Charles River Labs jobs in Bethesda, MD

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** We are seeking an Animal Care Technician I to join our Insourcing Solutions team located in Bethesda, MD. As the Animal Care Technician I, you will work with our research animals to ensure they are well cared for. Additional responsibilities include: * Providing food & water. * Ensuring cages are clean. * Performing and recording daily animal health checks. * Handing & restraining animals for injections * Learning & applying quality assurance standards * Examining new animals that arrive at the site & helping them to settle in * Learn & become involved in breeding of multiple animal species. Job Qualifications The following are minimum requirements related to the Animal Care Technician I position: * Six months of animal experience (e.g., dog walking, pet sitting, kennel attendant, vet assistant, farm hand, 4-H background, pet store worker) * Must be successful in obtaining the ALAT (Assistant Lab Animal Technician) Certification within 1-2 years of eligibility * High school diploma/GED preferred The pay for this position is $20-22/hour USD per hour. Please note that salaries vary within the range based on factors including, but not limited to skills, certifications and locations. Schedule: Monday through Friday 7AM-3:30PM. Must be available some weekend and holidays if necessary **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **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 *************** 231338

Join us as a **Global Labeling Operations Manager** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global markets. In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely, and high-quality labeling updates. This is a unique opportunity to work on diverse programs, including pandemic products and flu campaigns, while contributing to the governance, compliance, and strategy of global labeling. Key Responsibilities: - Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership. - Coordinate readability testing (planning, team review, and communications) - Oversee translations for foundational markets (EU, CH, DE). - Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL). - Upload approved labels to internal systems (Documentum, Weblabel, intranet). - Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders. - Lead impact assessments for technical and global labeling changes across dependent markets. - Perform data entry in Trackwise/Veeva and prepare annual labeling reports. - Review and update submission content plans; prepare change control documentation for CCDS-driven changes. - Prepare and manage Structured Product Labeling (SPL). - Support advertising and promotional and marketing material reviews, educational materials, and social media compliance. - Ensure compliance with country-specific regulatory requirements. - Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: - University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. - Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility. - Experience leading teams in a matrix organization. - Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. - Experience with flu campaigns, pandemic products, and direct-to-consumer advertising. - Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems. - Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS. Competencies: - Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing. - Strong problem-solving skills with the ability to analyze risk and recommend solutions. - Effective communicator, able to explain complex concepts and influence cross-functional colleagues. - Excellent organizational skills with attention to detail and strategic thinking. - Ability to thrive in complex, matrixed, and cross-cultural environments. - Fluency in English (verbal and written); additional languages a plus. Why Join Us: - Work on impactful global programs that directly support patient safety and regulatory compliance. - Collaborate with a diverse, international team across multiple therapeutic areas. - Gain exposure to advanced regulatory systems and global labeling strategies. - Competitive compensation, benefits, and opportunities for career growth. If you're passionate about global labeling operations and ready to make a difference in patient safety worldwide, we'd love to hear from you. \#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.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Associate Director, Medical Science Liaison Purpose: Scientific and Clinical Experts (SEs/CEs) are individuals who are noted for their expertise in a therapeutic area and as a result have special needs for in-depth and cutting-edge scientific information, because they treat patients, design and implement novel research, and educate colleagues and students. The Medical Science Liaison (MSL) program is specifically designed to meet these needs through a field-based group of medical professionals with deep content knowledge about specific disease states, Lilly and competitive compounds and landscape in their respective therapeutic areas. MSLs recognize and communicate feedback and insights of strategic importance from their interactions with SEs and CEs, to better inform Lilly's strategic direction for research, development, and commercialization. By facilitating scientific exchange between industry and the scientific and clinical communities, MSLs shape the future of healthcare by providing the required information that addresses important clinical and scientific questions. