customs and trade compliance analyst

Abbott

<div>Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Working at Abbott 
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You&rsquo;ll also have access to:<div><div><div><div><ul><li>
Career development with an international company where you can grow the career you dream of.</li><li>
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.</li><li>
An excellent retirement savings plan with a high employer contribution.</li><li>
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor&rsquo;s degree.</li><li>
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.</li><li>
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.</li></ul>
The Opportunity
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
Our team is looking for a Customs and Trade Compliance Analyst to be based out of our office in North Chicago, IL.
This new team member will provide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws including, 19CFR, 15CFR, FDA, USDA, other PGAs and data metrics.
Responsibilities
<ul><li>Applies working knowledge of import/export regulations and requirements to support business needs.</li><li>
Consolidate and analyze import/export data to identify risks or opportunities for savings.</li><li>
Provide analytical support related to CBP Requests for Information, Post-Entry Amendments and Prior Disclosures.</li><li>
Ensure timely and accurate response to Broker Requests for Information and follow-up to ensure resolution.</li><li>
Ensure proper classification, valuation, and origin determination for the site&rsquo;s imported goods, including non-commercial goods.</li><li>
Interface with related functional areas (logistics, purchasing, materials management, finance etc.) on customs matters and coordinate training for personnel in these areas, as needed.</li><li>
Provide analytical support, as needed, for reporting price adjustments, royalties, etc. via the CBP Reconciliation Prototype Program.</li><li>
Conduct effective and timely transactional review/audit of all import/export records. This includes auditing import entry documents for data accuracy, value, and receipt.</li><li>
Elevate issues requiring correction to manager.</li><li>
Provide analytical support to general import/export-related projects, as needed. Including the ability to track and measure metrics on data elements such as clearance times, delivery times, volume of shipments, and other import related topics.</li><li>
Train and educate on latest Customs, FDA, USDA and other participating government agency import regulations.</li><li>
Accountable for compliant importation and exportation of goods and services, including proper classification and valuation. Failure to comply is a violation of law and could result in significant fines or penalties.</li><li>
Provide support to all customs and trade responsibilities for US import, US exports and other global trade needs.</li></ul>
Education and Experience
Required
<ul><li>Bachelor&rsquo;s degree preferred or an equivalent combination of education and experience.</li><li>
Minimum 2-3 years&rsquo; experience in import/export operations, international business, or other related field.</li><li>
Sound analytical abilities and acute attention to detail required.</li><li>
Effective communication (written and oral) and interpersonal skills are absolutely critical for this position.</li><li>
Ability to balance multiple priorities simultaneously and manage time appropriately.</li></ul>
Preferred
<ul><li>Bachelor&rsquo;s degree in Business, logistics/transportation, or another related field</li><li>
Proficient in Microsoft Excel, and power BI.</li><li>
Detail oriented with strong analytic skills.</li><li>
Experience with USHTS tariff analysis, origin and value determination.</li><li>
Familiar with manufacturing processes and medical equipment.</li></ul>
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.</div></div></div></div> 
The base pay for this position is $60,000.00 &ndash; $120,000.00. In specific locations, the pay range may vary from the range posted.</div>

Customs and Trade Compliance Analyst

Recruitinflux Private Solution

Contract Coordinator II (Hybrid &ndash; North Chicago, IL)Location: Lake County, IL (Hybrid &ndash; Onsite Tue&ndash;Thu) Duration: 12-Month Contract (Possible Extension)OverviewWe&rsquo;re seeking a Contract Coordinator II to support contract creation, negotiation, and management for consulting and promotional engagements. The ideal candidate is detail-oriented, organized, and skilled in ensuring accuracy, compliance, and timely contract execution.Key Responsibilities<ul><li>Prepare, review, and negotiate consulting and promotional speaker contracts.</li><li>Ensure compliance with internal policies and external regulations.</li><li>Collaborate with Legal, Compliance, and business teams to finalize agreements.</li><li>Maintain documentation and manage multiple contracts simultaneously.</li><li>Support process improvements and maintain accurate contract records.</li><li>Utilize SAP or other contract management tools to track and process contracts.</li></ul>Qualifications<ul><li>Bachelor&rsquo;s degree preferred.</li><li>3&ndash;5 years of experience managing contracts or similar documentation.</li><li>Strong communication, organization, and negotiation skills.</li><li>Ability to interpret guidelines and ensure compliance.</li><li>Proficient in Microsoft Office Suite; experience with SAP or contract management systems a plus.</li></ul>Schedule<ul><li>Hybrid: Onsite in North Chicago, IL Tuesday, Wednesday, Thursday (remote Monday &amp; Friday).</li></ul>Contract<ul><li>12-Month Term with potential for extension based on performance and business needs.</li></ul>Job Type: ContractPay: $27.49 - $35.11 per hourWork Location: In person

