Sr Associate GRAAS Operations

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.