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Scientific & clinical knowledge An MSL's objective is to provide leading researchers and practitioners with the scientific and clinical knowledge that is most meaningfully and precisely addresses their needs (e.g., addressing clinical care gaps for their patients, clarifying nuanced clinical or research questions). This role requires efficient and precise synthesis of the latest research on products, disease states and standard of care for specific indications and therapeutic areas (TAs). Such a skillset and the underlying depth of expertise is typically acquired through substantial research experience or clinical training and requires continuous learning to maintain the highest level of technical expertise within a given TA. This continuous learning will enable the MSLs engagement in scientific exchange to respond to the diverse medical information needs based on customer requests. As a result, the MSL will establish themself as a reliable, trusted, resource of unbiased, accurate, up-to-date, medical and scientific information. Full spectrum SE/CE support Through the application of emotional intelligence, strategic thinking, and a deep understanding of HCP needs, MSLs will act as one of the primary interfaces between Lilly Medical and SEs/CEs to deliver a positive experience and utilize MSL capabilities to support HCPs in sharing evidence and addressing clinical care gaps for improved patient outcomes. Additionally, MSLs connect SEs/CEs with other Lilly resources or internal business partners as appropriate and facilitate collaborative research opportunities. MSLs partner with clinical development in support of studies and investigators to accelerate the pipeline and evidence generation by delivering disease state and other scientific information aligned with site identification, selection, and recruitment. Field Execution, Geo Management and Productivity MSLs effectively analyze customer data, plan, and prioritize to engage assigned SEs/CEs most effectively through a combination of face-to-face and virtual engagement with an enterprise mindset. They will implement a strategic territory plan prioritizing core MSL activities, leverage analytical and supporting tools to execute it, and assume personal accountability for meeting performance expectations. There is also an expectation for compliant partnerships across all Lilly field roles sharing customers to create an appropriately coordinated experience. MSL will effectively utilize territory analytics for customer identification and routing prioritization. Strategic vision and leadership MSLs effectively synthesize and communicate actionable customer/clinical insights to internal Lilly Medical and cross functional teams. MSLs use good judgement in decision-making and escalate issues as appropriate. They cultivate internal networks and collaborate effectively across functions including working closely with other field-based colleagues. They embrace change, exercise strategic agility with evolving business needs and utilize innovative resources. MSLs should work collaboratively with peers and other Lilly colleagues. Within their own team, MSLs are expected to contribute to team goals and be an effective teammate. The MSL will execute the role compliantly, adhering to all governing internal and external requirements, procedures, and laws, demonstrating good judgment. Minimum Qualification Requirements: * Scientific / clinical acumen: * Advanced degree in health sciences (e.g., PharmD, MD, PhD in a medically related field) required. In addition to PharmD, MD, PhD minimum of two years of relevant clinical or TA experience desired. OR * Masters or bachelor's level degree in health sciences (e.g., BSN, RPh, PA, NP) considered if 5+ years clinical, research, or industry experience (medical or scientific role) in relevant therapeutic area. * Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. * Valid U.S. driver's license and acceptable driving record. * Interpersonal, presentation, planning, and digital skills: * Learning agility to comprehend and effectively communicate large amounts of complex scientific content in a clear and concise fashion. * Demonstrated experience in effective strategic and critical thinking to analyze, assess, and evaluate information and interpret impact or relevance to future states. * Advanced presentation and computer skills with expertise in literature identification, with a preference for experience in servicing customer needs for complex information. * Excellent verbal and written communication skills. * Self-directed and able to work alone in the field effectively managing multiple priorities and projects. * Strong teamwork and interpersonal skills, including high emotional intelligence and the ability to engage in professional relationship building and networking. * Resiliency in managing complex challenges. * Intellectual curiosity about the field of science/medicine of specialization. * Ability and excitement to leverage field-based tools, adapting as technology advances to increasingly support engagement planning, communication, and many aspects of the job. * Location requirements * Applicants should live within the geography (Southern New Jersey, Pennsylvania, Delaware, Maryland, D.C., Virginia) and near a transport hub (airport/train station). * Field-based position requires ability to travel up to 80% and including weekend commitments. * Other Information/Additional Preferences: * Experience in field-based working environment highly valued. * Familiarity with health systems, academic communities, medical research, and medical education process highly preferred. * Knowledge and experience of digital platforms enablers to engage HCP virtually (e.g., zoom) and excitement to leverage field based tools highly valued * Gastrointestinal and/or thoracic oncology TA experience is strongly preferred. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#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.

