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QuintilesIMS jobs in Raleigh, NC - 115 jobs

  • Scientific Advisor, Medical Communications

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    and candidates must be US-based. Travel required 10-20%._ The Scientific Advisor is responsible for optimizing the customer relationship, developing, and delivering content according to client strategy and branding objectives. Primary responsibilities include the management of projects, development of high-quality scientific content, partnering with stakeholders to meet objectives, and ensure that client needs are met in a timely manner. **Responsibilities:** Project Management + Responsible for overall strategic management and content ownership of complex, highly visible projects on specific accounts including coordination of digital and interactive content, working with content experts to validate scientific accuracy, project goals, and timelines. + Develop creative concepts, independently prepare, and deliver client presentations in a manner that effectively showcases the featured content as directed by client, and Key Opinion Leaders (KOLs). + Drive long-term planning of assigned accounts including timelines, quality assurance, SOP creation and adherence, and budget monitoring. + Collaborate with internal project team members to ensure client expectations are being met. + Monitor projects to guarantee adherence and pull-through of client strategy. + Synthesize client feedback for implementation by project team members. + Track and report on all opportunities, key milestones, support requirements, etc in Basecamp. + Manage and attend and lead (as-needed) relevant internal meetings, as assigned. + Contribute to enhanced customer service through timeliness and quality of communications and deliverables, including thorough hand-offs to internal project teams. + Develop and maintain working knowledge of managed products, and disease areas and the competitive landscape. + Develop and assist with preparation of client pitches, presentations, and metrics. + Manage faculty recruitment, engagement, and relationships on behalf of clients. + Participate in internal brainstorms, key client strategy and planning sessions, and Summit Global Health strategy/planning sessions. Development of Scientific Content + Authors/supports publication and presentation of product and disease state information in support of client strategy. + Designs and leads the content strategy for Summit Global Health with clients. + Creates and presents content in a variety of media in support of client strategy and objectives. + Review technical documents to ensure regulatory compliance in all content created. + Identifies, develops, recommends and/or negotiates scientifically sound, creative solutions to meet clients' critical business needs. + Monitors the competitive therapeutic landscape for each client to evolve content strategies for differentiation. + Critically reviews technical and scientific reports from external sources for inclusion as a resource for content development. + Reviews clinical regulatory documents and communications. + Understands trends in the scientific communication landscape for data visualization and creative social/digital content trends that Summit Global Health can consider leveraging. Client Relations and Management + Manage the client relationship, setting clear expectations around deliverables and project plans. + Maintain regular contact with client to ensure expectations are met. + Plan, schedule, organize team members, and prepare client update agendas and summaries to facilitate and lead client update meetings. + Synthesize client feedback for implementation by project team members. + Collaborate with internal project team members and departments including Scientific Services, Interactive, and Marketing to ensure client expectations are being met. + Track and report on all opportunities, key milestones, support requirements, etc. + Play key role in new business development including brainstorming client solutions, pitching new business, supporting pitch presentation development, and organizing client kickoff meetings. Brand Management + Establish meaningful, professional relationships with various client stakeholders, including gaining understanding of their individual roles, communication preferences, personal motivators, and the desired outcomes for the brand and for the team. + Ensure The SGH brand is properly represented and promoted throughout client interactions, communications, and deliverables. + Promote and deliver service levels which are sustainable and allow for efficient delivery of a quality product. + Provide data, decisions, and delivery of services in support of client, project, and community success. **Requirements:** + **PhD (preferred) or PharmD with relevant concentration.** + **3-5 years of experience in a medical communications agency.** + Relevant therapeutic background. + Strong knowledge of medical information resources and how to access and extract key information + Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required. + Excellent written and verbal communication and presentation development skills. + Data analysis and data visualization skills. + Ability to multitask and prioritize projects effectively. + Solutions-oriented, with excellent organizational skills. + **Ability to travel for representation of company at client meetings, advisory boards, medical or industry conferences, pitch presentations, and other meetings as needed.** IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $95,100.00 - $237,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $95.1k-237.7k yearly 60d+ ago
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  • QA Auditor

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    Provide global regulatory oversight of validation management as part of the Quality Management System. This oversight includes developing IQVIA Laboratories policy and procedure related to GxP compliance, guidance, audit support, review of validation deliverables, and approving release for use as related to Laboratory System Validations. **RESPONSIBILITIES** **Essential Functions** - Plan, schedule, conduct, report, and close Clinical Trial Laboratory Technology Systems Audit activities in IQVIA globally, or its affiliates, to assess compliance with applicable GXP regulations/ GAMP (Good Automated Manufacturing Practices) guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions. Thorough auditing evaluates the proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and Technology in general. - Evaluate audit findings and prepare and distribute reports to operations staff and management and ensure associated corrective/preventive actions (CAPA) are followed up on and implemented. - Manage/oversee quality events updates in the electronic quality management system (eQMS) and/or maintain the eQMS and provide support in relation to the audit lifecycle. - Perform independent compliance review of pre-validation deliverables and post-validation documentation - Manage Quality Issues. Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities. - Keep current with regulatory developments, including GxP, 21 CFR Part-11, EU Annex 11, GAMP, ICH, risk management, corporate policies and procedures, etc. to ensure IQVIA meets or exceeds industry's best practices for compliance and validation. - Collaborate with other IT members, QA, and business functions on validation of new systems and improvement of existing IT Quality processes/practices. - Provide consistent interpretation and implementation of regulatory controls to project teams on regulations, guidelines, compliance status, and policies and procedures. - Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. - Lead/collaborate/support in QA initiatives/projects for quality, process improvements. **Minimum Required Education and Experience** - Bachelor's Degree - 3+ years of Quality Assurance experience - Experience with QLIMS, ULTRA, Chromeleon, Spectrophotometer, Top CAT, and ABI Sequencers - GXP experience - Or equivalent combination of education, training and experience. - Experience Hosting Client or 3rd Party On-Site Audits and Conducting Internal Audits of various Clinical Trial Quality Sub Systems, including managing organizational responses to client or 3rd party audit reports. - Experience working in auditing and compliance of Computer Systems within an FDA regulated environment, such as Clinical Trials, or within a SaaS provider whose products target FDA regulated companies and whose products must be able to be validated to be compliant with 21CFR Part 11. - Expert knowledge of Computer Systems Validation (CSV) in a life science or regulated environment required. - Experience with software validation and testing methodologies, documentation and product specifications in an FDA regulated environment such as pharmaceutical, biotech or medical device required. - Knowledgeable in the following regulations/regulatory guidelines: 21 CFR Part 11, Electronic Records - Electronic Signatures; General Principles of Software Validation - Final Guidance for Industry and FDA Staff; Good Automated Manufacturing Practices (GAMP) guidelines; or other methodologies for Computer Systems Validation in a regulated environment and Data Integrity requirements. - Comprehends GxP computerized systems documentation such as validation plans, requirements and specifications, risk and gap assessments, test plans, qualification protocols, phase reports and summary reports. Additional Work Experience - 3-6 years of experience in CRO, Pharmaceutical, Biotechnology, Technical, or related area **Skills and Abilities** - Skilled at PowerPoint, Excel, Project Management and other similar tools. Experience with SharePoint and Smartsolve is a plus. - Effective organization, communication, and team orientation skills. - Ability to manage multiple ongoing projects and deadlines. - Excellent written and oral communication skills. - Strong level of detail, problem solving, and organizational skills. - Strong training capabilities. - Ability to initiate assigned tasks and to work independently. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $54,200.00 - $135,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $54.2k-135.4k yearly 13d ago
  • Point of Care Solution Specialist - Hospital Sales - Raleigh, NC

