Career Category

Regulatory

Job Description

Job Description:

The Regulatory Data & Systems Manager will be responsible for facilitating system administration tasks and interpreting requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves managing and optimizing complex systems, ensuring compliance with regulatory regulations and guidance, and facilitating effective communication between various departments involved in the submission process. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs, and project management.

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 8 years of directly related experience
• OR
• Associate’s degree and 8 years of directly related experience
• OR
• High school diploma / GED and 8 years of directly related experience

Preferred Education and Experience:

• Practical experience with regulatory data standards, such as IDMP
• 5+ years’ experience in administering large scale enterprise systems in the Biotech/Pharmaceutical industry

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