Regulatory Affairs Associate Consultant Plm in United States

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Omnicare is a leading provider of pharmacy services to long-term care facilities nationwide, supporting skilled nursing facilities, assisted living communities, and other institutional care settings. Following the sale of Omnicare by CVS Health, this role will support Omnicare and its continued operations as an independent, standalone organization. Candidates should be aware that this role will not remain within CVS Health following the transaction. The individual hired into this role will be employed by Omnicare and will contribute to shaping the future of our organization during this exciting period of growth and transformation. Position Summary: Looking for a career that rewards you? As a Back-End Pharmacy Technician with Omnicare, you will not only find rewarding work in your community, but a team focused on providing a supportive and innovative team environment for all members. Day In The Life: As an Back-End Pharmacy Technician, you will work to ensure all medication needs and regulatory standards are met for our patients. You will work in various workstations allowing you to grow your skillsets further. Our back-end team focuses on order fulfillment in our closed-door pharmacy setting, including packaging and dispensing of medication, reviewing delivery orders and bins for accuracy, and coordinating stock rotations. Additio

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Omnicare is a leading provider of pharmacy services to long-term care facilities nationwide, supporting skilled nursing facilities, assisted living communities, and other institutional care settings. Following the sale of Omnicare by CVS Health, this role will support Omnicare and its continued operations as an independent, standalone organization. Candidates should be aware that this role will not remain within CVS Health following the transaction. The individual hired into this role will be employed by Omnicare and will contribute to shaping the future of our organization during this exciting period of growth and transformation. Position Summary: Looking for a career that rewards you? As a Back-End Pharmacy Technician with Omnicare, you will not only find rewarding work in your community, but a team focused on providing a supportive and innovative team environment for all members. Day In The Life: As an Back-End Pharmacy Technician Omnicell Driver, you will work to ensure all medication needs and regulatory standards are met for our patients. You will work in various workstations allowing you to grow your skillsets further. Our back-end team focuses on order fulfillment in our closed-door pharmacy setting, including packaging and dispensing of medication, reviewing delivery orders and bins for accurac

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Omnicare is a leading provider of pharmacy services to long-term care facilities nationwide, supporting skilled nursing facilities, assisted living communities, and other institutional care settings. Following the sale of Omnicare by CVS Health, this role will support Omnicare and its continued operations as an independent, standalone organization. Candidates should be aware that this role will not remain within CVS Health following the transaction. The individual hired into this role will be employed by Omnicare and will contribute to shaping the future of our organization during this exciting period of growth and transformation. As a Delivery Driver for Omnicare Pharmacy, you will deliver prescription orders and/or products to customers on a predetermined route and schedule in a company provided vehicle. Delivery Drivers take important steps to ensure all medication needs and regulatory compliance standards are met for our patients and they demonstrate ethical conduct and always maintain patient confidentiality. Successful Delivery Drivers will utilize a customer service mindset to manage all assigned pharmacy workstations and tasks to support the team’s ability to fill patient prescriptions promptly, safely and accurately. Provide timely and accurate delivery of medication, equipment, products and/or supplies into long term care facilities or patient’s homes Load products/mate

Our vision is to transform how the world uses information to enrich life for all . Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. The US Expansion Construction team is driving some of the most significant semiconductor manufacturing projects in the United States, including two high-volume manufacturing facilities in Boise, Idaho (ID1 and ID2) and a greenfield manufacturing facility in Clay, New York. Our team partners across engineering, construction, commissioning, and operations to deliver world-class facilities that support the future of technology and innovation. As the ID Quality Assurance Lead, you will be a key member of the US Expansion Strategic Programs team, reporting to the ID Sr. Commissioning Manager. In this highly visible role, you will lead quality governance across major capital projects, ensuring compliance, commissioning readiness, documentation integrity, and operational turnover excellence. You will serve as the primary owner-side quality leader, collaborating with contractors, vendors, inspection agencies, operations teams, and regulatory stakeholders to deliver successful project outcomes. Responsibilities: Lead quality governance, performance metrics, audit programs, reporting, and continuous improvement initiatives across Idaho capital projects Oversee contractor and vendor quality execution, including quality plans, inspections, testing, material verification, hold points, and compliance with project requirements Manage special inspection programs, testing agency coordination, regulatory interfaces, and turnover-ready quality documentation Align construction quality activities with co

Mid-Level or Senior Aerospace Systems Safety Engineer Company: The Boeing Company The Boeing Defense Air Dominance Division Systems Safety & Mission Assurance organization is looking for an Aerospace Systems Safety Engineer to join our team in Hazelwood, MO . Our teams are currently hiring for a broad range of experience levels including Experienced (Level 3) or Senior (Level 4) Aircraft Safety Engineers. A successful candidate will perform system software safety engineering work on a Proprietary Air Dominance program, drive hazard analyses, demonstrate compliance to MIL‑STD‑882E and other standards, and influence system architecture to reduce safety risk. The selected candidate will provide technical guidance and perform critical Software System Safety Engineering work. In addition to working with System Safety personnel, the individual will work extensively with design, development, and test to incorporate robust safety features and reduce project safety risk. Primary responsibilities: Analyzes the integration of complex airplane systems and their corresponding airplane-level effects, failure indications, and flight crew actions as part of a system of systems analysis Documents safety analyses, hazard mitigation, validation, and verification activities in compliance with relevant customer and regulatory safety standards such as MIL-STD-882E, MIL-HDBK-516C, AC-17-01, DO-178C, and DO-254. Demonstrates safety hazard risk mitigation and control methods to the customer and regulators Identifies safety issue systemic root causes and recommends corrective actions using industry best practices Collaborates with internal and external stakeholders to define, validate, and inte

Position Overview At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture where all of our employees feel respected, valued and have an opportunity to contribute to the company’s success. As a Project Manager III within PNC's Technology organization, you will be based in Pittsburgh, PA; Cleveland, OH; Phoenix, AZ; Dallas, TX; or Birmingham, AL. We are seeking a highly motivated Project Manager III to lead medium to large-scale projects and strategic initiatives. This individual will be responsible for managing complex projects from initiation through implementation, partnering with cross-functional stakeholders to deliver business outcomes while ensuring compliance with regulatory requirements and organizational standards. The ideal candidate will have experience leading projects in highly regulated industries. Key Responsibilities: • Lead multiple concurrent projects, ensuring delivery within scope, schedule, and budget. • Develop comprehensive project plans, timelines, governance structures, and stakeholder communication strategies. • Partner with business leaders, technology teams, risk partners, compliance organizations, and o

Logistics Analyst Description - Location: Fulltime onsite Hagerstown, MD Role Summary The Outbound Operations Lead / Analyst is the on-site expert who orchestrates all shipping activities- picking, packing, staging, loading, and system transactions within HP’s distribution operations. Blending shop-floor coordination with advanced analytics, the role ensures that every order departs safely, on time, and in full. Working side-by-side with 3PL partners, Transportation, Customer Support, and IT teams, this individual contributor drives day-to-day execution while uncovering process improvements that elevate customer experience, cost efficiency, and compliance. This position will work fulltime onsite at our east coast DC in Hagerstown, MD. Key Responsibilities Oversee daily outbound operations, ensuring accurate and timely order fulfillment, packing, and shipping in line with HP’s quality and service standards. Lead and support process improvement initiatives focused on optimizing outbound flow, reducing order cycle times, minimizing shipping errors, and enhancing on-time delivery performance. Collaborate with Supply Chain, Customer Service, Warehouse, IT, and Transportation teams to coordinate outbound shipments, resolve exceptions, and ensure alignment with customer requirements. Track real-time metrics such as pick accuracy, order fill rate, on-time ship, trailer utilization, and dock-to-door cycle time; initiate immediate countermeasures when performance drifts. Serve as the primary point of contact for order expedites, configuration changes, embargo checks, and any customer-facing shipment issues. Develop and maintain SOPs for outbound operations, ensuring compliance with company policies and regulatory requirements. Perform ou

ROLE SUMMARY The primary purpose of this job role is to function as a member of the Sample Logistics (SL) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for receiving samples from global clinical/study trials according to approved protocols and processes. The individual will participate in all aspects of tracking and documenting the chain of custody of samples. The incumbent’s role will include sample receipt, documentation, storage, tracking, aliquoting, distribution to the testing labs, and sample disposal. The colleague will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager. ROLE RESPONSIBILITIES The incumbent will be required to complete all processes as detailed in Sample Management’s Standard Operating Procedures. The colleague will perform job responsibilities in compliance with GXP and all other regulatory agency requirements. The candidate will receive samples from clinical trial sites and enter samples into an electronic database management system. Performs sample storage and retrieval using manual freezers and BiOS (automated freezer storage system). Performs manual sample aliquoting and aliquoting using the Hamilton robotic instrument. <span style="color:#

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Senior Scientist, Purification Process Development (Pivotal & Commercial) role will be responsible for leading aspects of purification development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead/support technology transfer, participate in purification and cross-functional initiatives, and support purification regulatory documentation. Key Responsibilities: Design experiments and demonstrate hands-on technical leadership of all aspects of purification process development including chromatography, TFF, virus f

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Job Responsibilities: Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements - supervises QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews. Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Reviews manufacturing, environmental monitoring and q

