Regulatory Data
1 day ago
Roles & Responsibilities:
- System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements.
- Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices.
- Project Coordination Assist in planning, tracking, and executing departmental projects and initiatives.
- Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates.
Required Knowledge and Skills:
- Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
- 5+ years experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies.
- Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
- Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
- Familiarity with GxP requirements and systems validation.
- Life Sciences, Biotech or pharmaceutical industry experience preferred.
- Proven Veeva Vault knowledge.
Preferred Knowledge and Skills:
- Advanced knowledge of Veeva Vault,
- Familiarity with global regulatory processes and standards.
- Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.
Basic Education and Experience:
- Bachelor's degree and 2 years of directly related experience
- Associate's degree and 6 years of directly related experience
- High school diploma / GED and 8 years of directly related experience
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