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job summary: Step into a high-impact leadership role where you will safeguard the integrity of life-changing medical technologies. As the Manager of Design Quality for Lifecycle Management, you will be the primary driver for quality and compliance, overseeing product transfers and on-market change management for a diverse portfolio including infusion pumps, autoinjectors, and aesthetic devices. This is a chance to lead cross-functional teams through complex design control and validation activities, ensuring that every product reaching the patient meets the highest global regulatory standards. The work is performed at a world-class, state-of-the-art innovation hub in North Chicago that houses cutting-edge R&D labs and advanced manufacturing support, fostering a collaborative environment dedicated to complex therapeutic solutions. You will play a pivotal role in bridging the gap between development and manufacturing,   location: North Chicago, Illinois job type: Contract salary: $95.00 - 104.96 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Lead Design Transfer & Change Management: Serve as the primary Quality lead for design transfer activities and on-market design changes, ensuring seamless transitions from development to manufacturing both internally and with external partners. Drive Validation Excellence: Lead and support comprehensive process validation activities, including IQ/OQ/PQ/PPQ and Test Method Validation (TMV), to ensure robust manufacturing processes. Oversee Design Controls: Own and manage Change Plans, ensuring all design control documentation, traceability, and linkages remain compliant throughout the product lifecycle. Manage Risk & Compliance: Identify and remediate gaps within the Design History File (DHF) and Risk Management files, tracking all improvements and mitigations to closure. Cross-Functional Leadership: Mentor product team members through the design control process and lead solution development for complex quality system improvements. Audit & Inspection Support: Act as the Subject Matter Expert (SME) for Quality Assurance during internal audits and external regulatory inspections (FDA/EMA).  qualifications: Required Skills Education: Bachelor's degree in Engineering, Science, or a related technical field. Experience: Minimum of 8 years in the medical device or combination product industry, with at least 5 years specifically in Quality Assurance. Regulatory Mastery: Deep working knowledge of 21 CFR 820, 21 CFR 4, ISO 13485, ISO 14971, and EU MDR (2017/745). Technical Proficiency: Solid understanding of Design Control principles, Change Control, and Risk Management. Validation: Hands-on experience with process validation (IQ/OQ/PQ) and TMV. Preferred Skills Advanced Education: Master's degree in a technical or business field. Certifications: ASQ certifications such as CQA, CQE, or Six Sigma Black Belt (SSBB). Product Expertise: Direct experience with Infusion Pumps, Pre-filled Syringes (PFS), Autoinjectors, or On-Body Injectors. Supplier Quality: Experience assisting 3rd party suppliers with change management strategies. #LI-BM1   skills: OQ, Corrective and Preventive Actions (CAPA), Deviation Investigation, Process Validation, Change Control Management, Quality Assurance (QA) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.

Randstad, the world's leading partner for talent, is investing in an Account Manager for our Randstad Digital specialty. As an Account Manager, you will be responsible for driving new business through direct client engagement, territory planning, and selling our services. We prioritize building lasting relationships with clients and candidates, aiming to deeply understand their needs for mutual success. What you get to do: Analyze market trends, leverage industry expertise, and strategically position Randstad Digital to maximize growth potential within a key segments. Brand Randstad Digital accurately as the world’s leading partner for talent through relationships Leverage your industry knowledge, experience, and thought leadership to envision how technology can transform our customer’s business to drive higher levels of customer experience and engagement. Serve as an expert business consultant within an industry segment. Optimize & amplify current relationships by actively engaging with clients as their primary point of contact. Exploit Randstad Digital’s existing strengths to be recognized as the primary driver of digital transformation in the areas of cloud and infrastructure, customer experience, data & analytics, and digital & product engineering. Work closely with project/program management to ensure successful delivery through an integrated delivery model. Establish and cultivate strong relationships with your client at senior levels as well as external and internal partners to maximize growth within an account. Lead the execution of new agreements aimed at surpassing revenue and margin expectations. What you need to bring: 3 years of selling technical products Proven history of expanding services within assigned accounts. Skill in cultivating enduring relationships founded on principles of integrity. Outstanding abilities in communication, presentation, and influence. Strong problem-solving and creative thinking capabilities. Strong negotiation skills. A history of outperformance A Bachelor’s degree is advantageous Proficiency using Google mail, calendaring and shared drives Randstad Digital operates in a hybrid work model in areas where we have offices. There should be no expectations that this is a full time remote role, even in areas where we have no offices at the time of hire. You are expected to comply with our hybrid work policy and guidelines. This job posting is open for 4 weeks. Randstad offers competitive pay and bonus structures. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. Based on eligibility, a successful candidate's total compensation may include a variable pay plan including bonus(es) and/or commission(s). In setting compensation, Randstad complies with all local wage and hour laws and while the pay range listed above is an annual amount, non-exempt employees will be paid hourly and therefore receive the hourly equivalent. In addition, Randstad, the largest global staffing leader, offers rich learning & professional development opportunities, a 401(k) plan, a stock purchase plan, an employee referral reward program, and comprehensive medical, dental, vision, disability and life insurance to uniquely fit your needs. Randstad also focuses on our employees' overall wellbeing with our award-winning wellness program, employee assistance program, a generous time off policy (including at least 18 paid days off in your first full year, 1 paid volunteer day, 9 paid holidays, and 5 sick days), paid parental leave, paid caregiver leave, a health and dependent care flexible spending account, Metlife home and auto insurance offerings, a Metlife legal plan offering, and offers discounts on everything from cell phone plans to car purchases. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. We are seeking candidates from all backgrounds and demographics and a variety of industries to join our winning team! Randstad is proud to be included in the prestigious "America's Best Employers for Women 2024" list. Randstad US has also been recognized as a 2024 Leading Disability Employer by the National Organization on Disability (NOD). At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact hrsupport@randstadusa.com.  

