Think What’s Possible!

Ideas have the power to improve lives. And as a broad and diversified healthcare company with many colleagues dedicated to improving health and well-being around the world, our ideas have more power than most.

At Novartis, you’ll have the opportunity to work alongside an extraordinarily talented and diverse group of people from around the globe, all committed to making a difference for our diverse patients and customers.

You will benefit from our unique combination of great people, industry-leading products, innovation, and a high-performance, achievement-oriented culture, where you’ll find countless opportunities to progress professionally and personally.

Our results-driven rewards system will recognize you and your team’s achievements, and will encourage and value your continued professional development.

The position:
Job Purpose:

• Manages overall training activities in the Clinical and Regulatory Affairs Department and actively assesses training effectiveness to ensure we have a well trained and knowledgeable team conducting and supporting quality research in Canada.
• Build various capabilities to ensure we have the most effective team to reach our quality, productivity and innovation goals in Clinical Development in Canada.

Major Accountabilities:

• Identify training needs of Clinical and Regulatory Affairs associates and work with the functional heads and the Manager, Development Quality Assurance to develop and provide comprehensive training programs.
• In collaboration with Manager, Development Quality Assurance :

1. Work cross-functionally with HR & Sales Training to optimize the use of resources, tools, material and coordination of training activities for the benefit of the Clinical and Regulatory Affairs associates.
2. Work with the Global training groups to contribute to global training initiatives & subse-quently implement these locally.
3. Plan, organize and develop training material & tools, as well as evaluation systems for the impact of the various training programs

• Responsible for effective staff orientation and integration process for new Clinical and Reg-ulatory Affairs associates.
• Responsible for delivering training, as required, to Clinical Research personnel, on Global Development SOPs and local Working Procedures (WPs); as well as ensuring proper training is provided on various Clinical Development systems (eg. CREDI, Clin Admin, EDC…)
• Responsible to evaluate training effectiveness by conducting field assessments of CRAs.
• Contribute to building our various clinical research capabilities to ensure best-in-class and fully compliant organization, namely with respect to management of Clinical Research con-tracts. Minimum requirements Education :
• B.Sc. (minimum)

Years of experience:

• 5-7 years experience, occupying various role in Clinical Development (ideally, experience in monitoring & managing clinical trials).
• Previous training experience is an asset.

Language:

• Fully bilingual

Other:

• Strong knowledge & understanding of ICH-GCP, local Canadian Regulations & business codes (eg. Rx&D code)
• Thorough understanding of the overall clinical development process (from bench to bedside) in order to work at all levels of the Medical department
• Excellent communication skills (including very strong presentation skills & presence)
• Excellent interpersonal & coaching skills
• Ability to work effectively & influence cross-functionally
• Strong organizational & computer skills
• Willingness to travel

Novartis - 11 months ago