Senior Associate - Regulatory Information Management & Systems ( RIMS)

What you will do

Let's do this. Let's change the world. In this vital role you will focus on driving key business operations initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory submissions.

As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and systems. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape. Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets.

• Operational Support

Provide ongoing operational support for regulatory data management, submissions, and EU Clinical Trials Regulation (EU CTR), ensuring timely and accurate submissions in compliance with global regulatory requirements.

• Process Improvements and Automation

Identify, develop, and implement process improvements and automation opportunities to streamline regulatory workflows and reduce manual efforts.

• Data Management and Analysis

Manage regulatory data efficiently, utilizing advanced data management tools and techniques to ensure data integrity, and provide insights for regulatory operations.

• Technical Proficiency

Leverage proficiency in office suite tools, Veeva Vault, SQL queries, and other data management programs to execute tasks effectively and support business operations.

• Technical Skills for Data Extraction

Use a solid understanding of technical and coding skills to pull and analyze data from various systems, enabling informed decision-making and improving regulatory performance.

• Data Presentation and Reporting

Organize and present complex data in user-friendly, graphical, and interactive summaries that provide insights into business performance and illustrate opportunities for process enhancements.

• Global Collaboration

Work closely with global teams to ensure consistent processes, adherence to regulatory requirements, and alignment across regions for all regulatory systems and initiatives.

• Continuous Improvement

Monitor regulatory processes and systems performance, utilizing data analysis to identify trends, risks, and areas for improvement, and ensure ongoing optimization of regulatory operations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Master's degree OR
• Bachelor's degree and 2 years of directly related experience OR
• Diploma degree and 6 years of directly related experience

Preferred Qualifications:

• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• In depth understanding of the Veeva Vault system
• Good written and verbal communication skills
• Detail oriented
• Independent time management and prioritization skills
• Work efficiently with little support and minimal to no supervision
• Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
• Critical thinking skills
• Appropriate software skills as required
• Strong analytical and problem solving, communication and presentation skills
• Good understanding of business complexity and project inter-dependencies
• Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus
• Fluent in English, both in oral and written communication
• Experience in supporting and leading projects / improvement initiatives

Good-to-Have Skills:

• Be open to work in a dynamic environment embracing change as a constant and adopting new technologies
• Work in global teams and matrix organizations
• Able to follow through on tasks and motivate others to meet deadlines

Soft Skills:

• Can do mentality / ownership to make it happen
• Pro-active / productive
• Positive mind-set and influence on the team
• Strong problem-solving skills
• Result driven
• Strong quality approach
• Accurate and very detailed approach
• Good communication and the ability to communicate appropriately at all levels of the organization; this includes written and verbal communications as well as visualizations