Charles River Labs jobs in Durham, NC

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** As an **Animal Care Associate** for our production site in **Raleigh, NC,** you will be responsible for the well-being of our research animals. Your contribution will ensure the health of our animals, as well as impact the lives of patients across the world. You will perform routine animal husbandry and other production duties. You will also maintain supplies and environment of environmentally-controlled work area(s). * This is a temporary opportunity with the potential to be hired as a full-time, employee. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Perform routine animal husbandry duties and monitor daily health and welfare to maintain quality and health of animals. + Handle, transfer, and distribute animals, supplies and waste as needed to and from work area(s). + Monitor animal health by observing animal behavior, physical appearance, and physical environment. Identify and report any abnormal findings. + Responsible for collecting health monitoring swabs and following health monitoring schedules. + Perform physical environment housekeeping duties and production operations according to Good Manufacturing Practices (GMPs) and/or Standard Operating Procedures (SOPs). + Maintain recordkeeping pertaining to animal or supply area inventories. + Strictly follow all procedures necessary to maintain the barrier room barrier. + Use supplies according to safety guidelines. Perform all job-related duties in accordance with company safety procedures. + Colony Management + Perform all other related duties as assigned. **MINIMUM QUALIFICATIONS:** No experience required. On the job training will be provided. **ROLE SPECIFIC INFORMATION:** + Location: Raleigh, NC + Pay: $17.75 - $19.00 / hour + Schedule: Start times fall between 4:00am - 6:00 am, working 9 hour shifts Monday - Thursday and a 4 hour shift on Friday. Weekend rotation is required. PHYSICAL DEMANDS + Regularly required to utilize a computer/tablet. + Regularly required to stand, use hands to finger, handle or feel objects, tools or controls; and reach with hands and arms. + Regularly required to stand and ascend/descend rolling platform ladder (up to six steps) to perform all tasks and procedures related to the job. + Regularly transports supplies, removes waste, and/or laboratory equipment while ascending/descending rolling platform stairs (up to six steps). + Regularly positions self (stoop, crouch, squat, sit, reach) to access and inspect small models and be able to assess their conditions and environment from various distances. + Regularly lifts and/or moves materials weighing up to 10 pounds and occasionally lifts and/or moves materials weighing up to 50 pounds. + May occasionally lift and/or move equipment and materials weighing 30-50 pounds, and equipment and materials weighing over 50 pounds with assistance. + Specific vision abilities required by this job include close vision, depth perception, and the ability to differentiate colors. + Regularly works with chemicals that require the use of respirators. Medical clearance is required prior to using respirators. _The pay range for this position is $17.75-$19.00 / hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location._ **About Research Models & Services** Fundamental to basic research and discovery is the use of in vivo models to help identify disease targets and determine potential biological pathways that regulate the condition. As the world's leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal models produced for preclinical research globally, we understand the importance of this step. With seven decades of experience, our expertise is unmatched, allowing us to provide you with the perfect model, including disease-specific and preconditioned options, for basic research and beyond. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231121

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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.