**Title: Principal Real World Research Delivery Lead (RWRDL)** Are you ready to take on a challenge and accelerate your career? This is an **excellent opportunity for a self-driven, autonomous leader** eager for growth and progression. Parexel is seeking a **Principal Real World Research Delivery Lead (RWRDL)** to join our team and deliver innovative Real World Research (RWR) solutions for global clients. This is a great opportunity to join our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll **lead cross-functional teams** , manage **budgets and timelines** , and serve as the **primary client contact** for innovative RWD projects. We're looking for a **strategic project leader** with strong communication skills, adaptability, and a go-getter mindset. Experience in **RWD/RWE** , **data privacy** , and **drug development** is a plus. **Career Growth:** Shape new services, mentor emerging leaders, and gain visibility in a lean PM model. As a senior leader, you will: + **Lead cross-functional teams** and act as the primary client contact for complex RWR and RWD projects. + Oversee **project proposals, budgets, timelines, and milestones** while ensuring compliance with SOPs and data privacy standards. + Collaborate with multidisciplinary teams to design and implement RWR-enabled solutions. + Mentor junior team members and help shape new services in a lean PM model. **What We're Looking For:** + Strong **project leadership experience** with proven ability to manage multiple projects and decentralized teams. + Excellent **communication skills** , adaptability, and a proactive, go-getter mindset. + Knowledge of **RWD/RWE methodologies** , data privacy, and drug development processes. + Ability to thrive in dynamic environments and lead independently. **Preferred Experience:** + RWD/RWE expertise, commercial experience, and familiarity with late-phase clinical research. + Understanding of RWD platforms, project management systems, and GCP environments. **Education:** Bachelor's degree in a science or clinical-related field; Prince II or AMPM certification preferred. **Why Join Us?** + **Career progression** and visibility in a growing RWD space. + Opportunity to **develop new services and mentor emerging leaders** . + Work on impactful projects that shape the future of clinical research. If you're ambitious, adaptable, and ready to make a difference, **apply today and lead the way in Real World Research!** \#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.

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. Job Title: Entry level Research Associate (per diem) Clinical/Data Entry Work Location: onsite in Baltimore, MD (some of the data entry work can be done remotely after training) Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore, MD unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. What you'll do after training is completed (including but not limited): Clinical: You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results Prepare/monitor study supplies and stock levels in clinic/hospital. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Data Entry: Complete Case Report Forms/eCRF's according to sponsor expectations and set documentation standards for staff to follow. Review, monitor and address quality of data entry for accuracy and trends throughout the study. Maintain neat and legible documentation across all Case Report Forms. Review Case Report Forms to confirm capture of data according to protocol and amendments. Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries. Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions. Organize track and report status of data entry to ensure that study data timelines are met. Check, review and ensure timely submission of data clarifications/queries. Your Profile: Proven customer service experience in a fast-paced environment Background working in a medical or clinical setting Comfortable with prolonged periods of standing and walking B.S.+ in related life science field OR HS diploma/GED with relevant experience CPT/Phlebotomy is highly preferred Hours/Shift - please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits) Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift M-F 6:50am to 3:20pm) Minimum availability requirements: 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) Shift Details: Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend) Bi-monthly attendance may be required for training sessions, unless there are no mandatory trainings to complete Base Pay Range: $20.00 to $22.00 per hour (this role is eligible for shift differentials) Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. 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.

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. Job Title: Laboratory Technician - Day Shift (Per Diem) Work Location: onsite Baltimore, MD Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. Your time here: as a Laboratory Technician you will have a thorough understanding of study protocols and lab manuals, utilize various processing laboratory equipment and will perform various diagnostic laboratory tests. Additionally, Laboratory Technicians ensure sample processing is completed correctly, monitor the laboratory and supplies needed as well as drive efficiency and accountability within the unit. Starting your journey with Parexel comes along with an extensive induction program and ongoing training while following your individual career path. What you'll do after training is completed (including but not limited): Collect (as appropriate), process and store human biological specimens according to protocol. Perform standard diagnostic laboratory tests (for example pregnancy tests, urinalysis, and drugs of abuse tests). Prepare and organize laboratory equipment and facilities, documentation and schedules for studies. Identify and problem solve study-related issues as they arise, bringing it to the attention of the correct supervisor. Maintain a positive, results orientated work environment, building relationships with management, colleagues, and other departments, communicating in an open, balanced and objective manner. Your Skills: Experience working in a lab either in a professional setting or through university courses. B.S./M.A.+ in related life science field or HS Diploma with experience Commutable distance to the unit located in Baltimore, MD Understanding of laboratory procedures and best practices. Customer service experience in a fast-paced environment Hours/Shift - all shifts are onsite (no remote work) Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training during the day. Shifts are typically 6:50am to 3:20pm After training is completed: Minimum Availability requirements: 16 hours of availability a week (including 1 weekend shift) Shift Details: We are looking for adaptable candidates who primarily work the day shift 6:50am to 3:20pm during the week as well as weekend The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) Base Pay Range: $18.00 to $22.00 per hour Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. 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.

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** We are seeking a **Repository Specialist** for our **Insourcing Solutions** team based at our facility in **Frederick, MD** . As the **Repository Specialist** , you will receive, handle and inventory specimens of human, animal and/or plant origin at temperatures ranging from ambient to -195°C, as well as weigh and prepare samples for pickup, courier delivery and shipment. Additionally, you will be tasked with maintaining repository files for validation of data and preparation of reports, as well as review accumulated data for accuracy and prepare reports of information and sample data. Additional responsibilities include: + Assemble and display data for the storage and retrieval of specimens and for report preparation. + Perform freezer inventories, as well as operate and freeze specimens utilizing controlled-rate freeze equipment. + Participate in temperature/liquid nitrogen (LN2) liquid level monitoring and emergency response rotations. + Process and aliquot specimens. + Enter data into client's online repository database for sample tracking and inventory management. + Driving client vehicle to deliver and pick-up specimens locally. **Job Qualifications** The following are minimum requirements related to the **Repository Specialist** position: + High School Diploma or equivalent + Valid driver's license + A minimum of two years related office and administrative experience preferred + Experience working in a shipping/receiving environment with scientific data preferred An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. The pay for this position is $20.00 per hour. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **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. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. 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 *************** 231136

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.

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** We are seeking a Research Support Specialist I for our Insourcing Solutions site located in Poolesville, MD. + Prepare and administer research treatments; collect and record physiological data (weight, temperature, pulse, respiration) + Perform technical procedures as needed associated with the Animal Study Proposals in relation to NHP retroviral, human respiratory and flavivirus studies to include but not limited to blood collection, IV catheterization, intubation, broncho-alveolar lavage, tracheal and nasal lavages, documented research observations, and administration of research treatments + Must have a basic understanding of aseptic technique, anesthesia induction, monitoring, and recovery as well as drug dosage calculations and administration + Assist Veterinarian & Sr. RSS staff with surgeries and specialized procedures + Perform daily animal health observations and report any abnormal findings to veterinarian + Maintain electronic medical records, send daily emails regarding animal health information to vet staff + Collect, preserve, and prepare blood, urine, stool, and tissue samples + Participate in study related necropsies/tissue harvest + Set-up for procedures and prepare supplies and equipment + Ability to maintain freezer organization and sample inventory + Practice universal precautions appropriate to different levels of ABSL. Work safely with animal / human pathogen biohazards and help to maintain the research animal facility as a safe work environment / operation + Report any animal health, care, and / or wellbeing concerns to the appropriate facility management staff + Report any facility infrastructure issues, relative to the animal care and support areas to the appropriate facility management **Job Qualifications** The following are the minimum requirements related to Research Support Specialist I: - High school diploma or general education degree (GED) required. BS degree in Animal Science, Biology, or similar discipline, or A.A. in Veterinary Technology is preferred. - 2-3 years' experience working with non-human primates in biomedical research or 2-3 years Veterinary Hospital technical experience preferred. - Must have computer program proficiency such as MS Word / Access / Excel. Must have a proficient technical vocabulary. - RVT/CVT/LVT or LAT certification preferred The hourly range for this position is between $28/hour and $30/hour. Please note that salaries vary within the range based on factors including, but not limited to skills, certifications and locations. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **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 *************** 231066

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. **IMPORTANT:** In order to be considered for this position, **a resume/CV must be uploaded and submitted during the application process.** Please make sure work history and education are added correctly. **Job Summary** This is an entry-level position where you can gain experience and begin your career in life sciences. Training provided! As a Primate Technician I, you will be responsible for the daily care of research animals. Your contribution will ensure the health and well-being of our animals, as well as impact the lives of patients across the world. Work schedule: Sunday - Thursday, 6:00am - 2:30pm Responsibilities: + Providing food and water + Inspect feeding and watering devices for proper function + Cleaning and sanitizing cages and enclosures + Observe animals for overall health and wellbeing + Assisting with the movement of animals + Log animal care data and maintain accurate records + Other assigned duties, including restocking supplies Work Environment & Physical Demands: + Work is performed in an _warm,_ climate controlledenvironment. + PPE (protective equipment) includes regular use of surgical mask, cap, goggles, face shield, scrubs, and boots. + The warm setting, physicality of the job duties, and use of personal protective equipment (PPE), when combined, frequently cause employees to become hot and sweaty. + Job duties require employee to regularly stoop, crouch, kneel, and reach up with hands and arms to perform repetitive tasks, and walk and stand for extended periods of time. + Employee must be able to regularly lift, hold and/or move up to 50 pounds. **Job Qualifications** _If you possess the following qualities, we will train you in the rest:_ + High School Diploma or GED _preferred_ , but not required + Animal care experience _preferred_ + Previous experience in a physically demanding role + Previous experience maintaining records and complying with regulations and Standard Operating Procedures (SOPs) + Strong attention to detail + Enjoys being part of a team + Flexible and available to work holidays (on rotational basis) and overtime as needed The starting pay for this position is $19.75 per hour. **IMPORTANT: A resume is required to be considered for this position.** If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. **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 120 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 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. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. 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 *************** 230980