    Abbott 4.7company rating

    Raleigh, NC job

    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'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with a high employer contribution + Tuition reimbursement, the Freedom 2 Save (******************************************************************************************************* student debt program, and FreeU (*************************************************************************************************************** education benefit- an affordable and convenient path to getting a bachelor's degree. + A company recognized asa great placeto work in dozens of countriesworldwide andnamed one of the most admired companies in the world by Fortune. + 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. **Abbott Point of Care** (APOC) is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry's most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance. **The Opportunity** We are hiring a **Point of Care Solutions Specialist** in our **Abbott Point of Care** **(APOC)** **Division** selling to hospitals in E. North Carolina **.** The Point of Care Solution Specialist works independently within an assigned territory leading commercial execution to increase market share and drive sustainable growth. Working in a collaborative environment, the Sales Specialist will partner with internal support team members to identify opportunities and create strategies that move sales cycles forward. The position reports to the District Manager and requires up to 50% travel to provide customer-focused service and effectively support business goals. **What you will work on** + Achieve sales targets through efficient and effective sales cycle and territory management. + Maintain sales base while closing new business in both new and existing accounts. + Efficientlynavigate complex sales environments with multiple stakeholders and dynamic decision-making criteria,whilealso buildingrelationships. + Develop and execute sales strategies, whileanticipatingpotential risksand proactively developing and implementing mitigation plans. + Utilize available resources effectively. + Ensure that all administrative tasks (i.e., training modules, expense reports, sales forecasts, etc.) are completed promptly and accurately. + Travel within assigned territory is up to 50% and will provide customer-focused service and effectively support business goals. some regional, overnight travel isrequired. + Understands andcomplies withall applicable EHS policies,procedures,and guidelines. + Responsible for implementing andmaintainingthe effectiveness of the Quality System. **Required Qualifications** + Bachelor's degree + 4+ years of relevant sales experience or 0-3 years of experience with a Clinical background (BSN, MLT, CLS, RT, Cardiac Tech, etc.) + Must reside in the territory and be able to travel up to 50% in assigned territory and other business locations (as necessary). **Preferred Qualifications** + Documented history of being a consistent sales overachiever (i.e., President's Club winner). + Consistently ranks among the top 20% in peer sales group. + Diagnostics, point of care (POC), lab, or capital equipment sales experience. + Hasestablishedcontacts at IDN's and Hospital Systems within assigned territory. + Possesses strong MS Office (Excel, PowerPoint, and Word) skills. + Highly proficient at usingthe Salesforce.com, or similar, CRM platform. + Attended multiple sales training courses (e.g., Challenger, Miller Heiman, etc.), andis an active user of one or multiple effective sales methodologies. **Learn more about our benefits that add real value to your life to help you live fully: ** ********************** (http://**********************/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ************** , on Facebook at *********************** and on Twitter @Abbott News and @AbbottGlobal. The base pay for this position is $68,000.00 - $136,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call ************ or email ******************
    $68k-136k yearly 37d ago
  • Direct Sales Representative, ICM - Charlotte/Raliegh/Wilmington, NC

    Abbott Laboratories 4.7company rating

    Raleigh, NC job

    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'll also have access to: * Career development with an international company where you can grow the career you dream of. * Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. * An excellent retirement savings plan with a high employer contribution · * Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. * 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. * 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. The Opportunity This position is a field-based position can be based in Charlotte; Raliegh; Wilmington, NC the ICM Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. What you will work on We are seeking a dynamic and results-driven Medical Sales Representative to join our team to promote and sell Abbott's Insertable Cardiac Monitor (ICM) medical devices. In this role, you will be responsible for promoting and selling ICM devices to physicians, medical laboratories, distributors, and hospitals within an assigned territory. Your efforts will contribute to the growth and success of Abbott's CRM product lines. Key Responsibilities * Contacts, visits and educates clients and potential clients on the Company's products and addresses any client questions and concerns. * Builds and executes on business plans in partnership with management to identify, target and develop new accounts. * Provides medical professionals with information and training on the use of Company products and with staff education, in-services and technical troubleshooting. * Ensures that all pertinent patient information is completed and forwarded to patient tracing when required. * Responsible for the management of physical inventory located within assigned territory. * Collects and studies information about new and existing products and monitors competitor sales, prices and products. * Analyses sales statistics; prepares reports; and performs required administrative sales duties, e.g., filing expense account reports, scheduling appointments, and making travel plans. * May attend trade shows where new products and technologies are showcased and conferences to meet other sales representatives and clients and discuss new product developments. * Prepares special analyses as required. * Remains current on developments in field(s) of expertise. * Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. * Performs related duties, on occasion, as assigned or required. Qualifications * Bachelor's degree in a relevant technical field or equivalent and typically two plus years of sales or clinical support experience with proven experience influencing customers in a healthcare-related setting. * An aptitude to analyze and evaluate technologically complex devices; ability to work with and direct others effectively; ability to prepare and present strong written and verbal communications; familiarity with medical device industry policies, operations and procedures. * Documented record and/or aptitude of delivering sales/marketing information to influence customer decision-making * Ability to establish and maintain good working relationships with customers, physicians, hospital administrators, government agencies, medical groups, and other sales representatives. * Strong verbal and written communication, negotiation, sales, interpersonal and presentation skills. Demonstrated working knowledge of frequently used personal computer programs and relevant applications. * Prefer general understanding of cardiac rhythm management technology. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** 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 *************** on Facebook at *********************** and on Twitter @AbbottNews. The base pay for this position is $43,900.00 - $109,200.00. In specific locations, the pay range may vary from the range posted.
    $43.9k-109.2k yearly Auto-Apply 4d ago
  • Associate/Director of Biostatistics, Rare Disease, FSP

