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28 May 2019

Full-Time Manager, Process and Training (Clinical Trials)

Mallinckrodt Pharmaceuticals – Posted by egeurtse Anywhere

Job Description

The Manager, Process and Training, supports the process design and improvement services for the Science & Technology (S&T) organization. This includes collaborating with key stakeholders and functional and operation leaders to create, update, and implement Global Development Operations Quality Documents (QD), processes, and training while ensuring business objectives, quality standards and regulatory requirements are met. This position identifies and implements general GxP training opportunities and supports training initiatives across the S&T business. The incumbent also participates in S&T technology initiatives and supports the development and maintenance of dashboards metrics related to clinical operations efficiency and effectiveness.

Principal Responsibilities
1. Leads working group to create and/or enhance business process by mapping and documenting the current state, optimizing the process and implementing change.
2. Collaborates with process champion/owner in developing and implementing QDs and working tools (e.g., templates, forms, job aids).
3. Ensures QDs and processes are scientifically sound, regulatory compliant, cost-effective and time-efficient.
4. Maintains document management plan.
5. Oversees the administration and life cycle management of QDs and QD deviations.
6. Be a process improvement subject matter expert and advisor within the practice, among peers and with key business stakeholders including management.
7. Collaborates with process owner, functional and operational management in QD training, general role-associated training, and audit corrective actions.
8. Assist in delivering training that support functional areas within S&T (e.g., ICH, FDA Guidance documents).
9. Partners with process owner for implementation of technology and associated process changes and training.
10. Manages role-specific, project specific, and product specific training curricula, with feedback from Functional Managers.
11. Develops dashboards and other measurement tools that reflect the level of operational efficiency and effectiveness and also QD training compliance. Generates reports on all S&T functions and suggests improvements within the S&T business unit and Mallinckrodt that impact business process, function and burden.
12. Supports internal audits and regulatory inspections.

Minimum Requirements

Experience / Skills:

Education required/ preferred:
BS or BA degree. Advanced degree preferred.

Minimum of 5 years’ experience in healthcare Industry with a minimum of 2 years in process development.
Combined experience in Clinical Operations, QD development, training, and curriculum management.
Led business process design or improvement projects
Working experience with Document Management Systems (i.e., Master Control) and Learning Management System (ComplianceWire) preferred
Possesses a solid understanding of laws and regulations governing clinical trials, GCP, ICH and clinical development activities.
Understanding and experience within a global regulatory environment.

Works under minimal supervision; requires a high level of independence
Self-motivated with comfort working on high performing teams.
Ability to manage competing priorities demonstrating adaptability in meeting prioritized deadlines
Excellent written and verbal skills including facilitation and presentations.
Effective interpersonal skills and collaboration
Ability to lead others by influencing (i.e., without direct line management)
Proficient with the Microsoft Office suite (i.e., Word, Visio, Excel, PowerPoint, etc.) and Adobe.

How to Apply

If interested and qualified, please apply by visiting the link below:

Job Categories: Equal Opportunities. Job Types: Full-Time.

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