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. Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Then monitor the volunteer participants health status around the clock as per the trial protocol to ensure their safety and wellbeing. Develop professionally by gaining experience in delivering high-quality research projects in this growing sector. What you'll do after training is completed (including but not limited): Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU). Assume responsibility for patient care and study conduct assignments. Ensure that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assess compliance, symptoms, etc. per study protocol. Arrange for pre/post procedure laboratory work to be performed. Ensure that all established timelines relating to areas of responsibility and assigned projects are met. Participate and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives. Assess, monitor, record, and report patient's condition and reaction to drugs and treatments to the appropriate physician. Collect and prepare data. Organize and enter data into case report forms. Enter data into databases when required. Assist physicians in completing flow sheets in medical records and progress notes. Update and maintain the contents of the Clinical Study File. Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation. Act as participant advocate in the conduct of clinical studies. Qualifications At least 2 years working in a hospital or clinical setting BSN preferred or relevant work experience. Active Registered Nurse License in the state of Maryland Current Basic Life Support (BLS) certification. ACLS certification required within 6 months of start date Base Pay Range: $40.00 to $45.00 per hour Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. Parexel is dedicated to supporting, developing and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers here at Parexel. The following military career roles align with this position 66G, 66H, 68C, 4NOX1, 46NX, 66S, 66T, 290X. 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.

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. Job Title: Entry level Research Associate (per diem) Work Location: onsite in Baltimore, MD Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore, MD unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. What you'll do after training is completed (including but not limited): You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system and study logs, maintain appointment calendars, and operate company information systems and computer programs. Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results. Prepare/monitor study supplies and stock levels in clinic/hospital. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Comply with Quality Management (QM) department guidelines and perform corrections for QM, CRC and Monitor/Sponsor Representative in a timely manner. Your Profile: Proven customer service experience in a fast-paced environment Background working in a medical or clinical setting Comfortable with prolonged periods of standing and walking B.S.+ in related life science field OR HS diploma/GED with relevant experience CPT/Phlebotomy is highly preferred Hours/Shift - please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits) Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift - 6:50am to 3:20pm) After training is completed: Minimum availability requirements: 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) Shift Details: Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend) Bi-monthly attendance may be required for training sessions, unless there are no mandatory trainings to complete Base Pay Range: $20.00 to $22.00 per hour Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. 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.

Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access. Key Responsibilities Strategic CMC Leadership - Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios - Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads Submission & Documentation Excellence - Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions - Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes Cross-Functional Collaboration - Partner with manufacturing, quality, and external organizations to address CMC-related issues - Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers - Support planning and execution of Health Authority meetings, including mock sessions Process Optimization & Innovation - Identify and implement process improvements to enhance regulatory efficiency and readiness - Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions - Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer Regulatory Systems & Reporting - Experience with CPP application filing via eCATS and 510(j)(3) reporting through next Gen portals is a plus - Ensure audit readiness and version control through meticulous documentation and system management Qualifications Experience & Expertise - 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF) - In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus! Skills & Attributes - Strategic and proactive mindset with strong operational execution - Excellent analytical, problem-solving, and negotiation skills - Effective communicator with strong interpersonal, presentation, and leadership abilities - Ability to manage multiple projects independently in a matrixed, multicultural environment - Proficiency in Microsoft Office Suite and regulatory systems Education - Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field - Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred - RAC certification is a plus Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed. \#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.

