Charles River Labs jobs in Reno, NV

- 23 jobs

Senior Clinical Veterinarian
Charles River Laboratories 4.3
Charles River Laboratories job in Reno, NV
At Charles River, we are passionate about improving the quality of people's lives. When you join our global family, you will help create healthier lives for millions of patients and their families. Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe. **Job Summary** Oversee and perform veterinary procedures that support all studies. Assist the Director in oversight of the animal care and use program. May supervise or oversee veterinary staff and manage the activities of assigned section to ensure effective performance. ESSENTIAL DUTIES AND RESPONSIBILITES: + Manage health care for the animals within the facility. + Perform veterinary rounds as scheduled and provide clinical care and preventive medicine support. + Perform advanced diagnostics and interpret results: ultrasounds, EKG, ophthalmology exams. + Perform and/or assist with clinically necessary surgery and anesthesia (review & refine anesthesia/analgesia protocols, perform minor surgery and anesthesia). + Perform minor and major study-related procedures/surgeries as needed (e.g. biopsies, telemetry, vascular access ports). + Perform regular trend analysis of health cases and provides follow up root cause analysis and CAPA for patterns identified. + Provide emergency care (all species), including on call emergency duties. + Perform euthanasia. + Perform physical exams, neurologic, and ophthalmic exams for study/colony support. + Review & draft SOPs or BOPs. + Oversee management/review of controlled substances log. + Participate in IACUC semi-annual inspections. + Can serve as voting IACUC member and designated reviewer (where applicable). + Lead client visits (in absence of the Attending Veterinarian) & regulatory visits. + Support preparation of documents and assists Attending Veterinarian (AV) with regulatory agency site visits. + Sign health certificates/shipping documents. + Lead biosecurity and/or animal welfare program, assessment, root cause analysis & CAPA + Collaborate with teams to lead implementation of animal care program refinements. + Assist Scientists/Study Directors with animal health and care questions from clients. + Act as Study Director for internal colonies (holding, training, internal projects, etc.). + Develop study intervention plans. + Train trainers and/or provide oversight of training program for staff (handling, injection, sampling techniques, sterile technique, surgical procedures, anesthesia & anesthesia monitoring. + Assist with continuing education of staff through providing didactic or practical training to reinforce or improve knowledge and skills. + Contribute to training and development of junior veterinarians. + Develop and contribute to training on research techniques and other aspects of vivarium education. + Consult directly with clients. + Understand the 3Rs and advise on their use & application. + Consult with internal and external clients, sponsors, consultants and external contractors regarding veterinary care program, health monitoring and model quality (as necessary). + Assist with data collection/analysis for R&D studies/projects and/or animal welfare concerns. + Lead research & development studies or pilot new techniques. + Contribute to the design and delivery of projects leading to presentations or publishing opportunities. + Have specialty expertise or certification in a specific discipline (ex. biosecurity, ophthalmology, cardiology, laboratory animal medicine, animal welfare, etc.). + Regional responsibilities and enterprise travel. **Job Qualifications** MINIMUM QUALIFICATIONS: + Education: Veterinary degree (D.V.M./V.M.D.) or international equivalent. + Experience: Minimum of 5 years of experience in LAM relevant area/education and/or 10 years of experience in veterinary medicine. + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + Certification/Licensure: Licensure to practice veterinary medicine in at least one U.S. state required. Must be able to maintain current licensure/certification. + Other: Computer literacy (Windows PC) WordPerfect and Excel. Good communication, interpersonal, and organizational skills. Knowledge of laws, regulations, policies and guidelines that govern animal research, research conduct principles (GLP) and current methodology of laboratory animal medicine and management is important. PREFERRED QUALIFICATIONS: + Experience: Two years supervisory/ management experience preferred. + Certification/Licensure: Ability to practice veterinary medicine in the work state highly desirable. ACLAM eligibility or accreditation is highly desired. Compensation Data The salary for this opportunity is $190,000 - $215,000 USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Note: Relocation assistance (if necessary), sign-on bonus and a retention bonus will be part of the overall compensation package as well. **About Safety Assessment** Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in 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 *************** 231004
$190k-215k yearly Easy Apply 45d ago
Clinical Veterinarian I
Charles River Laboratories 4.3
Charles River Laboratories job in Reno, NV
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 providing professional veterinary services. Oversee and perform veterinary procedures that support all studies. Oversee all aspects of the animal care and use program as needed. May supervise or oversee veterinary technicians and manage the activities of assigned section to ensure effective performance. ESSENTIAL DUTIES AND RESPONSIBILITIES: + Manage health care for the animals within the facility. + Perform veterinary rounds as scheduled and provide clinical care and preventive medicine support. + Perform basic diagnostics and interpret results: CBC, chemistry, radiographs, EKG. + Perform and/or assist with clinically necessary surgery and anesthesia (review & refine anesthesia/analgesia protocols, perform minor surgery and anesthesia). + Provide emergency care (all species), including on call emergency duties. + Perform euthanasia. + Perform physical exams (at client request). + Perform minor study procedures or low-risk surgeries (ex. biopsies). + Perform veterinary reviews for protocols. + Oversee management/review of controlled substances log. + Participate in IACUC semi-annual inspections. + Sign health certificates/shipping documents. + Maintain continuing education (CE) & licensure. + Assist behaviorist (socialization, behavioral assessments, environmental enrichment program development, habituation). + Adhere to biosecurity program requirements. + Propose animal care program refinements. + Train trainers and/or provide oversight of training program for staff (handling, injection, sampling techniques, sterile technique, surgical procedures, anesthesia & anesthesia monitoring. + Assist Scientists/Study Directors with animal health and care questions from clients. + Assist with data collection/analysis for R&D studies/projects and/or animal welfare concerns. **Job Qualifications** + Education: Veterinary degree (D.V.M./V.M.D.) or international equivalent. + Experience: Zero to two years related experience with animal care and surgical techniques. Experience in a research/lab animal/GLP environment preferred, but not 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: Must be licensed in country, province or state of employment to fulfill requirements to practice veterinary medicine, and sign health certificates. Must be able to maintain current licensure/certification. + Other: Computer literacy (Windows PC) WordPerfect and Excel. Good communication, interpersonal, and organizational skills. Knowledge of laws, regulations, policies and guidelines that govern animal research, research conduct principles (GLP) and current methodology of laboratory animal medicine and management is important. + Physical Demands: While performing the duties of this job, the employee is regularly required to stand, crouch, bend, climb, reach overhead, kneel, push/pull and use hands to manipulate objects of varying size and with varying degrees of precision. While performing the duties of this job, the employee is regularly required to discern animal health and well-being through visual and physical assessment. Employees must be able to lift, move and/or hold up to 40 pounds; this includes equipment and animals. Compensation Data The pay range for this position is $150,000 or more DOE. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Note: Relocation assistance (if necessary), sign-on bonus and a retention bonus will be part of the overall compensation package as well. **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 *************** 230985
$150k yearly Easy Apply 45d ago
Regulatory Affairs Consultant - Labeling Operations
Parexel 4.5
Carson City, NV job
Join us as a **Global Labeling Operations Manager** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global markets. In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely, and high-quality labeling updates. This is a unique opportunity to work on diverse programs, including pandemic products and flu campaigns, while contributing to the governance, compliance, and strategy of global labeling. Key Responsibilities: - Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership. - Coordinate readability testing (planning, team review, and communications) - Oversee translations for foundational markets (EU, CH, DE). - Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL). - Upload approved labels to internal systems (Documentum, Weblabel, intranet). - Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders. - Lead impact assessments for technical and global labeling changes across dependent markets. - Perform data entry in Trackwise/Veeva and prepare annual labeling reports. - Review and update submission content plans; prepare change control documentation for CCDS-driven changes. - Prepare and manage Structured Product Labeling (SPL). - Support advertising and promotional and marketing material reviews, educational materials, and social media compliance. - Ensure compliance with country-specific regulatory requirements. - Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: - University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. - Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility. - Experience leading teams in a matrix organization. - Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. - Experience with flu campaigns, pandemic products, and direct-to-consumer advertising. - Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems. - Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS. Competencies: - Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing. - Strong problem-solving skills with the ability to analyze risk and recommend solutions. - Effective communicator, able to explain complex concepts and influence cross-functional colleagues. - Excellent organizational skills with attention to detail and strategic thinking. - Ability to thrive in complex, matrixed, and cross-cultural environments. - Fluency in English (verbal and written); additional languages a plus. Why Join Us: - Work on impactful global programs that directly support patient safety and regulatory compliance. - Collaborate with a diverse, international team across multiple therapeutic areas. - Gain exposure to advanced regulatory systems and global labeling strategies. - Competitive compensation, benefits, and opportunities for career growth. If you're passionate about global labeling operations and ready to make a difference in patient safety worldwide, we'd love to hear from you. \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$78k-98k yearly est. 3d ago
