Associate Manager of Training and Development

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The Opportunity
Description
We're looking for an Associate Manager of Training and Development, working in Pharmaceuticals and Medical Products industry in 2525 Dupont Drive, Irvine, California, 92612, United States.

Job description:

• Collaborating globally with functional process owners within R&D to drive the development, revision, implementation and retirement of R&D processes.
• Driving the review and approval workflow and function as an administrator within the document development and management systems.
• Ensuring alignment with regulations and company policies and consistency across processes.
• Identifying process-related issues and support process improvements.
• Supporting the preparation and conduct of audits and health authority inspections.
• Regularly update industry and company specific knowledge and continuously improve skills related to the development, documentation and management of processes.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

Requirements:

• BA/BS with 6 years of experience in research and development (MS/MA in related field may substitute for 1 year of experience)
• At least 2 years at advanced management and operations levels
• At least 3 years directly related to management of systems and processes in a regulated environment

Knowledge:

• Excellent knowledge of GxP, ICH guidelines, PhRMA code, FDA CFR, ISO clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Proficient with electronic document management systems (EDMS) and business process mapping systems (e.g. Nimbus, TaskMap)
• Proficient with processes required for the creation of robust processes and procedures
• Knowledge of clinical study operations and the drug development process
• Knowledge of concepts of clinical research and drug development
• Proficient with electronic systems including, Visio, MicroSoft Office Suite, SharePoint, WebEx

Competencies:

• Ability to handle and prioritize multiple priorities
• Self-starter with ability to work independently at the regional or global level with remote or minimal supervision
• Ability to work effectively in a team/matrix environment
• Ability to influence others without direct reporting relationships
• Ability to understand technical, scientific and medical information
• Demonstrated strengths in customer service, planning, organizational, project management and analytical skills, oral and written communication, time management, negotiation, conflict management and resolution, attention to detail, interpersonal and networking skills, relationship building, cross-cultural sensitivity

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?

Location: East Irvine, CA, US

Posted Date: 11/22/2024