**Parexel** is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. **Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global Medical Sciences team.** **The role can be based remo** t **ely in the US or Canada.** The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians. Primary activities will focus on **Medical Monitoring Delivery & PV Support** . The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician). **Medical Expertise** and experience in **Ophthalmology** is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc. **Client Relationship Building & Engagement,** including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor. **Business Development:** the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings. **Skills** + Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts + Client-focused approach to work + Excellent time management skills + Excellent verbal and written medical communication skills + Excellent standard of written and spoken English + A flexible attitude with respect to work assignments and new learning + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail + Willingness to work in a matrix environment and to value the importance of teamwork. **Knowledge And Experience** + Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in **Ophthalmology** , which is expected to be kept up to date. + A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred + Clinical practice experience + Good knowledge of the drug development process including drug safety, preferred + Experience in Pharmaceutical Medicine, preferred + Experience leading, mentoring and managing individuals/ a team, preferred **Education** + US Board certified in **Ophthalmology** or Canadian equivalent + Experience as a Physician in Industry or as a clinical trial investigator is required + Previous CRO experience is strongly preferred + Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship) The ability to travel 15% domestically or internationally is required \#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.

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** We are seeking an Animal Caretaker to join our Insourcing Solutions team located in Baltimore, MD As the Animal Caretaker, you will provide basic husbandry to rodents and lagomorphs, monitor environmental parameters for abnormalities and provide customer assistance to the investigative staff. Additional responsibilities include: - Perform daily animal husbandry duties to maintain quality and health of research animals, including: perform daily water bottle /automatic water line and cage checks; provide appropriate food and water; perform cage changing and/or cage cleaning. - Monitor environmental parameters and maintain written records - Assist with restraint and handling of various animal species. - Receive, inspect, and put away incoming animals; as well as provide for sentinel animals in each rodent housing area. - Operate equipment and perform general housekeeping. **Job Qualifications** The following are minimum requirements related to the Animal Caretaker position: - AALAS certification at the ALAT level within one year of eligibility - 1 year of related experience in animal care - 3 months working with lab animal species (rodents), preferred - High school diploma/ GED preferred The pay for this position is $21.00 USD per hour. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **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. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. 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 *************** 229126

We are looking to fill a **Scientist II or III - Metrology Specialist** 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 sponsorship.** **Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment** . This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement **Qualifications -** B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline + **Scientist II** - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience + **Scientist III** - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience **Responsibilities** + Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation + Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships + Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded equipment or software packages + Support the purchase, installation, and equipment qualification of new laboratory equipment + Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support + Originate and progress Notice of Event (NOE) and Change Management (CM) records + Perform and document investigations and assist in developing/implementing CAPA plans + Represent the laboratory on all aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and Experience** + Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks + Capable of working independently under moderate supervision + Strong verbal and written communication skills + Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators **Desired Skills and Experience** + Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. + Experience with computerized standalone systems GMP validation requirements + Familiarity with authoring relevant instrument standard operating procedures (SOPs) **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.

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** We are seeking an experienced Animal Support Technician to join our Insourcing Solutions team located in Bethesda, MD. As an Animal Support Technician, you will perform a combination of duties in client facilities, including temporary assignments of caretaking, cage wash, and similar duties. Additional details about this role: + Main area of support is cagewash and animal care. + Animal care includes monitoring animal health and welfare while performing health observations; animal husbandry duties: daily equipment checks; provide food and water; perform cage checks and/or changes, record animal health concerns, and administer treatments as prescribed. (Variety of lab animals are possible) + Cagewash support includes processing soiled caging/tanks and preparing new caging, ensure that parameters are met to meet sanitation, prepare, and set autoclave loads to designated cycle, and maintain a clean and organized cage wash area. + Provide appropriate environmental enrichment, assist with restraint, handling, and manipulation of various animal species. + Receive, inspect, and house incoming animals, and maintain accurate records of animal breeding, health, and housing/isolator or support areas. + Assist with the receipt, stocking and maintenance of supply inventories, feed, bedding, etc. + Maintain facility equipment and perform routine preventative maintenance on cagewash and autoclaves. + May assist with technical procedures, such as providing treatments, blood and/or tissue collection, injections, surgical prep, administering anesthesia, and assisting with surgical procedures. Assist with breeding and weaning procedures to ensure appropriate production levels. + May assist with diagnostic services such as necropsy, health surveillance, etc. **Job Qualifications** The following are minimum requirements related to the Animal Support Technician position: + B.S. in Animal Science, Biology, or Biological Science preferred. + A.S. in Biology, Biological Science, Animal Science, or Veterinary Technology and 6+ months' animal care experience required. + Obtain AALAS certification at the Assistant Laboratory Animal Technician (ALAT) level upon eligibility. + Position requires travel between local sites to support client needs, must have valid drivers license and reliable personal vehicle. The pay for this position is $20 USD per hour. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **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 *************** 231034