Data Management Lead
Parexel 4.5
Carson City, NV job
**Job Title:** Data Management Lead (Medical Affairs) - Oncology **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. \#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.
$79k-117k yearly est. 60d+ ago
Medical Director - Ophthalmology
Parexel 4.5
Carson City, NV job
**Parexel** is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. **Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global Medical Sciences team.** **The role can be based remo** t **ely in the US or Canada.** The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians. Primary activities will focus on **Medical Monitoring Delivery & PV Support** . The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician). **Medical Expertise** and experience in **Ophthalmology** is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc. **Client Relationship Building & Engagement,** including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor. **Business Development:** the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings. **Skills** + Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts + Client-focused approach to work + Excellent time management skills + Excellent verbal and written medical communication skills + Excellent standard of written and spoken English + A flexible attitude with respect to work assignments and new learning + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail + Willingness to work in a matrix environment and to value the importance of teamwork. **Knowledge And Experience** + Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in **Ophthalmology** , which is expected to be kept up to date. + A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred + Clinical practice experience + Good knowledge of the drug development process including drug safety, preferred + Experience in Pharmaceutical Medicine, preferred + Experience leading, mentoring and managing individuals/ a team, preferred **Education** + US Board certified in **Ophthalmology** or Canadian equivalent + Experience as a Physician in Industry or as a clinical trial investigator is required + Previous CRO experience is strongly preferred + Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship) The ability to travel 15% domestically or internationally is required \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$211k-294k yearly est. 23d ago
Senior Medical Writer- FSP
Parexel 4.5
Carson City, NV job
The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$78k-111k yearly est. 3d ago
Research Scientist I - Bioanalytical Science
Charles River Laboratories 4.3
Charles River Laboratories job in Reno, NV
For 70 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 **Research Scientist (Bioanalytical)** for our Safety Assessment site located in Reno, NV. Serve as a scientist in the conduct of assigned preclinical and clinical research studies of basic to moderate complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects. We are seeking a **Research Scientist I (Bioanalytical)** for our Safety Assessment site located in Reno, NV. This position will serve as a scientist in the conduct of assigned nonclinical and clinical bioanalytical studies at all levels of complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include serving as a primary scientific contact for key clients and the on-site support of their programs, as well as the support of specialty studies. The ideal candidate will have experience with design and optimization of ligand binding assays including ELISA, MSD, or Gyrolab platforms. * Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or PhD preferred. * Minimum of 3 to 5 years related experience in the contract research, academic, or pharmaceutical industry. * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. * Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. * Effective written and verbal communication skills. * Ability to handle multiple projects, prioritize work and meet deadlines. * Proficiency in the use of standard software including Microsoft Excel, Word, Powerpoint, etc. and with standard laboratory calculations. The pay range for this position is $90,000 to $95,000 annually USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location 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 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion. 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 ~85% of the drugs approved by the FDA in 2019. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet. 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 *************** 231434
$90k-95k yearly Easy Apply 4d ago
Research Analyst I - Bioanalytical Sciences
Charles River Laboratories 4.3
Charles River Laboratories job in Reno, NV
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 **Safety Assessment** site located in **Reno, NV** . This position will be responsible for handling and processing samples and performing accurate data collection and reporting. Basic methods will be used to perform laboratory tasks with minimal supervision in the performance of studies. **Job Qualifications** The following are minimum requirements related to the Research Analyst 1 position. + Associate's degree (A.A. / A.S) or equivalent in biological science or related discipline required. Bachelor's degree (B.A. / B.S.) preferred. + 6 Months minimum related experience in biology, chemistry/pharmacy, or similar lab environment GLP experience preferred. + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + Proficient in basic technical skills and the operation of data collection equipment. + Knowledge of GLPs and other federal regulations and guidelines. + Basic understanding of study design and protocols; able to read basic study protocols and extract pertinent information. + Must be able to perform effectively as a team member, accurately record data, follow verbal and written instructions, communicate effectively, and interact in a professional manner with management, coworkers, and sponsors. + Able to quickly learn and utilize computer programs as needed. The pay for this position starts at $24/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Schedule is M-F, 9-5 w/30 min lunch or M-F, 8-5 w/1 hr lunch. **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 *************** 230949
