Senior Manager, Global Development Process and Procedures

As a Sr. Manager of Processes and Procedures you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Functioning as Process and Procedure Manager, leads/facilitates Process and Procedural Development Project Plans with the respective functional owner(s)/Subject Matter Experts, to support development/improvement of related process (New and Revised)
•  Coordinates the development, review, content/comment management and approval of PD with the Authors/ Writers. Assist in the writing of the PD and associated documents, as applicable
•  Initiates cross-functional Management review, as needed for agreement of major process changes, including Change Management activities.
•  Assures that PD's have the appropriate SME review, do not conflict with other procedures or overall GCP and other regulatory requirements
•  Assures that an appropriate transition, communication and implementation plan is developed in collaboration with the Project Management Office (PMO) and functional owner(s)
•  Lead, design, develop and facilitate face to face information/process sessions, performance support tools and learning programs (e.g., eLearning) to support the implementation of new/revised PD and associated documents
• Works with the Training function to ensure that training requirements are implemented and current within the REGN Learning Management System
•  Facilitates and assists in the development of Corrective and Preventative Plans as a result of
• Process audits and Inspections
•  Tracks and develops process effectiveness reports based on internal requirements
•  May require up to 25% travel

You are:

• Ability to think translate operational needs to process
• Proven ability to work effectively across multiple stakeholders
• Effective communicator (written and oral)
• Ability to work independently and influence across, up and down the organization
• Proven ability to manage multiple complex responsibilities and priorities
• Experience in working in or with Clinical Trial Management, Regulatory, Pharmacovigilance, Medical Affairs and/or Risk Management
• Strong analytical skills with ability to navigate through complex scenarios
• Experience in procedural document principles, process design, and leading process improvements is required
• Client Focused and attention to detail with demonstrated organizational and emotional intelligence/awareness
• Ability to plan, manage and optimize resources across a matrixed organization with multiple projects
• Strong knowledge of Clinical GCP and regulatory requirements
• PLEASE NOTE: this is a 6-month assignment with potential renew

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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