Director Global Patient Safety Project Management US- Remote

HOW MIGHT YOU DEFY IMAGINATION?

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. Join us.

Director GPS Project Management

Live

What you will do

Serving as the primary lead within Global Patient Safety for the coordination of project management activities by developing and directing project management operations and strategic planning to meet organizational goals.

This position is responsible for providing strategic, leadership and technical expertise for the successful implementation of GPS Projects. The position will also provide overall strategic governance for projects by establishing standards, processes and tools required for effective project delivery. Additionally, the role is accountable for supporting project management to ensure GPS has a robust continuous improvement and change control system.

• Supervision of 0-6 Project Managers
• Support the Process Governance structure for GPS
• Ensure appropriate and consistent project management support is provided across GPS
• Support departmental best practices in project management
• In a supervisory and direct capacity provide project management support to process improvement initiatives for all departments within GPS
• Directly support Business Critical Projects as required
• Work cross-functionally to represent GPS in a Project Management capacity
• Liaise with other project management groups to ensure alignment of global safety plans with other functional plans
• Provide Project management support and oversight for M&A Safety activities
• Identify and create communication and issue identification/ resolution plans as required
• Monitor and, as necessary, confirm data accuracy in safety systems for key deliverables
• Escalates issues / problems related to on-going projects to senior management in a timely manner and as needed
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be the point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Facilitate Executive Safety Committee (ESC) and Global Safety Team (GST) meeting planning, slide preparation, meeting attendance, communication of outcomes to stakeholders, and follow-up on action items as required
• Support PV Compliance Related activities as required
• Responsible for oversight of Global PV Regulatory Intelligence
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by direct supervisor
• Management Responsibilities, as required
• Ensure staff are compliant with Amgen corporate and departmental training
• Provide training, coaching, mentoring, and development of staff
• Support Project Managers as required
• Participating in and overseeing talent management strategies such as annual reviews, performance management, succession planning and employee development and retention.

Win

What we expect of you

Knowledge and Skills

Behavioral competencies and skills:

• Must have strong real-world Project Management skills
• Must have experience in PV environment with additional demonstrable experience in project management.
• Must have change control experience
• Must have strong leadership skills
• Must be able to comprehend pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
• Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills
• Works strategically to realize organizational goals
• Critical thinking and decision-making skills
• Exercise independent judgment
• Understanding business needs with global business perspective and professional attitude
• Demonstrate integrity
• Motivate and empower others
• Work productively in a high-pressure environment.
• Ability to identify proactively and anticipate risk of non-compliance in a complex environment
• Knowledge of business area and regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
• Able to manage both time and priority constraints and to manage multiple priorities simultaneously
• Attention to detail and computer literacy
• Take initiative and autonomous action
• Able to lead teleconferences and meetings
• Be able to manage conflict effectively

Basic Qualifications

• Doctorate degree and 2 years of directly related experience

Or

• Masters degree and 6 years of directly related experience

Or

• Bachelors degree and 8 years of directly related experience

Preferred Qualificiations:

• PMP certification
• Successful execution of major projects in regulatory or safety environment
• Strong leadership experience
• Industry and/or Regulatory/Safety experience
• Real world project management experience
• Change control experience
• Proven experience in group facilitation ability to guide teams to make decisions & achieve deliverables within agreed parameters & timescales

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we 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.

careers.amgen.com

Join Us

If 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.

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.