AddressHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Director Global Patient Safety Project Management US - Remote
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will serve 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
Raises issues / problems related to ongoing 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
We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.
Basic Qualifications:
Doctorate degree and 4 years of directly related experience
OR
Master’s degree and 8 years of directly related experience
OR
Bachelor’s degree and 10 years of directly related experience
Knowledge 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 comprehend pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
Ability to work in international environment and with cross-functional teams,
Ability to identify and anticipate risk of non-compliance in a complex environment
Knowledge of business area and regulatory environment and ability to identify and understand the interactions necessary for achieving business goals and objectives
Preferred Qualifications:
PMP certification
Successful completion 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
Experienced in group facilitation – ability to guide teams to make decisions and achieve deliverables within agreed parameters and timescales
Thrive
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.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your 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.
