SOP & Training Specialist - Poland - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

At Parexel FSP, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

We are looking for a SOP & Training Specialist (Junior level) 100% home based in Poland.

On this role you will be responsible for ensuring high quality execution of controlled procedural documentation management used for the conduct of business in clinical, medical, regulatory, safety and quality assurance organizations in compliance with regulations, laws, company policy and best practices.

Your tasks will be

Controlled Procedural Documentation Management Responsibilities:

- Review of Local Procedural Documentation:

· Reviews global procedural documents to understand updates/changes

· Conducts central review of local procedural documents to determine if they are in compliance with the global procedure (impact analysis)

· Communicates with local procedural document authors to provide feedback on the central review outcome

Documents 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 prioritizing 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 the business 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.

Knowledge and Experience:  

· Demonstrated strong technical or digital skills in 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

Education: 

· Minimum of a Bachelor’s degree or equivalent.

Send me your updated resume to marta.kuniewicz@parexel.com for an immediate interview.