Job Number: 20899459
REGULATORY AFFAIRS PROJECT MANAGER
Role is 50% Onsite.
- Master's degree preferred.
- 8-10 years of relevant work experience required, preferably in a regulated pharmaceutical environment .
- Basic knowledge of GCP guidance and regulations .
- Knowledge and understanding of regulatory and technical training requirements and associated processes.
- Project management, problem-solving and decision-making skills .
- Strong analytical abilities; detailed oriented .
- Ability to present complex data in concise, executive level format .
- Advanced Microsoft suite of programs (Outlook, Word, Excel, and PowerPoint) .
- Experience with Learning Management System (LMS) and Document Management System (DMS) .
- Ability to work collaboratively with all employees at all levels .
- Ability to perform well in a team-based environment .
- The position is responsible for providing guidance, expertise and consulting to functional managers and SMEs in the assessment of training needs, the design of appropriate training and development delivery methods, the design of implementation plans, and the measurement of training effectiveness.
- Serve as a lead individual contributor within the GDO Training organization.
- Collaborate with functional area representatives, subject matter experts (SMEs) and cross-functional teams to Analyze, Design, Develop, Implement/Deliver, and evaluate key learning strategies and programs .
- Manage projects and training initiatives to effectively meet strategic business objectives in driving quality, compliance, and effectiveness .
- Evaluate training effectiveness and recommend changes in program content or methods, impact to audience, and presentation methods .
- Provide high level data analytics supporting business recommendations and strategic outcomes .
- Develop and maintain Quarterly and Monthly Dashboards for distribution to Senior Management .
- Supports the GCP Training department process and programs .
- Assists with new hire onboarding .
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-01991
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE