Parexel International jobs

**Join Our Medical Communications Team at Parexel as a Senior Program Specialist (Publications)** Are you a seasoned project manager or account manager with experience in medical communications-particularly in publications? We're seeking a **Senior Program Specialist** to lead the execution of complex, multidisciplinary publication programs while driving excellence across cross-functional teams. This is a full-time, remote position that may require occasional travel. This is a full time remote position. Candidates need to work out of Canada or the continental United States. **What You'll Do** As a Senior Program Specialist, functioning as a program/project manager you will: + **Lead and facilitate program/project kick-off meetings** , establishing clear roles, responsibilities, and expectations across internal teams and external stakeholders. + **Develop and manage comprehensive project plans** , delivery schedules, and tracking systems to ensure timely, high-quality execution. + **Maintain proactive communication** with clients, faculty, and internal teams, serving as the key point of contact for project status updates and issue resolution. + **Monitor budgets, timelines, and deliverables** , identifying risks and resolving issues promptly to keep projects on track and within scope. + **Collaborate cross-functionally** to define project scope, staffing requirements, and implementation strategies, raising concerns and adjusting plans as needed. + **Support proposal development and budgeting processes** , contributing to program specifications, cost assessments, and implementation planning. + **Champion best practices** in communication, process efficiency, and team collaboration, continuously identifying opportunities for improvement and innovation. + **Ensure alignment with strategic goals and product messaging** , working closely with Account Managers/Directors and functional teams to deliver impactful solutions. **What You Bring** + Must have 5+ years experience in medical communications project management, (Publications). + Proven ability to lead teams and deliver projects on time and within budget. + Strong organizational, negotiation, and interpersonal communication skills. + Advanced proficiency in Microsoft Word, PowerPoint, Excel, Outlook, and database tools. + iEnvision experience is required. + Familiarity with publication guidelines (e.g. ICMJE). + Bachelor's degree required; Master's preferred in Business or Life Sciences. **Why You'll Love Working Here** + Be part of a collaborative and innovative team. + Work on impactful healthcare and scientific programs. + Enjoy a flexible work environment with growth opportunities. **Ready to make a difference?** Apply today and bring your expertise to a team that values excellence, innovation, and collaboration. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We depend on agile and committed members who grasp the significance and impact of their roles in Pfizer's mission. Patients require colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts will ensure that patients and physicians have timely access to the medicines they need. What You Will Achieve You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations. Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines etc. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. In this role, you will: Execute production activities using knowledge of process equipment, systems, and manufacturing operations. Participate in operational qualification training and assist the Team Lead as needed. Ensure all activities comply with Company policies, standard operating procedures, Pfizer Values, and global regulatory and environmental guidelines. Work in a structured environment using established procedures. Ensure work is regularly reviewed for technical judgment, completeness, and accuracy. Assist in troubleshooting, technology transfer, and start-up activities. Applies established analytical tools to reduce cycle times and optimize production scheduling. Oversee technical documentation for production and process approvals, ensuring compliance with Current Good Manufacturing Practices, and manage process activities by adhering to Standard Operating Procedures. Assists production teams with batch paperwork and performs system transactions. Monitors and communicates production metrics. Ensures compliance with all government and company regulatory requirements. Verifies batch reconciliation and investigates all discrepancies immediately. Prepares Manufacturing Discrepancy Reports, as necessary, and escalates issues requiring Management Investigation Reports (MIRs) regarding deviations in process tasks or equipment set-up and testing. Partners with the Quality, Technology and Operations personnel to investigate Manufacturing Incidents applying tools as CAPA to eliminate root cause in investigating. Participates in continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time. Able to handle routine problems independently. Works with cross-functional experts in solving problems. Reviews, updates, and revises SOP's. Here Is What You Need (Minimum Requirements): Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience Knowledge of process equipment and manufacturing operations Ability to follow standard operating procedures and regulatory guidelines Basic understanding of Current Good Manufacturing Practices Strong organizational skills to manage project tasks and meet deadlines Technical documentation skills for production and process approvals Bonus Points If You Have (Preferred Requirements): Experience within the pharmaceutical industry Familiarity with Six Sigma or other operational excellence programs Proficiency in troubleshooting and technology transfer activities Strong analytical skills for process monitoring and data analysis Excellent communication skills for presenting data in project team meetings Strong problem-solving skills PHYSICAL/MENTAL REQUIREMENTS Ability to gown aseptically, stand for long periods of time, to lift 50 lbs. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to shift work schedule to accommodate production needs. Occasional evening or weekend work. Work Location Assignment: On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site. Work Location Assignment: On Premise The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Manufacturing

We are currently seeking a full-time, office-based Call Center Assistant to join our Phase 1 Unit Call Center team. This position will be part of a team focused on recruiting participants for our research studies and contribute to the company's success. If you enjoy a fast paced, dynamic work environment, and want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities * Handle inbound and outbound calls to schedule participants with a screening appointment utilizing our participants database; * Utilize a phone screener to determine whether participants meet the required criteria for our available research studies. Hours: M-F, 8:00 AM - 6:30 PM (Shifts can vary during those hours) and rotating Saturdays from (9:00am - 1:00pm required) Qualifications * High school diploma; * Experience in the medical industry preferred; * Experience in a call center environment preferred; and * Ability to work a first and second shift schedule between the hours of 8:00am and 6:30pm with rotating Saturday's and extended hours. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Our imaging services are growing rapidly, and we are currently seeking a full-time, office-based Radiologist to join our team. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities * Completing source documents accurately and promptly, according to the specific protocol requirements and Medpace's SOP * Blinded independent central review of radiology examinations according to clinical study protocol endpoints as specified in study protocol, charter and according to GCP and standard Medpace SOPs * Reviewing protocols, Image Review Charters and associated clinical and technical study documents as required * Participating in training and subsequently demonstrating competency in the operation of independent central radiological review of imaging for clinical trials * Participate in oversight of assignments, training, and management of central reader * Participating in InterReader and InterReader variability assessments * Participating in sponsor site visits and audits as requested * Collaborating with management to resolve technical/radiological/study concerns and problems. * Participating in the development, review and evaluation of SOPs and study specific procedures. * Other duties as assigned Qualifications * Must have an M.D. and current medical licensure; * Experience with most medical imaging modalities and expertise interpreting one or more imaging modality and therapeutic application * Experience with various medical image analysis and viewing software (PACS) and use for quantitative image assessments * Experience working with computer software including Word, Excel, Access and Project preferred * Knowledge of radiological disease response criteria such as RECIST 1.1 preferred * Board Eligibility in Radiology or equivalent training demonstrating competency Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Join Our Medical Communications Team at Parexel as a Senior Program Specialist Are you a seasoned project manager or account manager with experience in medical communications-particularly in publications? We're seeking a Senior Program Specialist to lead the execution of complex, multidisciplinary publication programs while driving excellence across cross-functional teams. This is a full-time, remote position that may require occasional travel. This is a full time remote position. Candidates need to work out of Canada or the continental United States. What You'll Do As a Senior Program Specialist, functioning as a program/project manager you will: Lead and facilitate program/project kick-off meetings, establishing clear roles, responsibilities, and expectations across internal teams and external stakeholders. Develop and manage comprehensive project plans, delivery schedules, and tracking systems to ensure timely, high-quality execution. Maintain proactive communication with clients, faculty, and internal teams, serving as the key point of contact for project status updates and issue resolution. Monitor budgets, timelines, and deliverables, identifying risks and resolving issues promptly to keep projects on track and within scope. Collaborate cross-functionally to define project scope, staffing requirements, and implementation strategies, raising concerns and adjusting plans as needed. Support proposal development and budgeting processes, contributing to program specifications, cost assessments, and implementation planning. Champion best practices in communication, process efficiency, and team collaboration, continuously identifying opportunities for improvement and innovation. Ensure alignment with strategic goals and product messaging, working closely with Account Managers/Directors and functional teams to deliver impactful solutions. What You Bring Must have 5+ years experience in medical communications project management, (Publications). Proven ability to lead teams and deliver projects on time and within budget. Strong organizational, negotiation, and interpersonal communication skills. Advanced proficiency in Microsoft Word, PowerPoint, Excel, Outlook, and database tools. iEnvision experience is required. Familiarity with publication guidelines (e.g. ICMJE). Bachelor's degree required; Master's preferred in Business or Life Sciences. Why You'll Love Working Here Be part of a collaborative and innovative team. Work on impactful healthcare and scientific programs. Enjoy a flexible work environment with growth opportunities. Ready to make a difference? Apply today and bring your expertise to a team that values excellence, innovation, and collaboration. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

