Charles River Labs jobs - 131 jobs

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 individual for our Corporate Counsel - Labor & Employment position within our Legal Department. Working with other members of the legal labor and employment team, provide analysis and counsel to management and HR on global labor and employment issues including recruitment and hiring, discipline, reorganizations, training, company policies, employee handbooks, compensation and benefits issues, etc. Draft, negotiate and review documents relating to executive employment, as well as general HR-related contracts including separation agreements. Develop and recommend company policy and position on worldwide labor and employment issues to ensure company compliance with local, state and federal regulations related to employment (Affirmative Action, ADA, FLSA, FMLA, EEOC, MCAD, NLRB, USERRA etc.) and related regulations in other jurisdictions where employees are situated. Handle employment -related litigation, mediations, hearings (EEOC, etc.), and arbitrations. Anticipate and guard against labor and employment legal risks facing the company. Provide general legal support, when appropriate. **Position is remote and will require occasional domestic and international travel. Essential Duties and Responsibilities + Provide analysis and counsel on labor and employment issues globally. Key areas include recruitment and hiring, discipline, reorganizations, training, company policies, employee handbooks, compensation and benefits issues. + Assist with legal compliance initiatives (policies, trainings, processes, etc.) related to employment and labor areas for the global workforce, as well as in other areas requested from time-to-time, and otherwise provide support generally to members of the legal compliance function. + Draft, negotiate and review documents related to senior executive employment and compensation, including benefits plan documents (including ERISA, COBRA and 409A issues), change-in-control agreements, and employment offer letters. + Draft, negotiate and review both routine and complex HR-related contracts including separation agreements. + Prepare and conduct training for HR and business partners on labor and employment issues and best practices. + Provide counsel on employment disputes, including EEOC, NLRB, MCAD and other discrimination complaints. + Recommend, advise and enforce company policy and position on worldwide labor and employment issues to ensure company compliance with local, state and federal regulations related to employment (Affirmative Action, ADA, FLSA, FMLA, EEOC, MCAD, USERRA etc.) and related regulations in other jurisdictions where employees are situated. + Manage outside counsel on employment litigation matters. + Review employment, labor and benefit issues as part of our acquisitions and divestiture teams, and provide related advice, counsel and risk assessments during the evaluation process. + As requested, serve as Legal Department representative on acquisition integration processes. + As requested, serve as Legal Department representative on Policy Management Committee. + Provide legal counsel on issues arising from actual or anticipated employment-related lawsuits. + Assist in the development and recommendation of company policy and position on employment-related legal issues. + Monitor and analyze changes to employment-related laws and regulations to ensure continued company compliance. Proactively advise management on changes which may affect the business and recommend actionable guidance. + Establish a strong partnership with HR and business teams, providing practical and sound labor and employment advice. + Provide backup legal support for general corporate legal issues as required. + Perform all other related duties as assigned. (Note: Position may be requested in the future to also serve as principal counsel to one or more businesses or functions, including coordinating the delivery of legal services to the businesses/functions and collaborating and establishing strong relationships with their respective leadership teams.) **Job Qualifications** + Education: Bachelor's degree (B.A./B.S.) and Juris Doctor or equivalent from an accredited law school. + Experience: Five or more years of related experience, preferably in a combination of a law firm and corporate setting. + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + Certification/Licensure: Current license in any US State Bar as an attorney qualified to practice law. + Other: Knowledge of labor/employment-related statutes and regulations. Strong interpersonal and communication skills. Compensation Data The pay range for this position is $180K - $210K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 *************** 231226

Experienced managers in a key account management function, responsible for agreed upon targets for the assigned accounts. Primarily responsible for key stakeholder relationships within targeted accounts, develop deep understanding of individual customer needs and identify mutually beneficial solutions for both Novartis and customers through creation and execution of account business plans. Cellular Therapy Strategic Account Manager - New York City Territory - Remote (MD, DE, PA, NJ, Greater NYC) Please note that this role would not provide relocation and only local candidates will be considered. About the Role Major accountabilities: * Responsible for complete ownership of assigned Key Accounts; develop product specific and portfolio strategies in line with goals and customer needs; align Account strategy with other key Sales, Marketing, Patient Access, Medical and Managed Care functions and ensures cross-functional resources and support. * Delivers the Account plans and required financial results for own Key Accounts; works effectively with colleagues in other functions (e.g. Primary Care and Specialty Sales, Marketing etc.) to achieve account sales. * Responsible for contract optimization, access and reimbursement across the specific customer groups that are relevant to the role or business unit. * Leads negotiations, contracting, pull-through and formulary management with assigned Key Accounts -Creates and implements programs designed to build long-term relationships with Accounts, based on deep understanding of the customer organization, structure, business strategy and priorities -Builds and sustains long-term customer partnerships with assigned Key Accounts, based on deep understanding of the customer organization, structure, business strategy and priorities. * Leads cross-functional Account teams and other assigned resources to develop and deliver Account business plans. * Acts as mentor to other Key Account Managers by sharing best practices on contracting, Account plan development and execution and knowledge of product/disease states, customer segments, and healthcare environment and regulations. * Communicates customer insights and Account-related activities to internal stakeholders, and engages with them to pursue business opportunities within assigned Accounts. * Plays a key role in negotations at the regional level and provide strategic inputs and support to the team (as applicable) -May be responsible for leading the tender business and team within the country by coordinating all related activities and stakeholders at local/regional levels -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: * Sales revenue and revenue growth in assigned accounts -Portfolio and strategic customer development Minimum Requirements: Education: Bachelor's Degree Required Experience: * Minimum of 5 years pharmaceutical experience and 3 years of total experience in one or a combination of the following areas: Key Account Management, Reimbursement, Medical Device or sales management required. * Demonstrated record of success in Oncology, Hematology, or Transplantation within an Academic Institutional setting strongly preferred * Proven ability to establish and cultivate key customer relationships * Strong Strategic and Business Acumen skills * Strong negotiating skills * In depth knowledge of healthcare industry, environment and * IDNs/ACOs/Government Accts preferred NOTE: Above level experience criteria are not an exhaustive list Skills: * Account Management. * Accountability * Matrixed Collaboration * Commercial Excellence * Competitive Intelligence * Complexity Management * Compliance * Crm (Customer Relationship Management). * Customer Engagement * Enterprise Sales * Ethics * Heathcare Sector * Integrated Marketing. * Market Development. * Problem Solving Skills * Revenue Growth * Sales Strategy. * Selling Skills * Strategic Leadership * Value Propositions * Process Education US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Field roles with a dedicated training period only: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: ********************************************************** Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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: Data Management Lead (Medical Affairs) - Oncology Location: Fully Remote (US based) Must be able to accommodate West Coast hours. About Us: At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you! Who You Are: Required: BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience. 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data) Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology Strong project management experience Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required). Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity. Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing. Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques. Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment. Ownership and accountability relative to key accountabilities in the job description. Ability to travel as required. Written and oral fluency in English. Preferred: Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI). Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau). Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming. BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions. What you will be doing: Responsibilities will include: Develop risk management strategies and proactively manage timel What ines to ensure successful oversight and delivery of studies and projects. Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones. Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models. Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data. Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results. Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis. Cross-functional Data Management Leadership: Manage and coordinate the integration and utilization of all ancillary systems. Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan. Review and analyze metrics to derive meaningful summaries of study health and trends. Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators. Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs. Project Financial and Resource Management: Ensure appropriate project-level resourcing of staff and staff assignments. Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand. Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope. Company Initiatives: Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole. Support other functions by providing meaningful feedback on initiatives. Ensure Parexel-requested information entered into management systems is accurate and regularly updated. Training: Maintain training compliance as per job roles assigned, including on-the-job training. Deliver project-specific training to internal Data Management teams. Address training needs based on identified development goals. 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.

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. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered 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 $177,000 - $338,800 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

#LI-Remote The Associate Director, Access & Reimbursement, Oncology - South Texas is a remote & field-based role that covers the following, but not limited to: San Antonio, TX, Houston, TX, and Austin, TX. Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border. The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care. ADARs will serve as the patient access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding education (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects. ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third party affiliates). About the Role Key Responsibilities: * Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows. * Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices. * Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products. * Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient reimbursement and provide support on reimbursement issues with third party payers at the provider-level. Analyze account reimbursement issues (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient access to Novartis medicines * Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments. * Accountable for informing customers on NVS-sponsored patient support programs to help enable patients starting and staying on therapy (i.e., Co-pay). * Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed). * Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education. * Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement. * Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance guidelines). * Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes. Buy and Bill Specific * Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel. * Responsible for educating HCPs using approved materials regarding acquisition pathways for Novartis products. Educate on buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate site of care for administration. * Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement. * Analyze reimbursement issues, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams. * Accountable for engagement with non-prescribers in regards to Novartis medicines, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc. Essential Requirements: * Education: Bachelor's Degree required. Business and/or biological science education preferred. Advanced degree preferred. * 5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s). * Experience working with highly complex practices and/or health systems to establish access and acquisition pathways. * Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access. * Deep expertise and experience integrating manufacturer-sponsored patient support programs. * Experience with specialty products acquired through Specialty Pharmacy networks * Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail) * Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region. * Must live within assigned territory. * Ability to travel and cover geography, at least 50% travel required, based on geography and territory / targeting make up. * Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. * Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. * The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. Desirable Requirements: * Experience leading and delivering presentations to C-level account executives. * Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management and applicable third-party affiliates. * Expertise in therapeutic area practice dynamics and common reimbursement and product program support-related needs. * Strong capabilities in the areas of customer focus, collaboration, business acumen, communication, and presentation skills. * This position requires significant use of a company provided vehicle and maintaining good driving record * This is a field-based customer engaging position * Control business expenses related to field activities (i.e. travel, customer meetings) and provide timely expense reports to manager. Novartis Compensation Summary: The salary for this position is expected to range between $160,300 and $297,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to ********************************** The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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. Position Title: Design + Human Factors Engineering Senior Director -DDCS Department Name: Delivery, Device and Connected Solutions Purpose: In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years. In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company. This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries. Position responsibilities: Design and Human Factors: Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio. Ensures that: Human capabilities and limitations are adequately reflected in the system requirements Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs) Human performance and safety risks are appropriately addressed in planning. The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance. Human Factors Standards are appropriately documented in the Design Control Quality System. Project milestones are met by identifying and managing risks and escalating as appropriate. Functional budgets and project forecasts are maintained in compliance with P&L People: Responsible for developing and managing the Design + Human Factors Engineering team. Provides leadership, feedback, coaching, performance and career development support to direct reports. Ensures career development discussions, talent assessment, and succession planning are in place for employees. Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization. Strategy / Corporate Integration: Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team. The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects. Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry Relationship Management: Ensure compliance with external collaborations Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units) Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve Minimum requirements: MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience. Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products. Experience working within a Sponsor organization Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting. Human subjects research bioethics and study design Prior supervisory experience of team organization Ability to work effectively across boundaries Demonstrated quality mindset, ability to influence and leadership capabilities Additional Skills and Preferences: Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75) Business skills (capital and expense differentiation and impact on COGS and variance). Communication and interpersonal skills necessary for broad interactions at all levels of the corporation. Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.). Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners. Leadership skills with previous experience managing technical personnel and alliance partnerships Demonstrated ability to lead cross-functional teams Additional Information Position Location: Indianapolis, IN Ability to travel ~10-20% of the time, both domestic and international 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 $163,500 - $264,000 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

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 Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable GLP regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Assure Charles River's compliance with applicable GLP . Communicate all identified compliance and quality risks to supervisor. * Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, SOPs, and protocols. * Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable GLP regulations. * Maintain written and signed records of all audits and inspections as required and sign records documenting the performance of audits and inspections and reporting to management. Identify deviations from GLP regulations, protocols and SOPs. * Independently perform inspections to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with GLP regulations. Assist in scheduling and tracking QA audits, inspections and procedures as requested. * Perform all other related duties as assigned. Job Qualifications * Education: Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline. * Experience: 1-2 years experience in QA role * Certification/Licensure: None. * Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing. PHYSICAL DEMANDS: * Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. * Must regularly communicate with employees/customers; must be able to exchange accurate information. * May occasionally be required to wear protective clothing and equipment. WORK ENVIRONMENT: * General office working conditions and/or laboratory/manufacturing areas. * The noise level in the work environment ranges from low to moderate. * May occasionally be required to work in tight or confined spaces. * May occasionally be exposed to high temperatures and humidity. COMMENTS: * May require occasional domestic travel. The pay range for this position is $50-60k/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Must be authorized to work in the United States without a sponsor visa, now or in the future. About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231310

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading obesity global studies. Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior role of Senior Project Leader. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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 Technician I, Technical Operations for our Safety Assessment site located in Ashland, OH. Candidates will train 5-9 weeks 1ST SHIFT (TUES-FRI 6AM-430PM) before moving to weekend shift hours (6AM-630PM) Friday- Sunday or Saturday- Monday. A Technician I is in training to perform and become proficient in on-boarding skills, procedures, and cooperating in a team environment. The technician is learning basic skills required to support a study, which may include animal handling, husbandry, observations, basic physiological indices, and data collection/recording to support each skill. The technician may occasionally perform basic skills independently but continues working under supervision to gain proficiency on skills still in development. Essential Duties and Responsibilities: (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: Ensure good welfare and humane care for all animals worked with through gentle, positive human animal interactions. Train in on-boarding skills which may include animal handling, husbandry, observations, basic physiological indices, and data collection/recording to support each skill. Specific tasks will be based on each area's training plan and business needs. Collect, document, review, and verify data on forms, or in electronic data capture systems. Ensure high levels of study quality to meet study goals. Follow all PPE, safety, cleaning, and cross-contamination elimination practices. Maintain appropriate communication with other personnel. Support team-mates, technicians, and members of other departments. Follow direction from team leaders, trainers, research associates and supervisors. Use and maintain instrumentation and equipment according to SOPs. Perform all tasks per SOP, BOP, and/or protocols. Perform all other related duties as assigned The starting pay for this position is 19.00 per hour + 10% shift differential on weekend days (Sat & Sun). Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location. Job Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: Education: High school diploma or General Education Degree (G.E.D.) preferred. Experience: No previous experience required. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure: None. Excellent written and verbal communication skills. Ability to manage multiple tasks and priorities to achieve goals. Computer skills (e.g., Microsoft Office Suite), commensurate with essential functions, including the ability to learn a validated system. Ability to ensure that a safe working environment is maintained by observing all safety procedures and working methods by making proper use of protective clothing and equipment, and by reading, understanding, and following all safety documents issued or notified of. Ability to ensure the integrity of the studies and fulfill the regulatory agencies requirements by performing the activities according to the Good Laboratory Practices (GLP), Standard Operating Procedures (SOP), Business Operating Procedures (BOP) and the Institutional Animal Care and Use Committee (IACUC) rules. Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice. Ability to work under specific time constraints. Must be authorized to work in the United States without a sponsor visa, now or in the future. Physical Demands: Employees must be able to lift, move, manipulate, and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or animals. Must be able to perform laboratory procedures, which require, talking, hearing, standing, or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus. Work Environment: Work in a research environment, which requires use of sharp objects, working around mechanical parts, working with or near known or unknown toxic or caustic chemicals and/or biological hazards, exposure to fumes and airborne particles, working at noise levels ranging from moderate to loud. The employee regularly works with live animals with risk of exposure to allergens, zoonotic disease, and biohazards. The noise level in the work environment ranges from low to high depending upon the species housed. Comments: This position requires overtime, weekend, holiday, and/or after hours shift coverage, as needed. About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River 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. 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 ***************

Join Parexel's team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. **Job Title:** Market Development Analyst At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients. We are seeking a Market Development Analyst to join our team. As a Market Development Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences for patients by connecting new clients with Parexel's capabilities. Through the collaboration, and diversity, of teams the Market Data Analyst is provided with multiple opportunities to excel and discover where your skills can take you. **Who we're looking for:** + Excellent communicator to effectively present information and respond to questions from groups of managers, clients, customers, and other business units + Analytical mind to read and interpret general business periodicals, professional journals, and technical procedures + Strong interpersonal skills with the ability to establish and maintain effective working relationships + Quick learner who excels in a rapidly changing environment + Practical problem solver + Minimum 2 years' experience in B2B lead generation or sales role **What you'll do:** + Work strategically with Marketing and Sales Teams to generate marketing campaigns for all lines of the Parexel business including promoting webinars, customer days and other marketing-driven events. + Analyze potential opportunities and develop strategies to support increasing client awareness and engagement; monitor actions and results against plans + Schedule introductory business development calls between sales team members and target company decision-makers. + Work closely with Sales Associates and Account Executives to ensure smooth transfer of information and accounts. + Collaborate with Director of Market Development, senior Sales staff, and Subject Matter Experts to develop market strategies to generate leads with new clients; re-engage past clients, and within current core accounts across all Parexel service lines. + Respond to Parexel web leads / inbound requests as first point of contact to conduct needs assessment + Track all activity with prospects and clients in Parexel's CRM system + Other responsibilities as assigned **Additional details:** + Prior CRO, life sciences, or consulting company experience preferred but not required **Why join us:** + Be part of groundbreaking projects that are pushing the boundaries of the industry. + Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. + Enjoy work life balance and flexible working hours. **Parexel US Benefits:** + Health, Vision & Dental Insurance + Tuition Reimbursement + Vacation/Holiday/Sick Time + Flexible Spending & Health Savings Accounts + Work/Life Balance + 401(k) with Company match + Pet Insurance + Full list of benefits available here: *********************************** If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors. \#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.

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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** Charles River Laboratories is seeking a Director of Business Intelligence to lead the development and execution of our global market, competitor, and customer insights strategy. This leader will serve as a trusted advisor to senior executives and business units by transforming data into actionable intelligence that guides decision-making, shapes strategy, and accelerates growth. The Director will oversee a team of analysts and data professionals, build best-in-class BI capabilities, and ensure that insights directly inform commercial, operational, and investment strategies. ESSENTIAL DUTIES AND RESPONSIBILITIES: Leadership & Strategy * Define and lead the global business intelligence function and strategy, ensuring alignment with Charles River's strategic priorities. * Partner with executive leadership, business units, strategic marketing, global technology, and other functional teams to translate data-driven insights into clear business strategies and initiatives. * Build and manage a high-performing team of BI analysts, fostering a culture of curiosity, rigor, and customer-centricity. Market Intelligence * Direct comprehensive analysis of the global life science research, biotech, and pharmaceutical markets, including growth trends, emerging technologies, and therapeutic pipelines. * Provide forward-looking insights into market opportunities, risks, and unmet customer needs. * Develop market models and forecasting tools to support strategic planning and investments. Competitor Intelligence * Establish a robust competitor monitoring program, covering key players by business unit and geo, new entrants, M&A activity, pricing strategies, and service/product innovations. * Synthesize competitor data into concise, actionable intelligence for executives and commercial teams. * Support scenario planning and 'war gaming' exercises to anticipate competitor moves and guide proactive strategy. Customer Intelligence * Lead advanced analysis of customer data, including segmentation, behavior, satisfaction, and share of wallet. * Partner with commercial teams to identify growth opportunities, improve customer retention, and guide go-to-market strategies. * Ensure customer voice and feedback are integrated into business and service/product decisions. Data & Analytics * Oversee the design and deployment of BI tools, dashboards, and reporting systems, in partnership with Global Technology, to make insights accessible across the organization. * Champion the use of advanced analytics, data visualization, and predictive modeling to improve strategic foresight. * Drive data governance, quality, and integration across multiple internal and external data sources. **Job Qualifications** * Bachelor's degree in Business, Economics, Data Analytics, or Life Sciences required; MBA or advanced degree preferred. * 10+ years of progressive experience in business intelligence, market research, consulting, or corporate strategy, ideally within life sciences, healthcare, or related industries. * Proven track record leading BI or insights teams with direct impact on corporate strategy and growth. * Exceptional analytical, critical thinking, and problem-solving skills with the ability to synthesize complex data into executive-ready insights. * Strong leadership and people management experience, with the ability to inspire and develop talent. * Excellent communication and presentation skills; adept at influencing senior executives and cross-functional stakeholders. * Deep understanding of life sciences/biopharma market dynamics, customer decision drivers, and competitive landscape. * Proficiency with BI platforms (Power BI, Tableau, Qlik, etc.), advanced Excel, and statistical/analytics tools (e.g., Python, R, SAS, SQL). Compensation Data The pay range for this position is $175K - $200K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 *************** 230898

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 is hiring an FSP Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician) to work remotely. Must be able to accommodated East Coast/CET hours. The ideal candidate will have key experience in NMA/Evidence Synthesis, Survival analysis, and HTA experience. Location: US - Remote | Employment Type: Full-Time Job Purpose The Statistician, Consultant, Advanced Analytics: Meta-Analysis, contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role involves working with junior team members to design, develop, and deliver client solutions across multiple projects-leveraging competencies in statistical theory, data analysis and interpretation, regression analysis, systematic review, and evidence synthesis methodologies. The individual must have a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other quantitative fields. Proficiency in data analytics and statistical software/tools such as WinBUGS, R, Stata, Python, and SAS is required. Key Accountabilities Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies. Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans. Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.). Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models. Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications. Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter. Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts. Additional Responsibilities The Consultant is responsible for ensuring that all assigned projects are conducted efficiently and that quality and client satisfaction are maximized-ensuring project direction and deliverables meet objectives and client needs. Consultants are expected to guide Senior Associates and Associates in their daily duties and flag any areas of acute training needs to their line managers. Supported by senior staff and Business Development partners, the Consultant is responsible for maintaining client relationships on their projects. Candidates will be part of multi-disciplinary research teams and will provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties may include: Preparing network meta-analysis protocols Reviewing data extracted from systematic literature reviews Conducting feasibility assessments Generating network diagrams Critically assessing study heterogeneity Conducting network meta-analysis Assisting with interpretation and dissemination of findings The candidate is also expected to support thought leadership and innovation objectives in advanced analytics, including but not limited to: Pairwise meta-analysis Mixed treatment comparison Indirect treatment comparison Network meta-analysis Match-adjusted indirect treatment analysis Meta-regression Single-arm trial analysis Simulated treatment comparison Surrogate outcome assessment Skills & Qualifications Master's or Doctoral-level degree in applied statistics, health economics, or related quantitative fields. Minimum of 3 years of hands-on experience in the pharmaceutical industry, consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus). In-depth knowledge of Access and HTA, clinical research and development methods, and international payer evidence requirements. Skilled in research design and statistical methods, such as Generalized Linear Models, Survival Analysis, Network Meta-Analysis, and Bayesian statistics. Proficient in R and GitLab (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus). Strong strategic, collaboration, and communication skills; excellent organization, planning, and prioritization abilities; ability to meet tight deadlines; and strong written and verbal communication skills in English. 