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description The Senior Manager, Kite Safety and Pharmacovigilance provides scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products. This role serves as a senior pharmacovigilance science expert, leading complex safety analyses, regulatory deliverables, and cross-functional safety strategy execution. Key Responsibilities Aggregate Reporting and Medical Writing Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs, synthesizing global safety data and clinical context Author and review high-impact safety documents supporting regulatory submissions and lifecycle management Safety Analysis and Signal Management <

Job Title Field Service Engineer, Multimodality Imaging (Travel: Honolulu, HI) Job Description Allow your passion for improving lives to shine in this role where you’ll be responsible for customer relationship management through the effective use of technical knowledge to install, troubleshoot, service, and maintain equipment at customer sites. Considering candidates who are willing to relocate to Honolulu, HI. Your role: Provide exceptional customer service by adhering to customer entitlements, setting clear expectations, and meeting commitments and arrival times to address and resolve customer needs. Understand the customer's business and competitive environment; generate service revenue. Actively participate as a member of the regional work team; work to improve team processes and identify training gaps. Seek out opportunities to increase capability and capacity (i.e. may be required to become qualified in multiple modalities, learns new tools). Perform all administrative duties within established Philips, State, and Federal regulatory requirements and timeframes including timesheets, service work orders, expense reports, Field Change Orders (FCO), preventative maintenance (PM), installation documents, site and service documentation, and other related paperwork. Adhere to established training, quality, and safety requirements. Utilize tools, support, resources, and escalation processes within required time frames to resolve customer and system problems timely and effectively. Complete PMs, FCOs, installation and all related tasks (diagnose and resolve electronic, network, and mechanical problems). Approximately 70% travel across the specified geography is required. The average driving time is 1-4 hours daily. Occasional overnight stays and travel by air and/or train may be required. You're the right fit

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Associate, Packaging Your Role at Baxter This is where your work helps create life-sustaining products. As a Packaging Associate at Baxter, you will support the production of high-quality medical devices by performing packaging and final assembly activities for our Blood Pressure Cuffs product line. In this role, you will help ensure products are packaged accurately, safely, and in compliance with quality and regulatory standards before reaching our customers. Working as part of a collaborative manufacturing team, you will contribute to efficient production operations, maintain inventory and material flow, support continuous improvement initiatives, and help uphold Baxter's commitment to quality, safety, and patient care. What You'll Be Doing Package cuffs and other finished products coming from the production line according to established work instructions. Package, label, and prepare component parts and assemblies for shipment while ensuring product protection and completeness. <l

Job Details: Job Description: The Role and Impact As a Facilities Mechanical Technician, you will play a pivotal role in maintaining and optimizing Intel's state-of-the-art facilities. Your work will directly support Intel's mission to shape the future of technology by ensuring the reliability, efficiency, and safety of mechanical systems that power manufacturing, research, and development. You will collaborate with cross-functional teams and leverage your technical expertise to troubleshoot, repair, and maintain complex mechanical and HVAC systems. This is an opportunity to contribute to Intel's innovative environment and help us build a sustainable future by designing and operating systems aligned with our environmental goals. Key Responsibilities Perform repairs and preventative maintenance on a wide range of mechanical systems, fixtures, and equipment, including HVAC, plumbing, and process systems. Troubleshoot and resolve operational issues with industrial systems, including pumps, piping, air handlers, boilers, chillers, and exhaust systems. Conduct routine inspections and ensure compliance with regulatory requirements while maintaining a strong focus on safety and environmental standards. Assist in the design, analysis, and enhancement of mechanical systems and equipment to optimize performance and reliability. Partner with internal customers and operations teams to deliver engineering solutions that support facility operations and manufacturing processes. Support development and execution of mechanical systems roadmaps, ensuring capacity and redundancy for expansion projects, renovations, and facility growth. Provide technical input to drafting teams for design documentation, testing, and prototype fabrication. </

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary Reviews and adjudicates complex, sensitive, and specialized medical claims in accordance with established plan processing guidelines. Functions as a subject matter expert by providing coaching, and offering guidance on escalated or technically challenging issues. Supports customer service operations by addressing inquiries and resolving issues to ensure a positive member experience. Additional Responsibilities - Reviews pre‑specified claims and those that exceed specialist adjudication authority or processing expertise. - Applies medical necessity guidelines, determines coverage, verifies eligibility, identifies discrepancies, and implements cost‑containment measures to support accurate claim adjudication. - Ensures compliance with all regulatory requirements and confirms that payments align with company policies and procedures. - Identifies and reports potential overpayments, underpayments, and other claim irregularities. - Performs claim rework calculations as needed. - Trains and mentors as needed to enhance team performance and technical proficiency. - Conducts outbound calls to obtain required information for claims or reconsideration requests. Required Qualifications - Minimum of 18 months of medical claim processing experience with a health insurance payor or third‑party administrator. - Proven