Parexel International jobs - 334 jobs

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. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading obesity global studies. Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior role of Senior Project Leader. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. 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.

Join our Information Design team in Cincinnati! Medpace is a contract research organization (CRO) with a mission to advance new and better medical treatments that improve lives. As our creative services expand, we are seeking highly motivated and organized creative coordinators who will leverage passion and experience to make a difference. As a Creative Coordinator, you will be an integral member of the Information Design team-a group of writers, designers, technical communicators, and other creative individuals who are passionate about improving lives. We provide creative guidance and develop compelling content, branding, documents, and trainings for a wide audience. Responsibilities * Evaluate newly awarded clinical studies to assign the appropriate creative team * Serve as the point of contact for study teams requesting creative services * Attend meetings as a liaison for the creative team * Schedule creative meetings, track projects, maintain notes, and discuss timeline considerations * Determine project timelines and assign tasks using projections from managers and project management software * Develop materials using established brand guidelines (e.g., advertisements, brochures) Skills/Characteristics * Understand and appreciate the world of design * Track the status of multiple projects and teams simultaneously Qualifications * Bachelor's degree in a creative field strongly preferred; * Candidates local to Cincinnati area preferred; * Willingness to work fully office-based; * Prior experience working in a professional environment and * Excellent computer (MS Office, Adobe), communication, and organizational skills 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 * 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 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 Associate 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: * Infectious Disease * Cardiology * Oncology * Endocrine * 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 (i.e. cardiology, infectious disease, oncology, endocrine) * 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.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created 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. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + 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. + Medical responsibility as co-author for the 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. + Responsible for providing medical input into the 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. + 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 (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute 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. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + 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. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support 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. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + 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 + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#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.

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** A Research Analyst II supports the receipt, login, distribution, and disposal of materials utilizing the appropriate software systems. Staff manages reagents, test materials, matrices, regulated and non-regulated samples, and laboratory consumables. Staff also supports all disciplines by storing, distributing, and archiving regulated and non-regulated samples and study material within the appropriate software systems. Staff are also knowledgeable in the application of GxP's and applicable SOPs, along with adhering to study protocols to accurately receive, store and dispose of laboratory materials. Essential Duties and Responsibilities * Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.) * Independently maintains disposition of study specific materials * Assist with laboratory support functions such as labeling/verification and receiving/login supplies * Assist with maintaining study specific inventory consumables with minimal oversight * Demonstrate effective communication skills through informal discussions with peers, supervisor, and team * Manage receipt and maintenance of test (or archiving) materials and laboratory consumables * Participate in process improvement initiatives with minimal oversight * Monitor laboratory (or archiving) storage units for compliance with SOPs/protocols * Ensure laboratory waste is properly disposed of to designated areas * Assist in the completion of laboratory investigations, assay troubleshooting and quality observations with minimal oversight * Perform verification of receipt records for accuracy and compliance with SOPs and protocol * Independently execute proper receipt of test (or archiving) materials * Independently prepares domestic shipments * Independently manage international shipments * Oversee and maintain responsibility for specific functional area with minimal oversight * Perform clinical and non-clinical sample disposition and archive with oversight as needed * Perform verification of shipments with oversight as needed Job Description: * Perform verification of clinical receipt records for accuracy and compliance to SOPs and study plans * Operate specialized equipment (e.g. BSC, Nitrogen Atmosphere Glovebox) with minimal oversight as needed * Perform log in, storage and aliquoting of Controlled Compounds as required by operational area with minimal oversight * Perform all other related duties as assigned **Job Qualifications** + Education: HS/GED/Associate's degree or equivalent with a minimum of 3 years of relevant experience. Bachelor's degree (BA/BS) in a relevant field with 1-2 years work experience + Certification/Licensure: None Other: * Ability to communicate verbally and in writing at all levels inside and outside the organization * Basic familiarity with Microsoft Office Suite * Computer skills, commensurate with Essential Functions, including the ability to learn a validated system * Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice * Ability to work under specific time constraints The pay for this position is $24.00/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Must be authorized to work in the United States without a sponsor visa, now or in the future. **About Safety Assessment** Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. **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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 230875

