Skills and experience:

• In general, candidates for this role would have the following levels of education/experience: BS and over 7 years; MS and over 5 years, or 10 years relevant experience in pharmaceutical industry.

• Experience in process design and modeling methods, demonstrated ability to design effective processes.

• Demonstrated experience in project management and implementation techniques.

• Previous continuous improvement experience considered a plus.

• A strong working knowledge and understanding of drug development processes, database structures, relational database management software, and data analysis tools.

• Strong interpersonal skills with a demonstrated ability to influence/interact with many levels of technical and business staff. Excellent analytical and organizational skills are required. The candidate must also possess very good communication skills (both written and verbal).

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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