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Training and Compliance Specialist 2

Parexel International Corporation

United Kingdom - Any Region - Home Based

Any EMEA ocation: home based

Job Purpose

Deliver training and serve as a primary consultant for functional, systems or partnership training activities

to designated operational group(s). May serve as the Regional and/or Global Training Lead role for

assigned Courses, overseeing/coordinating course content, schedule and delivery. Also provide support for

audit and inspection activities and CAPA/quality issue support as assigned.

1. Deliver functional training, systems and/or client related training (depending on role and on assignments)

2. Serve as Regional/Global Training Leadership, providing consultancy on training related matters and align course content to changes/updates in system, process, organization and regulation.

3. Support development of functional, systems and/or client related training materials through regular stakeholder engagement as well as participation in initiatives and/or workshops to provide consultancy on

training impact for courses assigned

4. Provide audit and inspection support, as assigned. This may include:

providing assistance/advice for audit/inspection preparation; providing training-related or other input for audits and inspections as assigned; reviewing assigned audit/inspection responses.

5. Perform other assigned training, audit, inspection or quality issue-related tasks as well as Identify improvement opportunities related to training, audit/inspection and quality issue management.

6. Maintain a sound familiarity with and when assigned, serve as lead author and/or clinical subject matter expert of Parexel systems and related processes documentation.

7. Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Parexel SOPs, and where applicable, sponsor SOPs.

8. Participate in and/or champion the implementation of Parexel and department system/standards improvement activities.

9. Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling Parexel core

values. QualificationsSkills: Strong interpersonal, verbal and written communication skills Strong ability to deliver effective training Strong project management and leadership skills, ability to handle projects/tasks, potentially spanning different SBUs Strong ability to work independently with oversight, take initiative, and have a flexible approach with respect to work assignments and new learning. Strong client and quality focused approach to work Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization, able to remain calm in times of stress IT literate: experienced with Microsoft based applications, various clinical trial systems and general knowledge of personal computer functions Ability to travel as needed for the position Strong ability to think and work globally and be culturally aware Strong ability to effectively interface with clients

Knowledge and Experience Relevant pharmaceutical industry, CRO, Clinical or Medical experience with emphasis on GCP (ideal) and compliance. Experience in structured training delivery and/or development preferred. Education

Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience.

Apply now to begin your journey!

Job posted: 2021-09-14

3
Abonner