    Iqvia Holdings Inc. 4.7company rating

    Iqvia Holdings Inc. job in Durham, NC

    Job Level: Associate/Director of Biostatistics, Rare Disease, FSP As an Associate Director, you will liaise with cross-functional teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries. Key Responsibilities: Leadership: * Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company. * Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee. * Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication. * Participate as high-level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries, and/or NDA sections. * Lead studies at an operational level. * Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures. * Consult on operational/statistical/therapeutic area topics. Knowledge Sharing: * Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses. * Perform as subject matter expert (SME). Risk Management: * Identify risks to project delivery and/or quality, lead in a way to minimize risks. * Anticipate risks to avert the need for study-level escalations, support lead in implementing risk mitigation actions. Lock and Unblinding Process: * Lead the database lock and unblinding process for the statistical team. * Participate on the biostatistics randomization team (draft randomization specifications and/or perform quality control (QC) review of randomization schedules). Statistical Expertise: * Provide expert statistical input into the review of statistical deliverables (i.e., statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports). * Provide expert input into data management deliverables (i.e., database design, CRF design, validation checks, and critical data). * Provide expert review of ADaM reviewers guide (ADRG) and metadata. * Perform senior biostatistical review (SBR). * Produce or perform quality control review of sample size calculations for complex studies. Requirements: * MS or PhD degree in Biostatistics or a related field and 8+ years' relevant experience within the life-science industry. * Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials. * Expert in strategically collaborating with clinical and drug development experts. * Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries. * In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines. * Strong working knowledge of SAS and R. * Excellent knowledge of CDISC Data Standards. * Superb communication and collaboration skills. * Independent and proactive problem-solving skills. * Rare disease and immunology experience is greatly preferred. #LI-Remote #LI-NITINMAHAJAN IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $161,100.00 - $299,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $161.1k-299.1k yearly 9d ago
  • Clinical Research Associate, IQVIA Biotech

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    **_IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring and will also consider CRA 1 candidates with a minimum of 6 months on-site monitoring experience. Must have experience monitoring in oncology solid tumor._** _IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster._ **Job Overview** We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data. **Key Responsibilities** + Conduct all types of site visits-selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines. + Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals. + Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues. + Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity. + Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries. + Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. + Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence. + Work closely with cross-functional project teams to support study execution and ensure alignment with project goals. + Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking. **Qualifications** + Bachelor's degree in life sciences or health-related field (or equivalent experience). + Requires at least 1 year of on-site monitoring experience. + Strong understanding of GCP, ICH guidelines, and regulatory requirements. + Ability to travel as required by the project. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $71.9k-169.3k yearly 35d ago
  • Plant Purchasing Supervisor - Altavista, VA

    Abbott Laboratories 4.7company rating

    Raleigh, NC job

    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. Plant Purchasing Supervisor 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'll also have access to: * Career development with an international company where you can grow the career you dream of. * Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. * An excellent retirement savings plan with a high employer contribution * Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. * 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. * 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. The Opportunity This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac, PediaSure, Pedialyte, Ensure, and Glucerna - to help them get the nutrients they need to live their healthiest lives. Altavista, Va., is one of Abbott's largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like you're part of a family that works together to make a difference and help nourish millions of families around the world. The Purchasing / Stockroom Supervisor leads the onsite MRO (maintenance, repair, and operations) warehouse. The warehouse, or "parts room", contains critical spare part and consumable items used in the manufacturing operation. In addition, the position leads the administration of site indirect procurement (non-raw materials). What You'll Work On * Manage the overall inventory process and system, including hours of operation, procedures for check-outs and returns, inventory and cycle counts, new add-to-stocks, master data (safety stocks, vendor lead time), etc… * Act as lead for Plant Purchasing (including issuance of site purchase orders in both Maximo(front for SAP) and Ariba, maintenance of price/quantity changes, and vendor maintenance). * Ensure all processes and systems comply with safety, quality, and finance procedures. * Lead and develop warehouse team members, including annual goal setting and performance reviews. * Be the site subject matter expert for the inventory software (Maximo). * Own the program for parts that get repaired and the kitting of parts used collectively in one job. * Partner with vendors on vendor management inventory. * Partner with Engineering and Maintenance teams on part obsolescence. * Manage operation with defined budget. * Achieve all applicable key metrics (stockout %, obsolescence %, blocked invoice aging, etc… ). * Assist with supplier selection. * Manage SOWs/RFI's/Ordering documents. * Manage day to day supply issues. * Communicate pertinent information to both internal customers and suppliers to keep apprised and to prevent problems. * Drive savings outcomes. Collaboration with functions. * Seek and support business relationships with diverse suppliers. * Communicate with appropriate departments to clarify request and obtain appropriate supporting documentation for the purchase using p-card. * Assure team members are trained and understand duties, responsibilities, and performance against established expectations. * Provide timely coaching, counseling and feedback. * Develop all line personnel by securing appropriate training, providing mentoring and assigning progressively challenging stretch responsibilities within the scope of the team and department accountabilities. * Execution of on time performance reviews for direct reports You'll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures. Required Qualifications * Bachelor's degree in accounting, business, science, food technology, engineering or equivalent combination of education and experience * Demonstrated leadership skills * Knowledge of project planning tools and experience using them * Proven plant financial understanding * Drive Continuous Improvement within the scope of work Preferred Qualifications * Previous experience working in a regulated manufacturing work environment with preference being for food, pharmaceuticals, medical devices, cosmetics, etc. * Experience utilizing project planning and execution tools * Green Belt Certification Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** 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 and a Military/Veteran friendly Employer, committed to employee diversity. Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews. The base pay for this position is $61,300.00 - $122,700.00. In specific locations, the pay range may vary from the range posted.
    $61.3k-122.7k yearly Auto-Apply 8d ago
  • Site Monitoring Lead

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    Site Monitoring Leads are accountable for authoring the monitoring risk assessments and plans, maintaining sponsor oversight, trend analysis, signal detection and delivery of their assigned trials in close collaboration with the IQVIA partner to provide delivery of the Sponsor's pipeline through accurate planning and efficient execution of Site Monitoring in trials that bring speed & value to participating subjects and sites. Provides Site Monitoring expertise to and consults the Trial Team, leads and oversees the implementation of the Site Monitoring & Oversight approach and activities as part of overall clinical trial quality management. The Site Monitoring Lead is accountable for managing the trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, and compliance with study protocol. **MAIN RESPONSIBILITIES** Trial Preparation: - Plan trial quality and risk monitoring/ mitigation as part of the Trial Team. - Deliver Risk-based Site Monitoring approach and training for the trial. - Accountable for the development of the operational Site Monitoring & Oversight plans. - Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates. - Act as an expert and consultant on Site management and monitoring topics. - Integrate patient/site level feedback to the documents ensuring design with a focus on the patient. - Provide timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee). - Facilitate communication and direction with CT Managers and IQVIA CRAs. Trial Conduct: - Monitor progress and oversee Site Management and Monitoring activities conducted by IQVIA partners during clinical trial conduct including adherence to ICH-GCP and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans. - Pre-identification of important protocol deviations from site deviations. - Continuous review, risk identification, evaluation and communication on a trial level. - Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents. - Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits). - Facilitate communication and training related to site monitoring in the trial. Trial Close-out: - Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries. - Support compilation and review of the quality section for the clinical trial report for site monitoring activities. **REQUIRED SKILLS AND QUALIFICATIONS** Bachelor's level degree in life sciences OR several years of equivalent professional education. - Solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities. - Fluent in English (written and spoken). - Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. - Demonstrates active listening skills and cultural awareness. - Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors. - Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $68.4k-171k yearly 42d ago
  • Senior Epidemiologist, Oncology, Breast Cancer, Real World Evidence - FSP (Sponsor Dedicated)

