5 And Jobs

To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support Quality Assurance of ICSR medical review (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year of related drug safety experience Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including Safety Database and medical coding Knowledge of safety data capture in Clinical Trials and Post Marketing setting Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work

As a Senior Base STD Characterization Engineer, you will work in a highly innovative, motivated, young, and dynamic design team capable of verifying complete products using state of the art STD Cells , Custom Cells on latest CMOS process technology Responsibilities Silicon smart based STD cell characterization experience. Writing vector/ARC for STD Cells Responsibilities for hspce (hspice/spectre) based characterization. Circuit understanding Basic building blocks - AND , NAND , NOR , latches , flops design understanding Block level circuit simulation , Analysis capability STD cell timing checks - linearity , monotonicity , QA experience Analysis of Circuits , Timing concepts schematic analysis Collaborate closely with design and verification team members spread across the globe, many of whom have decades of experience in memory design. Opportunities to work closely with cross functional groups such as Product Engineering and Design Architecture. May also review vendor capability to support product development. 3-5 years of experience

As a Senior Base STD Characterization Engineer, you will work in a highly innovative, motivated, young, and dynamic design team capable of verifying complete products using state of the art STD Cells , Custom Cells on latest CMOS process technology Responsibilities Silicon smart based STD cell characterization experience. Writing vector/ARC for STD Cells Responsibilities for hspce (hspice/spectre) based characterization. Circuit understanding Basic building blocks - AND , NAND , NOR , latches , flops design understanding Block level circuit simulation , Analysis capability STD cell timing checks - linearity , monotonicity , QA experience Analysis of Circuits , Timing concepts schematic analysis Collaborate closely with design and verification team members spread across the globe, many of whom have decades of experience in memory design. Opportunities to work closely with cross functional groups such as Product Engineering and Design Architecture. May also review vendor capability to support product development. 3-5 years of experience

As a Senior Base STD Characterization Engineer, you will work in a highly innovative, motivated, young, and dynamic design team capable of verifying complete products using state of the art STD Cells , Custom Cells on latest CMOS process technology Responsibilities Silicon smart based STD cell characterization experience. Writing vector/ARC for STD Cells Responsibilities for hspce (hspice/spectre) based characterization. Circuit understanding Basic building blocks - AND , NAND , NOR , latches , flops design understanding Block level circuit simulation , Analysis capability STD cell timing checks - linearity , monotonicity , QA experience Analysis of Circuits , Timing concepts schematic analysis Collaborate closely with design and verification team members spread across the globe, many of whom have decades of experience in memory design. Opportunities to work closely with cross functional groups such as Product Engineering and Design Architecture. May also review vendor capability to support product development. 3-5 years of experience

ROLE OVERVIEW RESPONSIBILITY Finance, Accounting Budgeting (90% of time): Participate in month-end accounting close including: accruals, amortizations, reclasses, general ledger validation and month-end charge backs Analyze monthly-end PL variances to ensure validity of account and highlight trends Assist in quarterly balance sheet substantiation and country exposure reporting (SOX requirement) Participate in quarterly budgeting/reforecast process Assist with employee relocation compensation reporting Ad-hoc project work as needed Invoicing (10% of time): Facilitate invoice payments by coordinating with internal invoicing team, Accounts Payable, business leads and external vendors Validate invoices against firm policies and vendor contract terms Track invoice payments to ensure appropriate invoice accruals BASIC QUALIFICATIONS Bachelors or Masters of Commerce or CA Inter (IPC) 5+ years of work experience in relevant finance and accounting (ie expense side) PREFERRED QUALIFICATIONS: Advanced Microsoft Office skills, especially Excel (eg SUMIF, IF, AND, OR functions, pivot tables, workbook management) Strong understanding of finance and metrics management and reporting Highly developed analytical and process management skills Proven ability to succeed in and collaborate with fast paced and cross functional global teams (eg accounts payable, payroll, business leads, controllers) Strong communication skills