Contract Coordinator

AbbVie

<div>Company Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. 
Job Description 
Purpose
The function of Audit and Compliance Auditor is to performs comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.
Responsibilities 
<ul><li>
75% Travel</li><li>
Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications.</li><li>
Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates recommendations for corrective actions.</li><li>
Participates in strategic initiatives to improve compliance to regulatory requirements and standards.</li><li>
Collaborates with R&amp;D QA to coordinate and conduct joint audits.</li><li>
Communicates and coordinates supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites and commercial affiliates as well as external stakeholders</li><li>
Ensures audits are conducted according to the annual audit schedule.</li><li>
Ensures no product launch delays or business interruptions due to supplier audit delays thereby assuring supply to AbbVie patients.</li></ul> 

Qualifications 
Qualifications 
<ul><li>
Bachelor&rsquo;s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries. ASQ certification desired.</li><li>
6+ years of total relevant experience, including 4+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device, biotechnology or related industry and 2+ years in compliance/auditing is required.</li><li>
Must have a technical background, including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.</li><li>
Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support, and service and understand the principles of quality management</li><li>
Excellent oral/written communications skills. Must exhibit strong interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills, and sound judgment.</li><li><ul><li>Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas</li></ul></li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li><li>This job is eligible to participate in our long-term incentive programs
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Auditor, Audit and Compliance

<div>Company Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. 
Job Description 
Purpose:
Manage a team of Manufacturing Professionals assigned to Third Party Manufacture (TPM) contracts for small molecule products. Assure that high quality product is manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned.
Responsibilities:<ul><li>Lead a team of AbbVie TPM Account Managers to negotiate Manufacturing Service Agreement and amendments, and assure compliance with the terms of the agreements and Assure effective planning and material procurement strategies are in place to efficiently supply TPMs with required materials.</li><li>Assure global logistics are in place to support all phases of the manufacturing agreement in accordance with Purchasing and Supplier quality expectations.</li><li>Ensure timely communication to the TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules.</li><li>Lead the development of Financial Operating Plan, Updates, LRP, and Standard processes, and assure the financial goals are met.</li><li>Monitor manufacturing performance; apply performance metrics as appropriate and ensure work processes and standards align to deliver product in accordance with AbbVie quality expectations.</li><li>Assure in coordination with internal AbbVie functional partners that the TPM has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments. Coordinate with QA, the annual quality management review and periodic audits of the TPM. Assure deviations are properly investigated and product disposition decisions are made in a timely manner.</li><li>Lead a performance improvement culture &amp;amp; programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness.</li><li>Coach managers in the organization and establish clear expectations with them and all employees regarding responsibilities, goals and behaviours and champion and model exceptional AbbVie performance and talent management practices.</li><li>Coordinate routine management reviews and provide on-going communication informing internal and TPM stakeholders of TPM performance against expectations, highlighting issues, actions, and on-going improvements to increase performance at TPMs.</li><li>Represent Manufacturing as required with internal Brand Teams related to all aspects of the manufacturing process with TPMs and develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.</li></ul>
. 
Qualifications<ul><li> 
Bachelor&rsquo;s Degree required in a technical field: advanced technical degree (Master&rsquo;s or Doctorate Degree) strongly preferred.</li><li>15+ years&rsquo; experience including: work as an individual contributor building technical expertise and proven project management skills.</li><li>Progressively increased responsibility and performance as supervisor, department manager and leader of diverse teams in Operations (Manufacturing, Quality, Supply Chain, Engineering, etc.)</li><li>Business acumen coupled with functional leadership experience is required to ensure effectiveness and high performance in a complex operation.</li></ul>
. 
Additional Information<div></div> 
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Director, External Manufacturing - Small Molecule