Our clinical operations activities are growing rapidly, and we are currently seeking full-time, office-based Study Start-Up Coordinators to join our Regulatory Submissions team. In this position you will work independently and collaboratively to manage timelines, meet goals, and play a key role in the clinical trial management and study start-up process at Medpace. If you are seeking an exciting, entry-level position where you can build a foundation in the clinical research industry and develop/grow your career through our robust training program, then this is the opportunity for you. Responsibilities * Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial; * Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); * Collect, review, organize, and assemble regulatory start-up submissions (includes submissions to Institutional Review Boards); and * Maintain timelines for study start-up through internal team collaboration. SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAM Medpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence based learning & development models to advance professional learning and employee performance. In the program, you will… * Complete independent learning modules, interactive exercises, and team workshops through the core curriculum; * Gain exposure to real-world tasks through a robust mentoring program; and * Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials. Qualifications * A minimum of a Bachelor's degree is required (preferably in a Life Sciences field); * Minimum 3.0 GPA; 3.5 GPA and above preferred; * Some experience in an office setting is preferred; * Excellent organizational and prioritization skills; * Knowledge of Microsoft Office; and * Great attention to detail and excellent oral and written communication skills. 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.

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. We are seeking a motivated Regulatory Affairs Consultant - Advertising & Promotion to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust. Key Responsibilities • Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content. • Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development. • Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. • Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements. • Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. • Support preparation of responses to regulatory inquiries related to promotional activities. • Track and manage promotional submissions and approvals in regulatory systems • Manage SOPs and electronic review systems. Qualifications • Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field. Experience: • 3-5 years of pharmaceutical/biotech related industry experience. • Direct experience in advertising and promotional regulatory review. • Familiarity with FDA regulations governing promotional materials. Skills: • Strong organizational skills with the ability to manage multiple projects under tight timelines. • Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners. • Attention to detail combined with strategic thinking. • Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS). • Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards. Competencies: • Knowledge of US regulatory requirements for advertising and promotion. • Demonstrated problem-solving ability and sound decision-making. • Ability to work effectively in a matrix environment and collaborate across diverse teams. • Strong interpersonal skills with cross-cultural awareness. • Fluency in English (verbal and written). #LI-LB1 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 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 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: 7AM-3:30PM 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.

Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities. This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence cross‑functional teams in a fast‑changing environment. Key Responsibilities: Documentation & Compliance - Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements. - Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). - Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals. Regulatory Submissions - Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. - Provide local input for change control and post-approval requirements. - Collaborate with global functions to obtain documentation aligned with local requirements. Audit & Inspection Support - Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure. - Provide local expertise and responses to inspection queries. Cross-Functional Collaboration - Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes. - Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies. Strategic Leadership - Lead regulatory strategies for product launches and integrations at the affiliate level. - Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships. - Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation. Education - Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent. - Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences. - Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus. Experience - 3-5+ years of local regulatory knowledge and experience in a health authority-facing role. - Demonstrated previous life cycle management experience is required. - Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. - Proven expertise in managing regulatory submissions, timelines, and cross-functional teams. - Strong project management and leadership skills. - Experience influencing Commercial Operations stakeholders and driving business-critical decisions. - Demonstrated ability to adapt and succeed in rapidly changing environments. \#LI-LB1 \#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, office-based Data Engineer Intern to join our Information Technology team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. Responsibilities * Utilize skills in development areas including data warehousing, business intelligence, and databases (Snowflake, SQL Server, Azure Sql); * Support programming/software development using Extract, Transform, and Load (ETL) and Extract, Load and Transform (ELT) tools, (dbt, Azure Data Factory, SSIS); * Design, develop, enhance and support business intelligence reporting primarily using Microsoft Power BI; * Collect, analyze and document user requirements; * Participate in software validation process through development, review, and/or execution of test plan/cases/scripts; * Create software applications by following software development lifecycle process, which includes requirements gathering, design, development, testing, release, and maintenance; * Communicate with team members regarding projects, development, tools, and procedures; and * Provide end-user support including setup, installation, and maintenance for applications. Qualifications * Working towards a Bachelor's Degree in Computer Science, Data Science, or a related field; * Excellent communication skills; and * Excellent analytical and problem solving skills. 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 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 -** **Third Shift** **Analytical Chemist Pilot Plant** 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. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **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.