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 Team Leader I - Operations Training for our Safety Assessment site located in Ashland, OH. Responsible for providing, coordinating, documenting and scheduling training sessions for onboarding and routine to highly complex training activities. Assist leadership team with the coordination for developing new technical training and for developing, revising, and implementing the use of training documents including SOP's and processes to support the overall company training program. Lead and mentor less experienced training personnel. ESSENTIAL DUTIES AND RESPONSIBILITIES: (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: + Work with department management and lead, coordinate and/or provide technical training at all levels of complexity for in-vivo department personnel. + Collaborate with Training Department management, cross-site personnel, and internal/external resources to develop and implement new training and improve the overall training program. + Assist in providing, coordinating, and scheduling new hire orientation and on-the-job training for personnel. + Ensure that all training provided meets quality and regulatory requirements. Provide additional training in these areas as needed. + Assist with coordinating biannual review for maintaining, developing, and updating all documents and databases used for the support and conduct of training tasks including but not limited to training standards, training records training timelines, and proficiency standards. + Perform technical tasks to support completion of study tasks (as needed). + Practice/maintain advanced technical skills and procedures, work independently, and follow SOP's and processes. + May conduct sponsor/visitor tours and interact with clients. + Assist with the development, review, and/or revise current processes, SOP's, training standards, quizzes, proficiency standards, and other training documents. + Lead and mentor less experienced training personnel. + Assist supervisor in prioritizing workload and preparing schedule. + Assist in the interview and selection of qualified non-exempt personnel. Assist in developing recommendations regarding personnel actions including hiring, promotions and raises. + Ensure that department equipment is maintained in good working condition and that department area(s) are maintained in a clean and orderly condition. + Serve as a model as it relates to effective time management, communication, and utilization of resources. Provide leadership and motivation to department personnel. + Perform all other duties as assigned. The pay range for this position is $26-30/hr per hour. Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location. **Job Qualifications** (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: + Education: High School diploma or General Education Degree (G.E.D.) required. + Experience: 4 years related experience with a at least 2 years in a training capacity + An equivalent combination of education and experience may be accepted in lieu of the specific education and experience listed above. + Certification/Licensure: AALAS certification at the Assistant Laboratory Animal Technician (ALAT) level preferred. + Other: Experience in the development of technical training programs and modules required. Experience in the delivery of instructor led training (ILT), synchronous on-line learning (e.g. webinars), and asynchronous (e-learning) methodologies preferred. Demonstrate advanced technical and analytical skills. Effective communication and leadership skills. Ability to handle a variety of laboratory animals. Proficient in technical skills and the operation of data collection equipment. Knowledge of GLP's and other federal regulations and guidelines relating to the care laboratory animals required. Understanding of basic, intermediate, and complex study design protocols. Ability to organize and prioritize work to meet deadlines. Computer literacy including word processing, spreadsheet, and database programs. _Must be authorized to work in the United States without a sponsor visa, now or in the future._ **About Safety Assessment** Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River 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. 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 *************** 231585

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. 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 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** Responsible for routine laboratory procedures (e.g., animal care, facility cleaning, labeling, lab support basic procedures, etc.), facility/groundskeeping, and/or other administrative/IT functions, as assigned. This is an onsite role in Ashland, OH. The pay range for this position is $15.00 - $17.00 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Must be authorized to work in the United States without requiring a Sponsor Visa. _Position is open to anyone, regardless of age, who meets the educational and experience requirements as posted_ **Job Qualifications** **ESSENTIAL DUTIES AND RESPONSIBILITIES:** * May perform area support cleaning, study set up, laboratory administrative functions, and/or basic animal husbandry. * May clean rooms and/or facility to include possible handling of biohazard materials. * May assist with use of balances and other laboratory equipment. * May perform basic facility/groundskeeping functions. * May perform administrative functions in various departments, including IT. * Use Good Laboratory Practice Regulations (GLP), SOP's and company policies when performing all job functions. * Perform all other related duties as assigned. **QUALIFICATIONS:** * Education: Currently enrolled in a degree program * Experience: Pipette experience, scientific knowledge, Prior ELISA, flow cytometry, multiplex, or genetic toxicology experience. * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. * Certification/Licensure: None * Other: Ability to handle common laboratory species in selected departments. **PHYSICAL DEMANDS:** * Employees must be able to lift, move, manipulate, and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or animals for the departments requiring such functions. * Must be able to perform procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards. * May be required to frequently firmly hold species while utilizing fine motor skills. * Specific vision abilities may be required by this job include close vision, color vision, depth perception, and the ability to adjust focus. * While performing the duties of any administrative-type functions, the employee may be assigned to regularly talk, hear and work/type at a computer. **Work Environment:** * If assigned to works in a research environment, it may require use of sharp objects, working around mechanical parts, working with or near known or unknown toxic or caustic chemicals and/or biological hazards, exposure to fumes and airborne particles, working at noise levels ranging from moderate to loud. * The employee may be required to work with live animals with risk of exposure to allergens, zoonotic disease, and biohazards. * The noise level in the work environment ranges from low to high depending upon the species housed and department assigned, if applies. **About Safety Assessment** Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River 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. 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 *************** 230218