TYG Consultant's

Location: Onsite / Hybrid ScheduleShould be in office (Tue, wed and Thu) (Shift timings 8 AM - 5 PM)Mon and Fri will be Work from HomeContract: 1 year - based on performance and business needsLength of Contract: One year with possible extensionsLocation/Site: Lake CountyRemote, 100% Onsite, or Hybrid Onsite Schedule: Hybrid Onsite Schedule<ul><li>Not looking for some one with T codes exp in SAP</li><li>Knowledge and understanding of contracts will be fine</li><li>not looking for contracts exp</li><li>Enter contracts in to the system</li><li>Candidate will be working on 10-15 cases in a day</li><li>Must have pharma background</li><li>Reconciliation work</li><li>When study is closed this team does reconciliation to close studies</li><li>When contracting teams creates their contracts this team will create the PO</li><li>Manage the clinical payments process</li><li>High possibilities of extension</li><li>Team of 15 people</li><li>Masters degree will work</li><li>Manage invoice issues for both vendor and sites</li><li>Resolving PO issues</li><li>Manage issues that may arise in paying invoice</li><li>Clinical background needed</li><li>Some understanding on clinical trials</li><li>Should be able to respond to e mails with in 2-3 business days</li><li>QC review of the contracts</li><li>Will not be writing contracts should know how to read contracts and should be familiar with contracts</li><li>SAP is a must have (knowledge)</li><li>Not looking for an accountant as this job does not involve journal entries</li></ul>Top Skills<ul><li>Invoice</li><li>Reconciliation</li><li>Knowledge and understanding of contracts</li><li>SAP</li><li>Purchase Order</li><li>Procurement exp</li></ul>What are the top 3-5 skills, experience or education required for this position:<ul><li>Bachelor&rsquo;s Degree with a minimum of 1 year of relevant experience or High School diploma or equivalent with minimum of 5 years relevant experience.</li><li>Must be able to use critical thinking skills to work independently under minimal direction to evaluate, manage, &amp; prioritize responsibilities. Strong understanding of the overall Global Clinical Study process is preferred.</li><li>Must be proficient in computer skills including MS Office with ability to learn new software/technology quickly. Strong knowledge of standard business procedures including contracting, finance, and budgeting.</li><li>Can operate in a very fast paced and changing environment, with the ability to pivot from task to task in a calm, effective and efficient manner</li><li>Ability to effectively communicate (verbally and written) with internal and external stakeholders</li></ul>Years Experience: 5+ yrs.<ul><li>Fresh graduate also considered</li><li>Lake County candidates Preferred</li></ul>Skills:<ul><li>Strong computer (excel) skills to work with complex databases</li></ul>Education:<ul><li>BA Degree</li></ul>Duties:<ul><li>Responsible for maintaining essential contract documents/data in the contract database to be in compliance with Corp. Purchasing, Finance, &amp; OEC Compliance policies.</li><li>Must be able to use critical thinking skills to work independently under minimal direction from management to evaluate, manage, &amp; prioritize contract processing tasks from pre-negotiated contracts through completion.</li><li>Work with Clinical teams, Clinical Analysts, appropriate departmental team members &amp; resources, and functional areas to maintain the flow of Purchase Order Payment Requests using the designated invoice screening/tracker database, and systems.</li><li>Maintain payments and historical entry in database to allow for accurate reporting.</li><li>Interpretation of clinical contracts and payment terms is required.</li></ul>Core Job Responsibilities:<ul><li>Responsible for compliance with applicable Corporate &amp; Divisional Policies &amp; procedures. Demonstrates operational knowledge of the applicable SOPs &amp; practices required to effectively process clinical contracts.</li><li>Responsible for the audit and financial reconciliation of clinical study trial vendor contracts utilizing various financial systems to summarize and consolidate payment history.