Medpace is expanding a new Clinical Informatics team and is looking for qualified students to support this team. Our interns work directly with our analysts to develop operational solutions spanning data analytics, visualization, and accessibility. These solutions are launched for Clinical and Medical Operations teams at Medpace who work directly with sponsors and sites leading and participating in clinical trials for pharmaceutical development. These data products increase operational efficiency and can be categorized into either custom- or enterprise-wide solutions. Interns will work hand-in-hand with our software engineering team to bring these solutions to production. Interested candidates should at least have introductory experience in R or Python programming. Preference will be given to candidates with additional experience in (i) SQL, (ii) application development in Shiny or Streamlit, or (iii) dashboard development in PowerBI, Tableau, or Spotfire. Interns will have daily programming responsibilities in R, Python, and SQL (project-specific). They will be trained on Medpace's relational database architecture to effectively query and wrangle data. Interns will be expected to support the development of innovative web applications to help operational teams process, analyze, and visualize data. The Clinical Informatics team are looking for individuals who thrive in collaborative environments, are able to work effectively in international settings, and are flexible to support the development of this new team. If you are an individual with a background in data science, informatics, or clinical analytics, please review the following career opportunity. Responsibilities * Participate in analysts' evaluation of data needs for assigned projects; * Work alongside analysts to contribute innovative data products; * Interact with relational data at both study- and enterprise-level inclusive of actions for query, wrangling, analysis, and reporting; * Contribute to algorithm development for descriptive, classification, and predictive operational purposes; and * Support departmental process improvement initiatives. Qualifications * Enrollment in Bachelor's program for informatics, computer science/engineering, biomedical engineering, health information, statistics, or related field; * Analytical thinker with great attention to detail; * Ability to work effectively on a sprint schedule; * Strong verbal communication skills; * Programming experience in R or Python; * Clinical research experience is preferred; * Experience building web applications is preferred (with either Shiny or Streamlit); and * Experience building dashboards is preferred (with either PowerBI, Tableau, or Spotfire). Additional Considerations We are hiring all levels of experience for our internship. Candidates in Bachelor, Master, or Doctoral programs are encouraged to apply. Interns will be required to work full-time, in-person hours during the applied semester. 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 has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created 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. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + 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. + Medical responsibility as co-author for the 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. + Responsible for providing medical input into the 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. + 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 (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute 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. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + 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. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support 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. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + 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 + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#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.

If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: + Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project management skills with a track record of managing complex projects and meeting deadlines. + Excellent organizational and communication skills. + Excellent time management abilities + Proficient in Microsoft Office Suite + Proven experience with project management software ie. Smartsheet + Strong communication and interpersonal skills + Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: + Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones \#LI-LB1 \#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.

Responsibilities * Prepare samples according to project protocol and/or related SOPs; * Maintain compliant laboratory documentation; * Perform data analysis and data checking; * Interpret results obtained for accuracy and acceptability; * Clean and sterilize laboratory equipment; and * Other duties deemed necessary. Qualifications * A minimum of a Bachelor's degree, with previous experience in a research laboratory; * Knowledge of GLP, cGMP, and ICH guidelines; * Strong organizational and communication (written and oral) skills; and * Knowledge of Microsoft Word, Excel, and Powerpoint. 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.

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.