    Quintilesims 4.7company rating

    Quintilesims job in Durham, NC

    Join IQVIA's Sponsor-Dedicated FSP team and help advance healthcare through real-world evidence. We bring together scientific expertise and real-world data to help sponsors make decisions and accelerate evidence generation to improve patient outcomes. In this role, you'll work closely with one sponsor, gaining deep knowledge of their therapies while leveraging IQVIA's global expertise. Overview: Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards, including but not limited to natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies. Skill sets of the Epidemiologist role are similarly required, with the expectation of more experience, able to operate strategically under limited supervision, well versed in current Epidemiology research methods, deep understanding of how RWE fits within drug development, regulatory, medical, safety and other functions. Responsibilities: Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE. Lead, design, and manage epidemiological, biomarker and/or data science projects. Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries). Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy. Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed. Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers. Support the effective communication of study/analysis results to support internal and external decisions. Coauthor abstracts and manuscripts for external dissemination of methodologic study results. Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities. Technical Expertise: Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes. o Ability to design studies independently, (i.e., ability to translate research questions to create study design). Subject Matter Expertise: Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questions. Lead the design and execution of post-marketing and observational safety studies to evaluate product risk profiles and inform regulatory and clinical decision-making. Contribute to engagements with regulatory authorities to provide scientific input, respond to safety-related inquiries, and ensure compliance with evolving regulatory requirements. Requirements: PhD in Epidemiology with a minimum of four (4) years of post-doctoral experience, preferably at a pharmaceutical company. Master's degree in Epidemiology plus 7-9 years of experience in lieu of PhD may be acceptable. Oncology Specific: expert knowledge and extensive experience (at least 2+ years leading studies) with cancer epi (solid tumor experience a plus), extensive experience with oncology EMR databases, extensive experience with conducting cancer epi studies. Pharmaco Epidemiology Specific: expert knowledge and extensive experience with pharmacoepi methods (i.e., signal detection and validation methods), expert understanding of regulatory requirements for safety reporting and analysis, RMPs, and PASS both US and global. Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development. Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases. A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred. Demonstrated ability to function with an increasing level of autonomy and to develop productive cross- functional collaborations in a matrix environment. Ability to manage priorities and performance targets. What's in it for you? Be part of a forward-thinking team that helps shape the next generation of evidence-based healthcare. Work hand-in-hand with one leading sponsor, gaining deep expertise in their therapies. Access IQVIA's global network who supports your growth. This is your chance to make an impact, while building a career that matters. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $110,500.00 - $276,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $69k-98k yearly est. Auto-Apply 14d ago
  • Therapeutic Strategy Director - Respiratory

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    The Respiratory space is a priority growth area for IQVIA with a growing number of business opportunities in the space that require a specific level of experience for early engagement and to create a winning strategy. We are looking for a Therapeutic Strategy Lead who is experienced in Respiratory global clinical trial development and can support customer engagement and responses to proposals. To be successful in this role, it is important to understand Respiratory disease clinical trial operations from Phase 1 to Phase 3 and apply operational strategies for seasonal indications.. The ideal candidate is an experienced, consultative leader responsible for driving early engagement and proposals aligned with client needs in collaboration with the business development and other stakeholders. TSL will serve as a therapeutic and operational strategy expert throughout the new business and program/project delivery lifecycle to increase IQVIAs therapeutic market share with early engagement and innovative strategic responses to proposals. This pivotal role represents and demonstrates IQVIA's credibility with clients, furthering the R&DS business by designing market-leading solutions to secure new projects. Drawing on dedicated proposal development, technical and scientific support, the TSL will be expected to lead cross-functional teams in designing such solutions and ensuring projects are set up to be successful from proposal development through to award. The TSL will take ownership of high-level client relationships for the specified engagements in close collaboration with the sales and account team, with ultimate responsibility for securing business, client satisfaction, project margin, and differentiating IQVIA. RESPONSIBILITIES Business Growth and Client Engagement: Leverage IQVIA medical, scientific, operational and data science experts to determine the optimal solution, project design and lead a cross-functional team in proposal development through to award Assigned to take ownership of developing client-centric solutions, designing both strategic and methodological approaches to ensure that IQVIA secures client projects Champion and advocate the CORE-powered solutions and include existing and new innovative solutions as applicable and appropriate through the sales process. This may include, but is not limited to, stand-alone programs and projects, requests for information (RFI), capabilities, and early engagement. Strategy Development: As a leader of the pre-award strategy team, the TSL is accountable and responsible for creation of innovative, effective, and compelling therapeutic and operational strategies that client differentiate IQVIA from its competitors. Work with key internal stakeholders and pre/post-award teams to analyse information and data that enables development of efficient and feasible delivery solutions. This may include, but is not limited to, protocol feasibility and risk management, assessment and management of the competitive landscape, optimal country and site distributions, site and patient recruitment strategies, monitoring and vendor strategies. Actively support Sales in the preparation and conduct of client and bid defense meetings e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys project strategy and critical win themes. Attend and present at client meetings, or bid defense meetings, as required, (based on the strategy for selling the opportunity). Strategy Translation and Post Award Support Translate the sold strategy to the delivery team and be an available resource for the delivery team when changes to strategy are required. Provide post award strategy guidance and support to delivery teams if in-flight studies require changes to strategy REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Remain up to date with knowledge and information that supports effectiveness as a Therapeutic Strategy Lead e.g. understanding IQVIA' services, tools and product offerings, status and trends in assigned TA(s), innovations and advances in clinical trial methodology, and business intelligence. Broad protocol and therapeutic knowledge results Comprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization. Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required Confident and capable in the use of technology, applications, and other media e.g. databases and internet to research new opportunities, maintain currency of therapeutic and operational knowledge, and competitive landscape. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences, advanced degree preferred, with extensive knowledge of Internal Medicine and 10+ years' global clinical research experience, including hands on Phase I operational delivery and/or drug development experience. Proven track record in operational delivery and/or drug development; or equivalent combination of education, training and experience. Must have extensive experience with Clinical Operations and Clinical Project Management. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $139,700.00 - $259,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $71k-101k yearly est. Auto-Apply 60d+ ago
  • Associate Director, Medical Writing