$24 hourly Easy Apply 13d ago
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Parexel 4.5
Carson City, NV job
**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#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.
$86k-116k yearly est. 9d ago
Scientist III - Analytical Chemist - FSP
Parexel 4.5
Carson City, NV job
We are looking to fill a **Scientist 3 - Analytical Chemist** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Responsibilities** + General understanding of analytical method development and method validation + Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques + General knowledge of separations science + Experience with Empower chromatographic software and with analysis of drug formulations + Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis + Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems **Required Skills** + Strong computer, scientific, and organizational skills + Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation + Excellent communication (oral and written) and attention to detail + Proficient in written and spoken English, is required **Desired Skills and Experience** + Empower software + Analysis of drug products + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude **Qualifications** + BS degree and 3-5 years of relevant experience, or + MS degree with at least 1-2 years relevant experience **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$68k-94k yearly est. 60d+ ago
Associate Project Delivery Lead Real World Research
Parexel 4.5
Carson City, NV job
**Title: Principal Real World Research Delivery Lead (RWRDL)** Are you ready to take on a challenge and accelerate your career? This is an **excellent opportunity for a self-driven, autonomous leader** eager for growth and progression. Parexel is seeking a **Principal Real World Research Delivery Lead (RWRDL)** to join our team and deliver innovative Real World Research (RWR) solutions for global clients. This is a great opportunity to join our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll **lead cross-functional teams** , manage **budgets and timelines** , and serve as the **primary client contact** for innovative RWD projects. We're looking for a **strategic project leader** with strong communication skills, adaptability, and a go-getter mindset. Experience in **RWD/RWE** , **data privacy** , and **drug development** is a plus. **Career Growth:** Shape new services, mentor emerging leaders, and gain visibility in a lean PM model. As a senior leader, you will: + **Lead cross-functional teams** and act as the primary client contact for complex RWR and RWD projects. + Oversee **project proposals, budgets, timelines, and milestones** while ensuring compliance with SOPs and data privacy standards. + Collaborate with multidisciplinary teams to design and implement RWR-enabled solutions. + Mentor junior team members and help shape new services in a lean PM model. **What We're Looking For:** + Strong **project leadership experience** with proven ability to manage multiple projects and decentralized teams. + Excellent **communication skills** , adaptability, and a proactive, go-getter mindset. + Knowledge of **RWD/RWE methodologies** , data privacy, and drug development processes. + Ability to thrive in dynamic environments and lead independently. **Preferred Experience:** + RWD/RWE expertise, commercial experience, and familiarity with late-phase clinical research. + Understanding of RWD platforms, project management systems, and GCP environments. **Education:** Bachelor's degree in a science or clinical-related field; Prince II or AMPM certification preferred. **Why Join Us?** + **Career progression** and visibility in a growing RWD space. + Opportunity to **develop new services and mentor emerging leaders** . + Work on impactful projects that shape the future of clinical research. If you're ambitious, adaptable, and ready to make a difference, **apply today and lead the way in Real World Research!** \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$98k-149k yearly est. 3d ago
Regulatory CMC Project Manager
Parexel 4.5
Carson City, NV job
If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: + Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project management skills with a track record of managing complex projects and meeting deadlines. + Excellent organizational and communication skills. + Excellent time management abilities + Proficient in Microsoft Office Suite + Proven experience with project management software ie. Smartsheet + Strong communication and interpersonal skills + Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: + Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$75k-110k yearly est. 4d ago
Medical Technologist I
Charles River Laboratories 4.3
Charles River Laboratories job in Reno, NV
