Regulatory Data & Systems Manager

nterpret 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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