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development. As a strategic partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions This role reports to the Director of Medical Writing Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities Leads the Medical Writing contributions to assigned therapeutic area(s). Key accountabilities: Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinial Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed. Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission) The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines Forecasting, budgeting, resource planning and resource allocation. Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with intial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan). Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinial Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process. Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency. Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents. Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents. Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards. Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables. Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks. Responsible for continual improvement of in-house medical writing. Provides expert medical writing support to other CR&D and CSL groups where required In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance. Participant in bid defense, contract development, work alignment and / or operation meetings. Post-graduate qualifications (PhD or MD preferred) Experience A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organization. A minimum of 3 years in a supervisory role A comprehensive understanding of the clinical development process, including the documents that are required at each stage. A comprehensive understanding of medical writing processes, standards and issues. Demonstrated track record in cross-functional, multicultural and international clinical trial teams Excellent verbal, written and presentation skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation Prior experience with submissions in Common Technical Document (CTD) format. Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and template IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at ********************** We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. **********************/eoe As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. **********************/covid-19-vaccine-status
    $107k-172k yearly est. Auto-Apply 60d+ ago
  • Manager, IT Engineering

    Gilead Sciences, Inc. 4.5company rating

    Raleigh, NC job

    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** Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. **Summary:** This role sits within the global Gilead IT organization within the US Commercial Field Enablement IT team with the primary responsibility of supporting IT operations for Field Enablement applications. This role reports to the US Commercial IT Field Enablement lead. This role will support and liaise with a broad business team including Gilead Commercial Operations, Medical Affairs and Business Conduct. The role will also engage across IT teams who manage/support systems within the Capability ecosystem, i.e., integration touchpoints with tools such as Master Data Management platform and Commercial Analytics Hub as well as the broader IT team that enable the overall working experience for the business teams we support. This role would act as a liaison between CRM, Events and Account Management capability leads and the vendor MSP teams to manage and deliver on IT operations for field applications. This role would enable Next Gen CRM program by consolidating IT operations for field applications, quickly identifying and mitigating end user impacts and enabling focus on field experience with technology and IT change management. Some of the key activities that this role would lead include managing IT support operations teams, tracking and reporting on service requests and incidents, providing hands-on support and oversight for complex / priority tickets and escalations, participating in system testing and user acceptance testing, and managing deployment and hypercare. **Core Tasks, Responsibilities & Scope of Authority:** + Utilize ServiceNow to record and track incidents, service requests including report requests + Hands-on leadership and execution of IT support operations activities, working with MSP resources + Engage with offshore service teams and onshore business and IT partners daily to deliver support operations + Build and maintain a track of operational requests over time to advise leadership on trends with a key metric around first call resolution, warm transfers and minimizing field user time spent chasing IT support issues + Support field events such as National Sales Meeting with onsite presence when necessary + Proactive readiness and planning to support new product launches including onboarding field user groups + Support launch of new applications such as Veeva Align, Next Gen CRM, ongoing platform and application enhancements + Build and maintain relationships with individual field users and other support groups and product teams + Lead IT operations for the field teams in a secure and compliant manner, adhering to appropriate SOPs and work instructions **Additionally:** + Works closely with the respective Product Owners for Veeva / Vault CRM, Events Management, Align and other field applications to ensure end user experience for field applications remains positive + Leads operational reporting services delivered within the platform / application using Salesforce / Vault platform reporting, MyInsights / X-Pages **Basic Qualifications:** + Doctorate OR + Master's and 4+ years of relevant experience OR + Bachelor's and 6+ years of relevant experience OR **Preferred Qualifications:** + Strong techno-functional knowledge of Veeva Commercial Cloud, including but not limited to Align, Veeva / Vault CRM, Veeva Events Management as well as Salesforce platform, Vault platform + Strong problem-solving skills, experience in identifying and preventing issues from recurring, debugging and fixing code + Ability to prioritize incidents and service requests based on priority levels and knowledge of support escalation paths + High level of personal integrity consistent with Gilead's core values (Excellence, Accountability, Teamwork, Integrity and Inclusion) + Service-oriented, willingness to put in the extra yards to provide an outstanding experience to end users + Experience working in a multi-vendor scenario; vendor management experience is a plus + Strong communication skills to engage directly with business users, IT and vendor teams + Knowledge of ITIL framework and best practices + Knowledge of working with ServiceNow IT service management platform The salary range for this position is: $126,565.00 - $163,790.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
    $126.6k-163.8k yearly 41d ago
  • IQVIA - Per Diem - MedTech Travel Clinical Educator - Raleigh, NC

    Iqvia 4.7company rating

    Iqvia job in Raleigh, NC

    We welcome you to apply if interested! You will be asked to create an account, which takes less than one minute and requires only a username and password. The entire application takes no more than 5-7 minutes to complete. Job Description: Our RN Clinical Educators experience a unique opportunity to employ their clinical nursing expertise in a new way outside patient care, while continuing to collaborate with healthcare professionals and advocate for the well-being of patients through medical device technology. You will be responsible for training and educating Registered Nurses and Physicians on a new medical device primarily used in the Infusion, Vascular Access, Critical Care unit(s) setting. Your primary focus will be in-servicing and education only; no sales responsibilities, and no bedside care. A desire to expand your talents in clinical education. Per-diem position requiring travel and flexibility to work with your current schedule. Minimum availability of 2 weeks per month required. Travel regionally and nationally to support customer needs.. IQVIA takes the approach to helping customers drive healthcare forward in this challenging, fast-paced environment. We help customers accelerate results, improve patient outcomes, and unleash new opportunities. Responsibilities: Provide peer-to-peer education and in-servicing to nurses, physicians, and hospital staff to support medical device implementations Assess customer-specific education needs and collaborate with staff to deliver a positive educational experience Utilize clinical nursing expertise to answer questions and address concerns with the medical device Provide updates, reports, and valuable feedback to client during and after in-service assignments Job Requirements: RN Degree - Associates required, Bachelor's preferred Active and Unrestricted RN license required Infusion or Vascular Access experience of at least 3-5 years required Critical Care unit experience of at least 2 years is preferred Leadership experience (manager, educator, preceptor) can be helpful but is not required Must be comfortable with basic software programs Ability to travel locally, regionally, and nationally You will have a flexible schedule, an opportunity to travel, grow and expand into new opportunities while earning supplemental income and learning the medical device industry. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is $36-38 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $36-38 hourly Auto-Apply 45d ago
  • Patient Care Coordinator- Weekend Shift- Thurs-Sun