</li><li>Performs ongoing contract entry for all executed contracts.</li><li>Primary interface with Clinical teams and other functional groups for payment-related activities. Assisting in the identification of payment discrepancies and propose resolutions and strategies to avoid them in the future.</li><li>Coordinate payment timelines between Payment Specialists and other functional areas.</li><li>Uses available databases and resources related to EDC database(s) in order to set-up payments in departmental database / system; May enter contract data into departmental database / system.</li><li>Communicate status to management including proposing recommendations for issue resolution.</li><li>Responsible for producing accurate and high-quality payments and reports in a timely manner.</li><li>Investigate and resolve issues that arise independently or with minimal oversight.</li><li>Coordinates clinical trial payments ensuring payments are properly processed within specified timelines including timely distribution of incoming invoices and tracking into appropriate databases.</li><li>Provides guidance/information &amp; answers to technical &amp; non-technical questions regarding contracting process.</li></ul>Position Scope:<ul><li>Requisition processing of vendor agreements and Clinical Study Agreements (CSA) into contracting database, including a solid understanding of any auditable documentation needed for payment processing. Recognize &amp; resolve vendor management issues to maintain system integrity (e.g., wrong supplier chosen by requisitioner).</li><li>Processing of monthly electronic data capture (EDC) invoices for CSAs operating in trials.</li><li>Verification of patient activity performed for each agreement when processing invoices.</li><li>Independently investigate and resolve clinical trial vendor or site payment disputes.</li></ul>Qualifications:List required and preferred qualifications (up to 10). Include education, skills, and experience.<ul><li>High School diploma or equivalent with minimum of 5 years relevant experience or an Associate&rsquo;s Degree with 2 years relevant experience or a Bachelor&rsquo;s Degree with a minimum of 1 year of relevant experience.</li><li>Strong math, communication skills and experience with MS Excel and database entry necessary. Prefer experience in clinical research, Finance, Outsourcing, Accounts Payable, or equivalent.</li><li>Strong knowledge of standard business procedures including contracting, finance, and budgeting.</li><li>Exercise appropriate judgment when prioritizing work tasks; Demonstrated ability to successfully manage projects to completion consistent with stated turn-around times and / or deadlines. Demonstrates analytical and critical thinking skills.</li><li>Operates independently and with minimal oversight.</li><li>Strong understanding of the overall Global Clinical Study process is preferred; Demonstrates developing knowledge of a clinical study protocol and ability to translate it into contractual payment terms.</li><li>Must be proficient in computer skills including Microsoft Office and have the ability to learn new software/technology quickly; knowledge of client systems and procedures (i.e. SAP, RAVE Electronic Data Capture, MIDAS, Quantum, Qlik, COMPASS etc.), including a thorough understanding of the payments process and systems is preferred.</li><li>Must have attention to detail and the ability to recognize and work with manager to resolve computational and contractual errors in contracts and invoices.</li><li>Well-developed communication skills and effective interaction with professionals, external sites, and vendors.</li></ul>Job Type: ContractPay: $22.00 - $23.00 per hourExpected hours: 40 per weekBenefits:<ul><li>Health insurance</li></ul>Education:<ul><li>Bachelor's (Preferred)</li></ul>Experience:<ul><li>Procurement: 2 years (Preferred)</li><li>purchase order: 2 years (Preferred)</li><li>Reconciliation: 2 years (Preferred)</li><li>invoice: 2 years (Preferred)</li><li>SAP: 2 years (Preferred)</li><li>contract management: 2 years (Preferred)</li></ul>Ability to Commute:<ul><li>North Chicago, IL 60064 (Preferred)</li></ul>Work Location: In person