We are looking to fill a **Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Description** Support of routine bioanalytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation. Other potential opportunities include method development/optimization, workflow optimization, and template development. **Responsibilities** + Support of high-throughput, pre-formulation, pre-qualification, robustness, or admixture testing + Results processing and documentation by following appropriate methods / protocols / procedures + Sample management and monitoring of controlled temperature units. + Following all appropriate laboratory safety and hygiene procedures **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in analytical chemistry or biologics testing lab + MS (1-2 yrs.) of relevant experience in analytical chemistry or biologics testing lab **Required Skills and Experience** + Must have separations experience for large molecules or plate-based assay experience. + Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques: + Liquid Chromatography (HPLC / UPLC) + Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC) + Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF) + ELISA (HCP, proA) and binding potency assay + qPCR and basic molecular biology techniques (gel electrophoresis, etc.) + High-throughput liquid handling system, e.g., Tecan, Bravo, etc. + Basic instrumentation troubleshooting + **Ability and willingness to train in molecular biology and immunoassay testing** + **Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)** **Desired Skills and Experience** + Familiarity with compendial testing such as UV 280, pH, and Physical Observations + **Ability to follow complicated scientific protocols / procedures** + Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases) + Good documentation practices & utilization in electronic lab notebooks (ELN) + Analytical software such as Empower. + Knowledge of Laboratory Information Management Systems (LIMS) + Sample submission & sample management + Monitoring of controlled temperature units + Experience with BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Reviewer to join our Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Responsibilities * Comprehensive manual review of clinical data collected in trials; * Development of clinical review guidelines for specific therapeutic areas; * Interface with Data Management team to assure query resolution. * Seeking specialization in following therapeutic areas: * Oncology * Infectious Disease * Cardiology * Endocrine * Hematology * Stable schedule with no weekends, no work on Medpace holidays, and flexible work schedule* Qualifications * Bachelor's of Science in Nursing and RN required, * At least 3-4 years of nursing experience * 1-2 years of specific therapeutic experience * General knowledge of clinical trial processes and/or experience working with clinical data; and * Familiarity with Microsoft Excel preferred. TRAVEL: None Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance. This role also contributes to site selection, provides local intelligence, ensures site support, resolves issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks. **Key Accountabilities** : **Site start-up and activation** + Deploys client site strategies by qualifying and activating assigned sites + Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide site qualification output for site selection + Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision + Maintains a knowledge of assigned protocols + Conducts study start-up activities at the site level including but not limited to Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation + Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation + Supports country specific ICF review and deployment up to Site Activation + Ensures follow up activities' completion post Site qualification visit and SIV to ensure site readiness for First Subject First Visit (FSFV) + Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV + Responsible for relationship building and operational quality of the site + Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners + Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.) + Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study + Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for enrollment delivery during study conduct + Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country / local registry up to Site Activation **Intelligence gathering** + Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics + Provides support to study management to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies **Study conduct and close-out** + Reviews Site Reports and related issues + Assures quality and consistency in the delivery of monitoring + Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management **Compliance with Parexel standards** + Complies with required training curriculum + Completes timesheets accurately as required + Submits expense reports as required + Updates CV as required + Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements **Skills:** + Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements + Must demonstrate good computer skills and be able to embrace new technologies + Good communication, presentation, and interpersonal skills + Ability to manage required travel + Demonstrated networking and