    Iqvia 4.7company rating

    Iqvia job in Raleigh, NC

    **Patient Care Coordinator** A Patient Care Coordinator facilitates daily scheduling, and operations support in-home clinical programs by serving as the liaison of communication between patients and network clinicians, as well as HCPs and HUB operations. **Job Responsibilities:** + Initiate case creation by uploading Service Request Forms to operating system. + Oversee the scheduling process from start to finish by scheduling and confirming appointments with patients and network clinicians. + Document case details in Customer Relationship Management (CRM) system. + Place outbound calls and text messages to patients and network clinicians. + Answer incoming calls, text messages, and email correspondence. + Provide product and technical support along with superior customer service. + Report Adverse Events per program guidelines + Follow up on missing information on program documentation **Schedule** Thursday, Friday, Saturday and Sundays 8am ET -6:30pm ET **Required Qualifications:** + Must be proficient with Microsoft Office, especially MS Teams, Excel, Word, and Outlook. + Customer service experience. + High School Diploma or equivalent. + Must reside in country where the job is posted. + Excellent time management skills and ability to multi-task and prioritize work. + Strong verbal, written and communication skills. + Ability to interact courteously and professionally with patients and clinical staff. + Strong organizational skills with attention to detail. + Ability to work independently and as a team player. + Able to work in a virtual team environment by being available and responsive during working hours + Employees must have a private workspace free of distraction to adhere to HIPAA compliance/guideline. **Preferred Qualifications:** + Related field experience in healthcare administration scheduling patients and healthcare providers (preferred). + Call center experience preferred. + Some college preferred. + Experience with Salesforce, the Customer Relationship Management System(preferred). \#LI-CES [#LI-DNP] Note: This role is not eligible for visa sponsorship. Candidates must have authorization to work in the US without the need for sponsorship. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $34k-49k yearly est. 9d ago
  • Patient Site Engagement Operations Specialist

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    Patient & Site Engagement (PSE) Operations Specialist (OS) services provide the PSE Managers with administrative support for the management, execution and timely delivery of tactics for patient and site-facing initiatives in support of a clinical trial. Interface with key Delivery Unit customers Trial Delivery Leaders (TDLs), Trial Delivery Managers (TDMs). Interface with key Global Clinical Operations (GCO) customers Local Trial Manager (LTM) and Site Manager (SM), suppliers, and other stakeholders involved in the development, management, and dissemination of patient and site-facing tactics. Responsibilities: Services rendered will adhere to applicable sponsor SOPs, WIs, policies, local regulatory requirements, etc. Comply with relevant time reporting systems, training requirements and developing therapeutic knowledge enough for role and responsibilities. Ensure accuracy and oversight of Scope of Work (SOW) to reflect all External Service Providers planned services and budgets. This includes forecasting and proactive management of PSE trial budgets and Purchase Orders. Keep the project plan updated in relation to timelines and budget based on the scope of work for delivery of the tools and tactics for a clinical trial. Drive execution of tactics and initiatives through management of service providers as required by business including: creative and content development, global translations, material production, technical development of apps, websites, and other technological tools to promote patient/caregiver and/or site engagement. Ensure compliance with sponsor policies by way of documenting Compliance review and approval of tools and tactics; maintain oversight for IRB/EC approvals, as needed. Ensure clear communications with all stakeholders throughout the process to ensure clearly defined expectations. Stakeholders include service providers, study and clinical teams, PSE team members, leadership, and compliance. Contribute to study meetings via facilitation, attending, and/or presenting at various meetings. Maintain deep understanding and use of sponsor finance and contracting systems. Support the coordination of congress / conference preparations and on-site logistics, as applicable Ensure development and delivery of presentations and workshop content at Global Investigator Meetings, Ad Hoc face-to-face meetings, and other similar meetings as needed Education and Experience Requirements: BA/BS or equivalent, preferably in a scientific or health-related discipline. Minimum of 3 years relevant experience in global patient recruitment and clinical trial execution with a pharmaceutical company, CRO, and/or healthcare facility/research site. Strong clinical project management experience preferred Expertise in the areas of drug development, clinical trial operations, and strategic planning. Previous experience in clinical trial operations including the execution of study outreach, patient compliance and support programs. Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects. Excellent time, priority, and self-management skills. Strong project management skills. Strong team orientation: demonstrates initiative to solve problems and improve efficiency and/or customer service. High degree of proficiency in Microsoft Excel, PowerPoint and Word. Microsoft Project. Good written and oral communication skills. Strong understanding of appropriate software and company systems. Periodic travel as required IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $62,800.00 - $157,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $62.8k-157.1k yearly Auto-Apply 60d+ ago
  • Associate Director, Intelligent Solutions Engineering

    Gilead Sciences, Inc. 4.5company rating

    Raleigh, NC job

    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 Summary** We are seeking an Associate Director of Intelligent Solutions Engineering to lead delivery teams and initiatives building AI-powered platforms and cloud applications that streamline clinical trial processes and accelerate medicine delivery to patients. In this hands-on technical leadership role, you will oversee the architecture and development of custom products that automate workflows, enable data-driven decisions, and extract insights from diverse data sources. You'll drive technical execution by working directly with engineers, data scientists, business users, and cross-functional stakeholders to deliver robust, scalable, and maintainable solutions. This role requires balancing innovative AI technologies with real-world application requirements, ensuring our platforms are both technically sound and usable while aligned with business objectives. **Key Responsibilities** + Lead technical strategy, roadmap, and architecture for scalable, cloud-native software solutions across onshore and offshore engineering teams. + Partner with data science teams and business stakeholders to identify priorities and modernize processes. + Communicate technical vision to align and influence cross-functional teams and senior stakeholders. + Architect and implement platforms that integrate, analyze, and visualize data using serverless, modern web technologies, and full-stack AWS deployments. + Serve as technical subject matter expert for AI solutions, including Generative AI applications, context engineering, document generation, and agentic workflows. + Drive end-to-end product development from inception through production deployment and maintenance. + Establish and enforce software engineering standards, design patterns, and architectural principles. + Implement automation-first DevOps practices and champion continuous improvement initiatives. + Oversee offshore vendor partnerships to ensure quality delivery and product sustainability. + Mentor engineering teams on AI-driven software development practices and establish best practices for code quality, testing, and documentation, including training on AI tooling and implementation. + Research and apply emerging AI technologies and innovative approaches to solve complex technical challenges. **Basic Qualifications** + BA/BS with at least 10 years of relevant experience, MA/MS/MBA with at least 8+ years of relevant experience, or PhD with at least 2 years of experience. + 4+ years of cross-functional technical project management or other relevant leadership experience in a business environment, including multiple years managing project teams. + Expert-level understanding of software engineering fundamentals including data structures, algorithms, complexity analysis, and system design principles. + Proven experience leading full SDLC implementations across multiple methodologies (Agile/Scrum, waterfall, hybrid) and product development lifecycles. + Advanced Python proficiency building production REST APIs and async systems; working knowledge of modern frontend frameworks (React preferred). + DevOps proficiency with CI/CD automation (GitHub Actions, Terraform), containerization (Docker), and cloud security best practices (IAM, secrets management, network security). + Production AWS expertise: serverless architectures (Lambda, ECS), storage solutions (S3, RDS, DynamoDB), and infrastructure-as-code (Terraform). + Data integration engineering including API development, middleware solutions, event-driven architectures, and automated data synchronization pipelines. + Generative AI expertise with LLMs, prompt engineering, and frameworks (LangChain). + Proficiency with AI-powered development tools (GitHub Copilot, Cursor, Claude) for accelerated code generation and refactoring. **Preferred Qualifications** + Experience working in or alongside clinical, regulatory, or real-world evidence (RWE) functions. + Familiarity with GxP, 21 CFR Part 11, and other relevant compliance frameworks. + Experience with AI/ML applications in healthcare, including model evaluation, validation frameworks, and integration of multimodal data sources. **What You'll Gain** You'll have the opportunity to shape technical strategy at the intersection of software architecture and AI, working on transformative projects that deliver real business impact. This role offers the chance to build strong cross-functional relationships while staying at the forefront of emerging AI technologies. You'll develop your ability to bridge technical and business contexts, lead high-performing teams, and drive meaningful results through a pragmatic, value-focused approach to innovation-all while maintaining the technical depth to contribute from architecture to code. The salary range for this position is: Bay Area: $195,670.00 - $253,220.00. Raleigh: $168,980.00 - $218,680.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
    $195.7k-253.2k yearly 6d ago
  • Scientist I