Procurement Specialist (Invoice/Reconciliation/SAP/Purchase) (Pharma/Medical Device/Healthcare)

<div>Company Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. 
Job Description 
Purpose:
AbbVie is looking for a Sr. Systems Engineer to join their Combination Product Development team. This individual will contribute to the development and launch of exciting new drug / device combination products.
As a Sr. Systems Engineer, you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance.
Responsibilities:
You will be responsible for working across engineering teams to lead and drive the following:<ul><li>
User and Stakeholder Needs Definition</li><li>
System Architecture &amp; Integration</li><li>
Use Case Analysis</li><li>
Traceability</li><li>
Standards Coverage Analysis</li><li>
Risk Management Planning and reporting</li><li>
System Risk Assessment</li><li>
Use Error Risk Assessments</li><li>
System/Sub-System Requirements Definition</li><li>
Integration of Third-Party Development activities</li><li>
Integration of Drug Product Development activities</li><li>
Design Validation</li></ul>
In addition, you will be responsible for contributing to broadening the understanding and implementation of appropriate systems engineering principles within AbbVie. It is expected that the systems engineering activities for which you will be responsible may be done internally and externally. The external systems engineering activities will require you to develop and foster relationships with these external Engineering Services firms and third-party development partners who may be in Europe, India, Asia, and US, and in addition to regular WebEx/teleconferences, will require periodic face-to-face visits. You will be responsible for providing technical leadership in your areas of responsibility and ensure the systems design and documentation meet all safety and regulatory compliance requirements.
Preferred Qualifications:<ul><li>
Leadership experience is required that includes the ability to influence and negotiate internally and externally as a part of global engineering teams.</li><li>
Experience through full product development from initial concept to release to market is required.</li><li>
Expertise in design and development processes that conform to standards including IEC 60601, ISO 14971, IEC 62304, 11608, and the ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and MDR.</li><li>
Experience is required in user and stakeholder need definition; requirements definition; risk management, product architecture.</li><li>
The candidate must have strong analytical and communication skills. In addition, they must have experience with requirements management tools, V-model implementation, context diagrams, architecture diagrams, and interface management.</li><li>
The candidate should be familiar with device design controls, system decomposition, operational simulations, error budgeting, sensitivity analysis.</li><li>
Other attributes include strong analytical, decision making and communication (spoken and written) skills. It is expected that you will create and manage project schedules and help identify project risks and develop mitigation plans.</li></ul> 

Qualifications 
<ul><li>
Bachelor&rsquo;s Degree or equivalent education and typically 12 years of experience, Master&rsquo;s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience.</li><li>
Possess thorough theoretical and practical understanding of own scientific discipline.</li><li>
Effective writer and communicator of research or other regulatory materials.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li><li>This job is eligible to participate in our long-term incentive programs
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Senior Electromechanical Systems Engineer

<div>Company Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. 
Job Description 
The Director, Statistics II, Oncology provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients.
Responsibilities:<ul><li>
Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead statistical strategy for project development and regulatory submission.</li><li>
Direct and review the development of design, analysis and reporting for clinical or other scientific research programs. Review protocols, statistical analysis plans, and statistical programing plans.</li><li>
Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Represent DSS on data monitoring committees. Build interdepartmental relationships.</li><li>
Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.</li><li>
Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.</li><li>
Train and mentor staff on statistical methodology and operations. May supervise a group of statisticians as a people manager. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.</li><li>
Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.</li><li>
Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities. Build external scientific connections which foster professional development and promote the reputation of the Statistics department.</li><li>
Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Represent DSS in discussions with regulatory agencies and on Advisory Committees. 
Develop an external presence within the statistics community and represent abbvie on advanced and emerging topics.</li><li>
This role will work a hybrid work schedule from our North Chicago, IL, South San Francisco, CA offices.</li></ul>
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required 
Qualifications 
<ul><li>
MS (with 14+ years of experience) or PhD (with 10+ years of experience) in Statistics, Biostatistics, or a highly related field.</li><li>
High degree of technical competence and excellent communication skills, both oral and written</li><li>
Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others</li><li>
Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo</li><li>
Possess strong leadership &amp; project skills and experience in working/managing cross-cultural or global teams.</li><li>
Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.</li><li>
Extensive end-to-end (from conception of protocols to successful regulatory submission/approval) oncology and/or hematology drug development experiences as indications or compound lead</li><li>
Passionate about finding fit-for-purpose solutions to overcome challenges encountered in oncology drug development</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li><li>This job is eligible to participate in our long-term incentive programs
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Director, Statistics II - Oncology (Office-based)

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