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Director Global Patient Safety Project Management US- Remote

Company: Amgen
Location: Thousand Oaks
Posted on: January 9, 2022

Job Description:

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 ManagementLiveWhat you will doServing 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 ManagersSupport the Process Governance structure for GPSEnsure appropriate and consistent project management support is provided across GPSSupport departmental best practices in project managementIn a supervisory and direct capacity provide project management support to process improvement initiatives for all departments within GPSDirectly support Business Critical Projects as requiredWork cross-functionally to represent GPS in a Project Management capacityLiaise with other project management groups to ensure alignment of global safety plans with other functional plansProvide Project management support and oversight for M&A Safety activitiesIdentify and create communication and issue identification/ resolution plans as requiredMonitor and, as necessary, confirm data accuracy in safety systems for key deliverablesEscalates issues / problems related to on-going projects to senior management in a timely manner and as neededUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessBe the point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibilityFacilitate 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 requiredSupport PV Compliance Related activities as requiredResponsible for oversight of Global PV Regulatory IntelligencePerforms other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by direct supervisorManagement Responsibilities, as requiredEnsure staff are compliant with Amgen corporate and departmental trainingProvide training, coaching, mentoring, and development of staffSupport Project Managers as requiredParticipating in and overseeing talent management strategies such as annual reviews, performance management, succession planning and employee development and retention.WinWhat we expect of youKnowledge and SkillsBehavioral competencies and skills:Must have strong real-world Project Management skillsMust have experience in PV environment with additional demonstrable experience in project management.Must have change control experienceMust have strong leadership skillsMust 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 skillsWorks strategically to realize organizational goalsCritical thinking and decision-making skillsExercise independent judgmentUnderstanding business needs with global business perspective and professional attitudeDemonstrate integrityMotivate and empower othersWork productively in a high-pressure environment.Ability to identify proactively and anticipate risk of non-compliance in a complex environmentKnowledge of business area and regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectivesAble to manage both time and priority constraints and to manage multiple priorities simultaneouslyAttention to detail and computer literacyTake initiative and autonomous actionAble to lead teleconferences and meetingsBe able to manage conflict effectivelyBasic QualificationsDoctorate degree and 2 years of directly related experienceOrMasters degree and 6 years of directly related experienceOrBachelors degree and 8 years of directly related experiencePreferred Qualificiations:PMP certificationSuccessful execution of major projects in regulatory or safety environmentStrong leadership experienceIndustry and/or Regulatory/Safety experienceReal world project management experienceChange control experienceProven experience in group facilitation ability to guide teams to make decisions & achieve deliverables within agreed parameters & timescalesThriveWhat you can expect of usAs 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply now for a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comJoin 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.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.

Keywords: Amgen, Thousand Oaks , Director Global Patient Safety Project Management US- Remote, Executive , Thousand Oaks, California

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