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    **We are seeking a Scientist 1 to join IQVIA's laboratory business at** **Durham, NC.** **The Specifica team at IQVIA is seeking an accomplished scientist to contribute significantly to the conception, execution, and communication of antibody discovery strategies in a highly collaborative environment. The successful candidate will develop and execute research strategies to advance the discovery and development of antibodies for IQVIA partners across the world. Key responsibilities include designing and executing in vitro display technologies for lead antibody identification and optimization. The candidate is also expected to generate internal and external collaborations to further program goals and drive antibody discovery programs within a multidisciplinary research group in a dynamic, fast-paced team setting.** **What You'll Be Doing:** **Implement novel selection strategies for discovery and screening of antibodies.** **Identify and solve technical problems independently; conceive and implement innovative research ideas.** **Provide project updates, analyses, and advice to partners and senior management.** **Ensure consistency and quality of technical reports.** **Engage with internal and external scientific leaders in collaborative research.** **Contribute scientific insights into projects across various therapeutic areas; recognized as an expert in the discovery and engineering of therapeutic molecules.** **What We Are Looking For:** **BS or MS degree in Biochemistry, Biochemical Engineering, or related disciplines with typically at least 1-2 years of experience.** **Expert in aseptic technique.** **Strong molecular biology skills (cloning, PCR, SDS-PAGE).** **Experience with flow cytometry.** **Team player with excellent organizational skills and ability to manage multiple projects simultaneously.** **Familiarity with sequence analysis tools** **The Knowledge, Skills and Abilities Needed for This Role:** **Hands-on experience with in vitro antibody discovery display technologies (e.g., phage, yeast, mammalian).** **Experience and knowledge in protein engineering and optimization, especially antibodies** **Ability to explore and develop new approaches to advance innovative in vitro discovery and screening technologies.** **What We Offer You:** **We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.** **To learn more about our benefits, visit ********************************** **If you're looking to unleash your potential, join Q2 Solutions, IQVIA's laboratory business, to help make the extraordinary possible!** IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $62,000.00 - $129,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $62k-129.1k yearly 5d ago
  • Market Development Specialist - 3205708 East

    Iqvia 4.7company rating

    Iqvia job in Raleigh, NC

    IQVIA, in partnership with our client, Sanofi, is looking for high performing Market Development Specialists (inside sales representatives) with a track record of success to join our team! Market Development Specialists (MDS) will work within the Right Audience Right Engagement AI Ecosystem (1RARE.Ai Ecosystem) to identify accounts that have a low volume or no currently treated patients that may be identifying patients at the beginning of their diagnosis journey, who are diagnosing patients who are not treated (DNT), or may have potential to manage patients that may be suitable candidates for a Sanofi therapy. MDS shall assist in validating leads provided by the 1RARE.Ai Ecosystem Next Best Action trigger program. MDS will send messages to those practices with the appropriate target profile and offer them educational materials regarding diagnosis and treatment OR may identify the key customers within the account and pass the lead to Sanofi FTE field team (Strategic Account team or Community Development team). MDS will facilitate in-service calls with appropriate healthcare professionals (HCPs) for Sanofi team when appropriate. **MDS Goals** **:** + Validate leads from the Next Best Action platform. Validation may indicate that the account has potential patients, patients currently diagnosed and awaiting treatment, or referral to a COE. + Enhance the inputs for Sanofi's Adaptive Audience Platform, improving the accuracy of future lead generation, targeting and digital marketing campaigns. + Provide high value HCP leads to field sales of those who have not previously treated appropriate patients and would like additional follow up regarding disease education and Sanofi products. + Deliver Sanofi approved disease state information to HCPs to help facilitate the proper identification and diagnosis of specific rare diseases. + Identify and validate potential new HCP targets and segments within practices that may be diagnosing and potentially managing appropriate rare disease patients. + Update practice information, referral networks, and audience segmentation for other sales and marketing efforts including digital marketing, email, direct mail, or telephone outreach. + Build relationships with key customers and deliver appropriate product and patient access information in a compliant manner. + Demonstrate in-depth disease-state knowledge and familiarity with Sanofi products. + Be able to set and own a plan, and adapt the plan as needed in order to drive initiatives to completion in order to meet position goals. + Communicate frequently with Sanofi Field Sales Team and other cross-functional counterparts such as Digital Marketing + Have a mindset of continuous learning and development. + Meets all administrative responsibilities within timelines and company guidelines; + Understand the legal and compliance environment and drive collaboration with the Legal and Compliance Department + **Bachelor's Degree required** with a preference toward a clinical or life sciences degree. + Nursing or other clinical degree acceptable + **Minimum of 2 years of Inside Sales / Virtual Account Management experience** to **Healthcare Professionals** (pharmaceutical, biotech, device or healthcare industry) required. + **Digital Experience preferred** or aptitude to comprehend digital promotion required. + Inside / Virtual Sales Experience in specialty or complex disorders a plus. + Proven track record of exceeding program metrics + Proven **ability to communicate clinical information with HCPs / HCP office staff** using approved marketing materials. + **Demonstrated account management** and superior communication skills focused on **providing a high level of customer service** . **REQUIRED KNOWLEDGE AND ABILITIES** **:** + Must be able to engage customers in a persuasive and compliant manner virtually. + Proven ability to work collaboratively with a cross-functional team to execute against business goals. + Strong cross-functional teamwork skills. + Strong relationship building skills and the ability to identify key decision makers to closely monitor patient symptoms and identification. + Accountable for deep understanding of disease state and products clinical efficacy + Analyze Lead trends and identify high-value leads to alert field sales team. + Ability to learn quickly and apply disease state knowledge to recognize high-value leads + Must be self-motivated with strong desire to achieve success. + Excellent interpersonal, verbal, and written communication skills + Ability to develop and sustain customer relationships. + Ability to analyze data, recognize patterns, and use a data-driven approach to identify high value leads. + Extensive knowledge of compliance requirements for interacting with healthcare providers + High achievement, drive, self-motivation, and integrity. \#LI-CES IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is $75,000 to $100,000 annually. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $75k-100k yearly 29d ago
  • Site EHS Manager