relationship building skills + Demonstrated ability to manage cross functional relationships + Ability to communicate effectively and appropriately with internal & external stakeholders + Ability to adapt to changing technologies and processes + Knowledge of country requirements for GCP that may be different to those of client procedures + Effectively overcoming barriers encountered during the implementation of new processes and systems + Identifies and builds effective relationships with investigator site staff and other stakeholders + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization + Able to manage issues that are escalated by site staff in a way that meets the needs of both the client and the site staff **Knowledge and Experience** : + Demonstrated experience in site management with prior experience as a CRA in Oncology + Demonstrated experience in start-up activities through site activation + Demonstrated experience in conduct and close out activities + Demonstrated knowledge of quality and regulatory requirements in applicable countries **Education:** + Bachelor's degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years' experience) + Proficiency in local language preferred. English is required \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Our corporate activities are growing rapidly, and we are currently seeking a full-time, Phlebotomist to join our Clinical Pharmacology Unit team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Schedule: 3PM-11:30PM with varying start and end times. Shift Differential available! Responsibilities * Assist with study participant screening, admission, orientation, conduct, and discharge; * Demonstrate technical skills in phlebotomy, laboratory specimen collection, electrocardiogram placement, vital signs, and other protocol-related procedures; * Assess, document, and notify appropriate project team members of study participant adverse events in timely manner; * Assist other clinical staff with study-related duties (e.g., laboratory draws, electronic data capture entry, queries, follow-up appointments); and * May coordinate studies including working with the research team on development of overall study processes in accordance with the protocol, obtain informed consent, conduct study visits, maintain accurate investigational drug accountability when dispensing study drug. Qualifications * High school diploma and at least one year of phlebotomy experience; * Graduate of a medical assistant or phlebotomy program preferred. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

The MABI team works directly with management and leadership across the organization to conceptualize, document, and produce impactful solutions to help answer key business questions and communicate insights. This is a highly impactful team which consistently has direct impacts on the bottom line of our business. The Systems Optimization Internship position within this team provides a unique opportunity for students who are currently pursuing a business, business technology, computer information systems, or analytics like degree to get hands on experience working directly with stakeholders to turn business needs into system solutions that impact employees across the company. Responsibilities * Collaborate with stakeholders to understand business needs and deliver meaningful analytics; * Work with stakeholders to document and gather requirements for enhancements and bugs within supported software systems; * Create, review, and carry out functional test script plans for software bugs and enhancements; * Gather, review and input data from a wide variety of sources across the organization; * Assist in the design and documentation of business processes and reporting structures; * Learn core business and operational concepts through hands-on experience in process improvement, development of critical thinking, and presentation skills; * Work under close supervision of other team members and Sr. analysts. Skills & Abilities: * Interest in the design and documentation of business processes and reporting structures; * Aptitude for quickly learning new technology and software, with ability to apply its use; * Familiarity with common programming languages (SQL, Python, Java, C#) preferred; * Interest in Microsoft Power Platform (Power Automate, Power Apps, Power BI) preferred; * Exceptional customer focus (internal business customers); * Solid communication skills, with ability and confidence to present to an audience of varied leadership levels; * Ability to work independently and as a member of a high performing cross-functional team; * Willingness to learn, be mentored, and improve. Qualifications * Ability to work office-based in Cincinnati, OH (part-time or full-time) from January-April 2026 (opportunity to stay on for multiple rotations is determined by performance and team need); * Pursuing a Bachelor's or Master's degree in Business, Life Science, Computer Science, or other related degree with emphasis (minor or experience) in Analytics. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Medpace Clinical Pharmacology, a 96-bed facility specializing in early phase clinical trials, is led by a team of highly trained clinical researchers who are experts in the design, implementation, and analysis of Phase I - IIa studies. The Phase I Unit, functionally integrated with Medpace, a large global Clinical Research Organization, conducts studies and collaborates with the best therapeutic minds in the industry to bring promising drug compounds to the market. Responsibilities * Provide day-to-day departmental/project support activities, such as maintenance of project-related files and faxing documents to sites; * Triage and support clinical site staff with questions related to reports, resupply requests, or general study related question; * Data entry into Medpace proprietary systems and Excel spreadsheets; * Coordinate and provide minutes for department/project meetings or conference calls; * Maintain spreadsheets and compile reports; and * Perform other tasks as needed. Qualifications * Bachelor's degree in science or a health-related field; * Excellent oral and written communication skills. * Broad knowledge of medical terminology and clinical research methodology. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

**Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.** Job Purpose: The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality. This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company's objectives. Key Accountabilities: Oversight of activities - Write and edit clinical regulatory documents for clarity, and accuracy according to Sponsor standards. - Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives. - Provide writing support for a wide range of documents, including but not limited to investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. - Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices. Collaborative relationships - Collaborates effectively with lead writers and project teams to develop and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines. Compliance with Parexel standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - At least 4 years of writing experience in the pharmaceutical industry - Experience with a variety of regulatory and clinical documents - Experience in a matrix team environment - Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Knowledge and Experience: - Ability to write and edit complex material to ensure accuracy and clarity, - Excellent written and oral communication skills and demonstrated problem-solving abilities - Ability to handle multiple projects and short timelines - Ability to work cooperatively with colleagues in a wide range of disciplines Education: - BA/BS or higher \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Feasibility & Proposals department is looking for qualified analysts to join our Informatics Team in our Cincinnati office. The informatics team utilizes informatics principles and techniques to architect, mine, analyze, and visualize clinical trial data to inform study design choices for pharmaceutical development. Informatics Analysts create compelling visualizations and recruitment models to support proposal feasibility strategies and ad hoc analytical projects. The Informatics Team is a highly collaborative team with members in both the Cincinnati and London offices. This team supports clinical operation, medical, and feasibility teams with advanced data query and analysis. The Informatics Team also works side-by-side business analytics and software engineering to architecture innovative data storage and access solutions for optimal data utilization strategies. If you are an individual with a background or interest in data science, statistics or epidemiology, please review the following career opportunity. Responsibilities * Evaluate data needs for assigned projects and make recommendations on strategic approach specific to the study design and opportunity specifics; * Perform comprehensive review of data sources to deliver high quality informatics data and analysis to teams; * Work alongside global feasibility leads to contribute to proposal strategy for site and country selection based on available data; * Translate the results of feasibility research and analysis into compelling data visualizations which illustrate the overall feasibility strategy including enrollment modeling; * Design and implement database architecture plans and perform custom queries for methodological and clinical data sources; * Perform development and review of proposal text; * Assist project teams with preparation for bid defense meetings; and * Support departmental process improvement initiatives. Qualifications * Bachelor's, or Master's degree in informatics, computer science/engineering, biomedical engineering, health information, statistics, or related field; * Analytical thinker with great attention to detail; * Ability to prioritize multiple projects and tasks within tight timelines; * Excellent written and verbal communication skills; * 1-2 years of clinical research experience is preferred; and * Computer programming experience for data queries, database structure, and/or statistical analysis (preferred language: R) Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

We are looking to fill a **Scientist 3 - Analytical Chemist** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Responsibilities** + General understanding of analytical method development and method validation + Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques + General knowledge of separations science + Experience with Empower chromatographic software and with analysis of drug formulations + Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis + Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems **Required Skills** + Strong computer, scientific, and organizational skills + Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation + Excellent communication (oral and written) and attention to detail + Proficient in written and spoken English, is required **Desired Skills and Experience** + Empower software + Analysis of drug products + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude **Qualifications** + BS degree and 3-5 years of relevant experience, or + MS degree with at least 1-2 years relevant experience **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology, Inflammation or CMR preferred** The Study Physician (SP) is a critical global role that is created to fulfill aspirations of the client Medicine Excellence to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. SP work towards transforming client into a highly competitive performance organization by living target behaviors and AAI principles. **Accountabilities** + Responsibility for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Timely preparation of high medical quality CTP, which supports to avoid CTP amendments. + Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Timely provision of medically relevant critical data/process, related risks, and its mitigation/ monitoring strategies to the trial team. + Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsibility for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + High quality and timely medical contribution to trial CQMP (and its amendments). + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Take medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data Ongoing medical review with transparent documentation of the activity, related findings, and its resolution. + Timely and ongoing monitoring of medical data to avoid the need for late-stage reviews and queries and ensure the adherence to trial timelines medical oversight by using advanced technologies and systems. Proactively address/ communicate clinical quality issues in a collaborative environment. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan , laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc.. + Responsibility for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc... Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report. + Timely contribution to the core study documents. Availability of high-quality study documents from medical perspective + Contribution to the medical content of responses to questions from regulators and Ethic Committees/IRBs. Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Response to medical queries from Investigators, CROs and/or Sponsor team representatives and contribution to maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. Support of Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective. + Medical questions are responded in a timely manner and with state-of-the-art medical expertise. Delivery of high-quality data from medical perspective **Minimum Education/Degree Requirements** + Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of 4 years of active clinical practice experience; specialization in internal medicine or general practice is desirable. **Required Capabilities (Skills, Experience, Competencies)** + Excellent communication skills and team spirit. + Pronounced analytical skills and systematic and well-structured working style. Pronounced presentation and training skills. + Capability to work proactively and with team spirit in an international environment and team. + Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment. + Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Operations team in Denmark (candidates can be based anywhere in Denmark). This position will work on a Nordic team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. If you are looking for a stable, consistently, rapidly, developing CRO, Medpace is a great place for you! We are currently seeking full-time, home or office-based Clinical Research Associates to join our energetic Clinical Monitoring team in the Denmark. We offer an exciting career where you can grow further, using your current and and previous expertise. Responsibilities * Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas; * Perform source document verification and case report form review; * Perform regulatory document review; * Conduct study drug inventory; * Perform adverse event and serious adverse event reporting and follow-up; and * Assess patient recruitment and retention. Qualifications * Bachelor of Science in health-related field; * Proven CRA experience of at least 1.5 years independent monitoring experience * Broad knowledge of medical terminology and clinical patient management; * Basic knowledge of drug therapy techniques and clinical research methodologies; * Fluency in local language and excellent English are required. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 50+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks * Flexible work environment * Competitive compensation and benefits package * Competitive PTO packages * Structured career paths with opportunities for professional growth * Company-sponsored employee appreciation events * Employee health and wellness initiatives Awards * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary Serve as a scientist in the conduct of assigned nonclinical or clinical research studies of basic to moderate complexity, to include study management, interpretation, and reporting of study data, and assuring the regulatory compliance of these projects. ESSENTIAL DUTIES AND RESPONSIBILITIES: Efficiently peliorm and document all procedures, materials, and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.) Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data. Assist with the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues, with minimal oversight. Effectively develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area, with minimal oversight. Develop critical thinking, troubleshooting, and lime management skills aligned with needs of operational areas. Demonstrate effective communication skills through informal discussions with peers, supervisor, and team. Able to recognize method and/or data issues and communicate them to management to minimize study impact independently. Independently prepare summary of method development data. Execute review and approval of data for final scientific/technical decisions within a single operational area, with minimal oversight. Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software, with minimal oversight. Responsible for writing and preparing study plans/protocols/amendments/reports independently. Participate in sponsor visits/tours, with minimal oversight. Independently function as liaison, maintaining timely and frequent communication between CRL and sponsor/client/SD. Independently ensure scientific integrity of studies. Independently function as a Principal Investigator, Individual Scientist, or Project Scientist as assigned. Write, review, and approve deviations, with minimal oversight. ull understanding of regulatory and GLP requirements, industry standards, and company SOPs within one operational area. Effectively manage a small portfolio of projects, including method development and validation studies while ensuring timelines are met in a single operational area, with minimal oversight. Provide support to staff members as required by operational areas, as needed. Actively participate in internal process improvements, presentations and harmonization efforts. Attend scientific meetings, conferences, and training courses to enhance job and professional skills. Perform all other related duties as assigned. Job Qualifications Education: Bachelor's degree (B.A./B.S.) or equivalent in a scientific related discipline, required. Related Master's degree (M.A. / M.S.) Ph.D. / D.V.M.) preferred. Experience: Minimum of 9 to 12 years related experience in the contract research, academic, or pharmaceutical industry. Practical laboratory experience conducting ELISAs and multiplex assays preferred Hands-on experience with spectrophotometers, Bio-Plexes, and flow cytometers preferred An equivalent combination of education and experience may be accepted as a satisfactory substitute for the substitute for the specific education and experience listed above. Certification / Licensure: N/A. Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work a meet deadline. Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and with standard laboratory calculations. Physical Demands: Must be able to lift, move manipulate and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and / or supplies. Must be able to perform procedures, standing or sitting for longer periods of time, using appropriate instrument reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards. Must be able to frequently hold and manipulate work materials while utilizing fine motor skills. Must be able to regularly provide information to and receive information from/through various technologies, media sources, and contacts. Must be able to accurately exchange information in these situations. Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. Move about inside the work area to access to file cabinets, office machinery, etc. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus. Work Environment: General Office and lab working conditions, the noise level in the work environment is usually quiet. While performing the duties of this job the employee is regularly required to wear protective clothing (i.e. goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, and work with biohazards. The employee may occasionally be exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards. The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperature conditions. The noise level in the work environment ranges from low to moderate depending upon the task being performed. This position may require occasional travel. About Discovery Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 350 patents and 80 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

Our corporate activities are growing rapidly, and we are currently seeking an office-based Clinical Data Intern to join our Data Management team in Cincinnati, OH. Responsibilities * Validate entry database designs * Report metrics and data trends on projects * Identify data conflicts and issues on projects * Work with personnel from global research sites to resolve data conflicts * Reconcile data from multiple sources * Create and update study documentation on projects * Participate as part of a team on various projects Qualifications * Working towards a Bachelor's Degree in a Life Science or Health related field * Strong attention to detail and experience in Excel and Word required * GPA: 3.5 or above Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Our corporate activities are growing rapidly, and we are currently seeking an office-based Network Engineer Intern to join our Information Technology team. Responsibilities We have openings for entry level internships within the Core Infrastructure team at Medpace. The list below are samples of some of the technologies that we work with. While we desire candidates with experience in these specific technologies, we also understand that each of them has market alternatives, so the most important skillset a candidate can have is a good attitude and have a strong work ethic. Top candidates will have an aptitude to learn new technology and have a "do what it takes" attitude. The ideal candidate will have some familiarity and exposure to network fundamentals, switching, wireless, and firewall. Scripting and demonstrated ability to automate tasks and processes is a plus. * Cisco hardware * Meraki wireless * CheckPoint firewalls * SD-WAN with SilverPeak * zScaler ZIA and ZPA * SolarWinds network monitoring * Cisco DNA management Qualifications * Working towards bachelor's degree in computer science, Information Systems or a related field; * Strong desire to learn and grow, with a solid foundation of technical background and experience; * Ability to be self-directed with assigned tasks and ability to research solutions and come forward with recommendations for new and creative ideas to solve problems. * Ability to communicate effectively with peers, end users, and management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.