job summary: This is a high-impact opportunity to shape the future of oncology drug development by ensuring the patient's voice is at the center of clinical research. You will lead the strategy and execution of Patient Experience Data (PED), transforming complex clinical outcomes into compelling evidence that drives product registration and global market access. Working within a specialized research team, you will bridge the gap between rigorous statistical analysis and strategic clinical development. You will be joining a world-class research facility renowned for its cutting-edge oncology pipeline and commitment to patient-centric innovation. This remote-based role offers the chance to work at the forefront of measurement science, utilizing advanced psychometric and statistical methods to validate Clinical Outcome Assessments (COA) that directly impact lives.   location: Telecommute job type: Contract salary: $50.00 - 55.32 per hour work hours: 9 to 5 education: Masters   responsibilities: Lead COA Strategy: Design and integrate Clinical Outcome Assessment measurement strategies into clinical development programs, ensuring they are fit-for-purpose and regulatory-ready. Execute Quantitative Research: Conduct rigorous psychometric and statistical analyses, including factor analysis and reliability testing, to validate PRO/COA tools within oncology portfolios. Drive Clinical Integration: Collaborate with Clinical Development and Operations to author protocols and Statistical Analysis Plans (SAPs) that incorporate patient-centered endpoints. Regulatory Authoring: Develop high-level technical content for regulatory and reimbursement submissions, translating complex data into clear, persuasive narratives. Evidence Generation: Conduct literature and landscape reviews to build disease conceptual models that define the patient experience in specific oncology indications. Scientific Communication: Lead the publication process and present data-driven insights at major medical congresses and in peer-reviewed journals. Stakeholder Education: Act as a subject matter expert to internal teams, promoting best practices for quantitative PED/COA analysis across the organization.  qualifications: Required Skills: Advanced degree (MS, MPH, PharmD, or PhD) in Biostatistics, Epidemiology, HEOR, Public Health, or a related quantitative field. Minimum of 3 years of direct research experience with hands-on quantitative and statistical analysis of PRO/COA data within clinical trials. Expertise in measurement science principles and advanced psychometric/statistical methods. Proven experience developing and implementing Statistical Analysis Plans (SAPs) for clinical outcomes. Strong project management skills with the ability to manage multiple competing priorities in a fast-paced environment. Preferred Skills: Direct experience in Oncology research or oncology-specific PRO/COA validation. Familiarity with regulatory documentation requirements specifically for COA endpoints. Advanced statistical programming skills related to clinical trial endpoint analysis. #LI-ST1   skills: Project Management, Oncology, Data Analysis, Statistical Analysis Plan, Statistical Programming, Economic Modeling, Health Economics, Real World Evidence (RWE), Cost Effectiveness, Budget Impact Modeling, Health Technology Assessment (HTA), Outcomes Research, Pharmacoeconomics, Systematic Literature Reviews (SLR), Meta Analysis and Indirect Treatment Comparison, Cost Benefit Analysis, Cost Utility Analysis, Patient Reported Outcomes (PRO), Observational Study Design and Execution, Claims Database Analysis, Electronic Health Record (EHR), HEOR Endpoints, Evidence Synthesis, Value Proposition Development, Market Access Strategy Support, Payer Engagement and Communication, Burden of Illness Studies, Quality of Life (QoL), Global Payer Landscape Understanding, Evidence Generation Planning Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.