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** **BASIC SUMMARY:** Perform basic medical technology procedures according to protocol, SOP and GLP. Operate, maintain and perform basic troubleshooting procedures on analyzers. Process additional study samples. Perform and review study ordered parameters and computer input of raw data. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** * Assist in the preparation of appropriate paperwork and materials prior to clinical pathology blood collection days. Assist with the computer protocol work schedule for each study, as needed. * Perform basic medical technology procedures such as record blood slide differentials, reticulocyte counts, and urinalysis with minimal supervision; prepare blood and cytology slide smears. * Inventory and package differential and reticulocyte blood slides for each study for shipment or storage. * Maintain proficient knowledge of hematology, clinical chemistry, coagulation, and urinalysis. * Analyze proficiency survey samples. * Review documentation of functions performed as part of quality requirements. * Input raw data into the computer system and review data. * Operate, maintain, and troubleshoot clinical pathology analyzers. * Perform daily maintenance and quality control of instruments. * Perform all other related duties as assigned. **Job Qualifications** + _Education:_ Associate's degree (A.A./A.S.) or equivalent in medical laboratory technology (MLT) or related field required. Bachelor's degree (B.A./B.S.) or equivalent in medical technology (MT) desired. + _Experience:_ 2-3 years of experience in a clinical pathology laboratory. + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + _Certification/Licensure:_ MT or MLT with certification or certification-eligible (ASCP or HEW) preferred. + _Other:_ Experience with computer software programs is desirable. Effective organizational and leadership skills desired. The pay range for this position is $30.00-32.00 an hour. **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 *************** 230143
$30-32 hourly Easy Apply 45d ago
CMC Regulatory Affairs Senior/Consultant - Small Molecules
Parexel 4.5
Carson City, NV job
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access. Key Responsibilities Strategic CMC Leadership - Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios - Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads Submission & Documentation Excellence - Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions - Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes Cross-Functional Collaboration - Partner with manufacturing, quality, and external organizations to address CMC-related issues - Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers - Support planning and execution of Health Authority meetings, including mock sessions Process Optimization & Innovation - Identify and implement process improvements to enhance regulatory efficiency and readiness - Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions - Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer Regulatory Systems & Reporting - Experience with CPP application filing via eCATS and 510(j)(3) reporting through next Gen portals is a plus - Ensure audit readiness and version control through meticulous documentation and system management Qualifications Experience & Expertise - 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF) - In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus! Skills & Attributes - Strategic and proactive mindset with strong operational execution - Excellent analytical, problem-solving, and negotiation skills - Effective communicator with strong interpersonal, presentation, and leadership abilities - Ability to manage multiple projects independently in a matrixed, multicultural environment - Proficiency in Microsoft Office Suite and regulatory systems Education - Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field - Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred - RAC certification is a plus Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed. \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$84k-110k yearly est. 60d+ ago
Senior Medical Writer - US - FSP
Parexel 4.5
Carson City, NV job
The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#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.
$78k-111k yearly est. 3d ago
Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience - FSP
Parexel 4.5
Carson City, NV job
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.
$80k-114k yearly est. 32d ago
Veterinary Technician Assistant II
Charles River Laboratories 4.3
Charles River Laboratories job in Reno, NV
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 Veterinary Technician Assistant II for our Safety Assessment site located in Reno, Nevada. The Veterinary Technician Assistant II will be responsible for surgical technical duties, intermediate and advanced surgical procedures. BASIC SUMMARY: Responsible for assisting the veterinary staff in the documentation and management of all laboratory animal health cases. Also responsible for daily heath observations, preventive health care, environmental enrichment and handling and restraint of laboratory animals. ESSENTIAL DUTIES AND RESPONSIBILITIES: + Perform and be proficient in basic veterinary technical skills (i.e. treatments, collection of biological samples, TB tests, veterinary observations, etc). + Provide environmental enrichment for laboratory animals according to facility and Federal guidelines. + Perform animal follow-up observations as required. + Monitor animal heath, visually and by following detailed schedules. + Generate animal treatment records and perform, track and schedule follow-ups. + Assist in keeping inventory and stocking the vet rooms (i.e. drugs and supplies). Assist in organizing and maintaining the vet exam rooms. + Clean animal areas, transports animals and maintains related equipment. + Record keeping of required logs. + Observe animals and reports apparent