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 Sample Management Technician for our Sample Processing Lab team at our Safety Assessment site located in Ashland, Ohio. The pay for this position is $19/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location Responsible for learning the daily tasks, performing, and becoming more efficient in skills required of the department training plan which ma include chain-of-custody procedure, packaging and shipping biological specimens, preparing manifest for domestic shipping, shipping labels, tracking shipments, unpacking incoming shipments, logbook QC, knowledge of Department of Transportation and International Air Transport Association (DOT/IATA) guidelines, and upholding all security procedures to main integrity, confidentiality, and excellent customer service. Essential Duties and Responsibilities: _(The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:_ + Assistant in shipping and packing of samples + Accurately prepare shipping packet. + Proficiently perform packet verification + IATA and DOT Training completed. + Handle and properly put away incoming shipments from other sites + Dispose of or archive necessary samples accurately and in a timely manner + Trained and proficient in AMS or File Trail + Other duties as assigned. **Job Qualifications** _(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:_ + Education: High school diploma or General Education Degree (G.E.D.) preferred.Experience: No previous experience required + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + Certification/Licensure: None, unless required by local government. + Excellent written and verbal communication skills. + Ability to manage multiple tasks and priorities to achieve goals. + Computer skills (e.g., Microsoft Office Suite), commensurate with essential functions, including the ability to learn a validated system. _Must be authorized to work in the United States without a sponsor visa, now or in the future._ Physical Demands + Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. + Regularly provides information to and receives information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange accurate information in these situations. + Must occasionally move about inside the office to access file cabinets, office machinery, etc. + Employees must be able to lift, move and/or hold up to 40 pounds; this includes work materials, equipment, and supplies. Work Environment + Ability to ensure that a safe working environment is maintained by observing all safety procedures and working methods by making proper use of protective clothing and equipment, and by reading, understanding, and following all safety documents issued or notified of. + Fine motor skills and hand dexterity to processing micro/mini- samples, which may require quality eyesight or corrective lenses. + Ability to ensure the integrity of the studies and fulfill the regulatory agencies requirements by performing the activities according to the Good Laboratory Practices (GLP), Standard Operating Procedures (SOP), Business Operating Procedures (BOP) and the Institutional Animal Care and Use Committee (IACUC) rules. Comments + Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice. + Ability to work under specific time constraints. **About Safety Assessment** Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231865

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 Analyst I for our Analytical Chemistry Team at our Safety Assessment site located in Cleveland, OH. The analytical chemistry discipline is responsible for the analysis of dose formulations according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. The team develops and validates methods using a variety of instruments and platforms, with an emphasis on high performance liquid chromatography. The team assures that mixtures of test article with carrier are prepared at the proper concentration, are homogeneous, and are stable. In addition, the team is often involved in investigations and issues that are related to formulations and chemicals used on study. Essential Functions (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: * Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.) * Demonstrate effective communication skills through informal discussions with peers, supervisor, and team * Assist with laboratory maintenance functions * Independently perform laboratory support functions such as labeling and solution preparations * Assist with maintaining study specific inventory of consumables with oversight * Write both study and non-study deviations with minimal oversight * Actively participate in process improvement initiatives with oversight * Develop critical thinking, troubleshooting and time management skills aligned with needs of the operational area * Assist in execution of routine studies with oversight * Assist in execution of assay and/or method validation projects with oversight as needed * Operate laboratory instruments with complete oversight * Assist with data analysis in appropriate software for at least one platform * Performs all other related duties as assigned Job Qualifications Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: * Minimum of a Bachelor's degree (BA/BS) or equivalent experience. No previous work experience required * Ability to communicate verbally and in writing at all levels inside and outside the organization. * Basic familiarity with Microsoft Office Suite * Computer skills, commensurate with Essential Functions, including the ability to learn a validated system * Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice * Ability to work under specific time constraints The starting pay for this position is $21.00/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Must be authorized to work in the United States without a sponsor visa, now or in the future. About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly 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 *************** 230704