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    RESPONSIBILITIES: Assess site EHS programs for prioritized risks and gaps. Assist Global Biosafety Officer and Vaccines Lab Director in evaluation of biosafety risk assessments and new protocols. Lead EHS governance elements and practices required to operate under ISO 14001 and ISO 45001 certification. Ensure corrective actions are implemented and documented in response to corporate, sponsor and site audits and reviews. Maintain site compliance calendar, ensure all recurring compliance actions are assigned and verify timely completion. Produce, implement, monitor, update and actively promote EH&S policies/procedures and safe systems of work at the site. Identify training needs and ensure the delivery of appropriate training to management, staff and site EH&S Representatives to ensure compliance with applicable legislation. Assist with the production, design, and implementation of EHS risk management. Manage the measurement and control of EHS performance. Coordinate EHS department representatives and lead monthly EHS committee meetings. Act as site Chemical Hygiene Officer Act as site Biosafety Officer and lead Institutional Biosafety Committee Maintain a current knowledge to ensure the site is compliant with applicable EHS regulations and best practices related to EHS. Work with site management to ensure appropriate corrective actions are taken on health, safety and environmental hazards or potential hazards. Assist investigation teams after recordable incidents to conduct RCAs and develop CAPAs. Ensure site regulatory compliance and reporting with corresponding agencies. Assist in ensuring compliance to SOPs in Q Squared Solutions EHS Management System or their more stringent regional equivalents.. Provide coaching and support to the site sustainability champion to assist with Corporate Sustainability goals and implementation. MINIMUM REQUIRED EDUCATION AND EXPERIENCE: Bachelor's Degree in Technical or Safety related field required. Training or experience with biosafety in laboratory environments. 3-5 years' relevant experience. Working regulatory knowledge and experience interfacing with regulatory agencies. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES: Professional certification strongly preferred, e.g. Certified Safety Professional and/or Certified Industrial Hygienist (or equivalent certification in country or jurisdiction) or eligible for certification. Thorough knowledge of EHS legislation within the country. Good knowledge of the relevant local EHS regulations, international EHS management systems (e.g. ISO 14001 and OHSAS 18001 preferred) Good knowledge of corporate standards and policies. Equivalent combination of education, training and experience. Exceptional organization and analytical skills. Excellent interpersonal skills that enable effective interaction/communication with management at many levels. Effective leadership abilities. Comfortable presenting and training in large and small groups (training/presentation, communication with site management). Excellent influencing skills. Good technical writing skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. ************************************** We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. *************************************** As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. ***********************************************************
    $75k-95k yearly est. Auto-Apply 60d+ ago
  • Senior Network Systems Engineer

    Iqvia 4.7company rating

    Iqvia job in Durham, NC

    As a Senior Network Engineer, you participate in the implementation, and support of complex hybrid network infrastructures across global environments. This role demands a strategic mindset and deep technical expertise to deliver high-impact projects that align with enterprise security standards, performance optimization goals, and scalability requirements. You will help define and drive the evolution of IQVIA's global network ecosystem transforming it into a programmable, automated, and platform-agnostic infrastructure. You will be responsible for planning, deploying, documenting, and maintaining both new (SoNIC, Cumulus) and existing (Cisco) network architectures in highly dynamic and secure environments. A strong understanding of Linux-based systems, network programmability, and infrastructure-as-code principles will be essential as you help build a globally consistent and scalable network foundation. Key Responsibilities Support SDN solutions, focusing on Cisco ACI across multiple data centers. Integrate AI-driven network monitoring and predictive analytics. Serve as a senior technical advisor to Tier 2 engineers, providing mentorship and consultation. Provide expert-level support during major incidents, including root cause analysis and resolution planning. Translate Global Network Support (GNS) standards into actionable low-level designs, including hardware quoting and documentation. Partner with Mergers & Acquisitions (M&A) and Global Real Estate teams to integrate new acquisitions into IQVIA's network standards Lead network buildouts, office restack implementations, and refresh initiatives Lead strategic network projects across departments, regions, and time zones. Automate implementations across platforms: Generate and deploy F5 configurations, Palo Alto firewall rules, and Cisco ACI policies through Ansible, Python, Terraform, and/or API-driven automation. Implement CI/CD pipelines to validate and roll out network and security changes safely and repeatably. Implement and support network segmentation strategies for zero-trust architectures and compliance mandates. Oversee incident response and escalation workflows, ensuring timely resolution and stakeholder communication. Maintain DNS (BIND), IPAM, and domain name services across enterprise environments with automation-first principles. Support branch office automation initiatives using Cisco DNA Center and other vendor platforms. Required Skills and Expertise Extensive experience with software-defined networking technologies (Cisco ACI, SoNIC, Cumulus Linux, or equivalent), including the ability to: Deploy Cisco ACI fabric including spine-leaf topology, APIC controllers, and policy-based configurations. Configure multi-pod and multi-site Cisco ACI environments for scalability and redundancy. Implement L4-L7 service insertion using service graphs and contracts. In-depth understanding of Linux networking, kernel-based switching, and open-source routing stacks (FRR, BIRD, and Quagga). Proven experience developing and deploying infrastructure-as-code for network and security platforms (Ansible, Terraform, Git, YAML, JSON). Experience automating configurations and policy enforcement across: Cisco ACI and DNA Center F5 load balancers (iControl REST, AS3 templates) Palo Alto firewalls and Panorama (REST and XML APIs) Proficiency in routing and overlay technologies (BGP, EIGRP, VXLAN/EVPN, OSPF, etc) and switching. Experience in SDWAN deployments and support. Understanding of network segmentation, zero-trust access, and security frameworks. Familiarity with cloud networking platforms including AWS Direct Connect, Azure ExpressRoute, and hybrid/on-prem cloud solutions. Experience with packet capture analysis, network monitoring, performance tuning, and capacity planning. Strong organizational and communication skills, with the ability to manage multiple priorities and stakeholders. Ability to foster effective working relationships across global teams and drive consensus in complex environments. Qualifications Bachelor's degree in Computer Science, Electrical/Computer Engineering, Information Systems, or equivalent practical experience. Minimum of 7 years of progressive experience in network engineering, architecture, and support. Minimum of 3 years hands-on experience with software-defined networking, Linux, and infrastructure as code methodologies. Certifications: Cisco (CCNA/P), cross-platform automation and/or Linux certifications preferred but not required IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $76,200.00 - $190,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $76.2k-190.3k yearly Auto-Apply 34d ago

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