abnormalities. + Sanitize cages and other related equipment as may be required. + Administer basic veterinary treatments to include IM injections, SC., etc. + Perform routine preventive health care skills including nail/teeth clipping/trimming, ear exams and dental exams. + Measure and distribute feed to laboratory animals in accordance with established procedures for facility. + Perform quarantine and isolation procedures as required. + Perform duties associated in the receipt, transferring and shipment of animals. + Perform all other related duties as assigned. **Job Qualifications** QUALIFICATIONS: + _Education:_ High school diploma or General Education Degree (G.E.D.). + _Experience:_ 1-2 years related experience in a laboratory animal facility. + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + _Certification/Licensure:_ ALAT preferred The pay range for this position starts at $22.00 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **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 *************** 231127
$22 hourly Easy Apply 27d ago
Senior Clinical Research Associate - West Coast - Oncology - FSP
Parexel 4.5
Carson City, NV job
The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$86k-116k yearly est. 13d ago
Senior / Regulatory Affairs Consultant - Advertising and Promotion
Parexel 4.5
Carson City, NV job
We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust. Key Responsibilities - Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content. - Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development. - Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. - Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements. - Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. - Support preparation of responses to regulatory inquiries related to promotional activities. - Track and manage promotional submissions and approvals in regulatory systems - Manage SOPs and electronic review systems. Qualifications - Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field. Experience: - 3-5 years of pharmaceutical/biotech related industry experience. - Direct experience in advertising and promotional regulatory review. - Familiarity with FDA regulations governing promotional materials. Skills: - Strong organizational skills with the ability to manage multiple projects under tight timelines. - Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners. - Attention to detail combined with strategic thinking. - Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS). - Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards. Competencies: - Knowledge of US regulatory requirements for advertising and promotion. - Demonstrated problem-solving ability and sound decision-making. - Ability to work effectively in a matrix environment and collaborate across diverse teams. - Strong interpersonal skills with cross-cultural awareness. - Fluency in English (verbal and written). \#LI-LB1 \#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.
$84k-110k yearly est. 3d ago
Scientist II or III - Analytical Chemist Metrology Specialist
Parexel 4.5
Carson City, NV job
We are looking to fill a **Scientist II or III - Metrology Specialist** position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer sponsorship.** **Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment** . This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement **Qualifications -** B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline + **Scientist II** - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience + **Scientist III** - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience **Responsibilities** + Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation + Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships + Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded equipment or software packages + Support the purchase, installation, and equipment qualification of new laboratory equipment + Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support + Originate and progress Notice of Event (NOE) and Change Management (CM) records + Perform and document investigations and assist in developing/implementing CAPA plans + Represent the laboratory on all aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and Experience** + Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks + Capable of working independently under moderate supervision + Strong verbal and written communication skills + Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators **Desired Skills and Experience** + Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. + Experience with computerized standalone systems GMP validation requirements + Familiarity with authoring relevant instrument standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$68k-94k yearly est. 39d ago

Charles River Labs jobs in Reno, NV

Senior Clinical Veterinarian

Clinical Veterinarian I

Regulatory Affairs Consultant - Labeling Operations

Data Management Lead

Medical Director - Ophthalmology

Senior Medical Writer- FSP

Research Scientist I - Bioanalytical Science

Research Analyst I - Bioanalytical Sciences

Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP

Scientist III - Analytical Chemist - FSP

Associate Project Delivery Lead Real World Research

Regulatory CMC Project Manager

Medical Technologist I

CMC Regulatory Affairs Senior/Consultant - Small Molecules

Senior Medical Writer - US - FSP

Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience - FSP

Veterinary Technician Assistant II

Senior Clinical Research Associate - West Coast - Oncology - FSP

Senior / Regulatory Affairs Consultant - Advertising and Promotion

Scientist II or III - Analytical Chemist Metrology Specialist

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