Senior Manager



October 7, 2022

Job Description


If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Manager Regulatory Data Analytics and Reporting (open to remote)

What you will do

Lets do this. Lets change the world. In this vital role you will provide strategic leadership for Regulatory Affairs Analytics, Data Standards (XEVMPD/IDMP) and emerging Data Standard compliance requirements.

Responsibilities include:

  • Ensure compliance with international data standards to ensure compliance with Health Authority regulations for submission and registration.

  • Collaborate cross-functionally internally and externally with Global Regulatory Affairs and Strategy (GRAAS) to identify Regulatory Data and Analytics requirements.

  • Lead Strategy development and implementation for new and existing Regulatory Data Standards, Analytics, and Reporting.

  • Partner with Digital Technology and Innovation (DTI) Team to develop multi- year Data Standards, Management, and Analytics to increase Regulatory Data Visibility and insights.

  • Increase data visibility to make it easier for staff to quickly and confidently find the right data for their business decisions.

  • Minimize potential errors by establishing policies & processes for data usage.

  • Set standards to scale data and usage with repeatable processes to keep (meta) data up to date.

  • Leverage global regulation data to support system and process simplification, automation and innovation.

  • Organize and present data in user friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance.

  • Own the implementation of EU Clinical Trial Submissions for GRAAS.

Key Skills and Knowledge

  • Sharp learning agility and analytical thinking

  • Veeva Vault Knowledge

  • Organizational Change Management to adopt new processes and practice

  • Team Leadership, Coaching, and Mentoring.

  • Customer-Centric

  • Vendor Management

  • Communication and relationship building.

  • Hands-on ability to work on data analysis and reporting

  • Strong Knowledge of managing structured and unstructured data

  • Demonstrated excellence in project and change management and stakeholder engagement

  • Excellent understanding of Regulatory Affairs business complexity and project interdependencies

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of related experience, OR Masters degree and 4 years of related experience OR Bachelors degree and 6 years of related experience

Preferred Qualifications:

  • Five years of experience directly managing people and successfully leading global teams, programs, and projects.

  • Strong understanding of Regulatory Operations processes and systems, including Regulatory Information Management and data management.

  • Ability to build compelling business cases with accurate cost and effort estimations

  • Experience developing and handling a budget.

  • Lean/Six Sigma or other process improvement methodologies.

  • Certification in Veeva Vault.

  • Proficiency in data visualization tools or packages, such as Tableau or Spotfire.

  • Intellectual curiosity and the ability to question partners across functional areas.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization

  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Join UsIf you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.

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.