Join Novartis Gene Therapies as a Specialist, Quality Assurance - QC, where you'll ensure our products meet rigorous safety and quality standards. You'll oversee analytical method development, monitor lab performance, resolve testing issues, and support regulatory submissions- making a direct impact on patient outcomes. Location: Durham, NC #LI-Onsite Relocation Support: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible. Job Description Key Responsibilities Provide QA oversight for analytical method development, qualification, validation, and transfer. Monitor method and equipment performance for quality trends and standards adherence. Interpret characterization, product release, and stability data for decision-making. Support establishment and revision of drug substance and product specifications for regulatory submissions. Lead investigations and resolution of out‑of‑specification and out‑of‑trend testing results. Support invalid assay and aborted assay investigations. Ensure successful accomplishment of business goals through quality support. Support QC corrective and preventive actions (CAPAs) and change controls. Collaborate with laboratory teams to maintain compliance and reliability. Perform other related duties as assigned. Provide QA oversight of area with walkthroughs, logbook reviews and general QA oversite responsibilities Essential Requirements Bachelor's degree in scientific discipline. Minimum 5 years' experience in the biotechnology or pharmaceutical industry, which includes preferred experience in quality and/or compliance. At least 2 years directly supporting laboratory functions preferred. Strong knowledge of United States Pharmacopeia (USP), International Council for Harmonization (ICH), and European Pharmacopoeia (Ph. Eur.) regulations related to Quality Control. Experience implementing lean processes in Good Manufacturing Practice (GMP) lab or manufacturing environments. Excellent problem‑solving abilities. Strong technical writing skills. Ability to work independently, prioritize tasks, and deliver on tight timelines. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $39.03 and $72.50/hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $81,200.00 - $150,800.00 Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Are you ready to launch your career in a dynamic, fast-paced environment where learning and growth are part of the everyday experience? Parexel is seeking a proactive and detail-oriented Administrative Assistant to support our high-performing Sales team. This hybrid role at our new Headquarters in North Hills, NC (3 Days In-Office / 2 Days Remote after initial training period complete) offers exceptional exposure to our global business, meaningful collaboration, and the chance to make a real impact on our Business, and most importantly, to patients. What You'll Do Sales Support & Client Interface • Respond to unqualified leads and unsolicited inquiries via phone, mail, and website • Interface with clients to acknowledge proposals, establish timelines, and relay questions during proposal preparation • Coordinate proposal development, production, and delivery • Schedule and facilitate client meetings and teleconferences • Assemble and tailor sales support materials (e.g., therapeutic profiles, study-specific content) Administrative Responsibilities • Maintain and update CRM database with client interactions, study status, and revision requests • Track Confidentiality Agreements and Contracts in coordination with Business Operations • Organize proposal paperwork and maintain department/client files • Conduct research to support business development • Coordinate logistics for internal prep meetings and client-facing events • Manage travel arrangements, authorizations, and expense reports with precision and efficiency • Assist in the preparation of client facing sales PowerPoint presentations • Leverage prior experience with expense reporting software to create and manage accurate reports • Maintain daily calendar and schedules, ensuring seamless coordination across teams General Office Support • Provide general administrative and clerical support as needed What You Bring • Two to four years of previous administrative experience in a corporate setting • Proven experience managing and creating expense reports using dedicated software • Strong background in travel coordination and meeting logistics • Ability to multi-task and manage competing priorities with grace and efficiency • Exceptional attention to detail and organizational skills • Professional communication style with the ability to interface confidently with senior leaders, clients, and cross-functional teams • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) • Experience with CRM systems preferred • A collaborative spirit and eagerness to learn Why Parexel? At Parexel, you'll be part of a team that values innovation, integrity, and excellence. This role offers: • Exposure to global business operations • Hands-on learning and mentorship • A vibrant, supportive team culture #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. Job Title: Senior Data Modeler Job Introduction: At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking a Senior Data Modeler to define and develop logical and physical data models that satisfy PAREXEL's financial and operational reporting, analytic and integration needs. Who we are looking for: Curious individuals with previous experience working with data to contribute to the overall data models and define principles, designs, and models that drive information sharing across the enterprise. That possess excellent problem-solving and analytical skills while demonstrating impeccable communication skills. What you'll do: Partner with business subject matter experts and IT groups to document data attributes and requirements. Comprehend and translate business needs into data models which support long term solutions. Create logical and physical data models to support new and existing projects. Document logical and physical mapping definitions, data lineage and ETL requirements. Identify opportunities for standardizing data dictionaries, integration and archiving, and elimination of unnecessary redundancy. Help define robust design methodology, development process methodology and best practices. Additional details: 5+ years of experience with data warehouse development, with at least 1 year creating logical and physical dimensional, relational, and hierarchical data models. Experience modeling financial data and/or clinical data strongly preferred. Bachelors degree or equivalent experience required. Technology: ER/Studio, Oracle, Azure SQL, Azure Synapse, and Qlik Compose or other Data Warehouse Automation tools, Microsoft Azure PaaS (or similar cloud platforms), IaaS and related data and integration services, Azure Data Factory, DataBricks, PowerBI, and PowerApp. Why join us: Opportunity to work on innovative projects at the forefront of the industry. Collaborative and inclusive work environment that values your expertise. Professional advancement and development opportunities. Work life balance and flexible working hours. Parexel US Benefits: Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time Flexible Spending & Health Savings Accounts Work/Life Balance 401(k) with Company match Pet Insurance Full list of benefits available here: *********************************** About Parexel International: At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you're exposed to a world of experiences and open doors. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy, and we're committed to making a difference. If this job does not sound like the next step in your career, but perhaps you know of someone who would be a perfect fit, send them the link to apply! 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.

Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities: Oversees URS, protocols, reports & support records to ensure compliance, timely resolution of documentation, compliance, and quality system issues. Identify, coordinate, execute and provide oversight of validation activities related to the start-up, commissioning, qualification, validation of a cGMP manufacturing facility (including manufacturing equipment, QC lab equipment, utilities). Performs environmental mapping and other miscellaneous validation activities. Evaluates and analyzes validation data for accuracy and adequacy. Supports the development of validation execution strategy and timeline for sustained operation within validated GMP environment. Collaboratively conducts Risk Assessments and Impact assessments and establish system boundaries. Owns validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports. Reviews and supports Computer Systems Validation efforts for global systems. Manages workload to ensure timely approval of validation testing and documentation. Assists Quality Assurance, Production, Quality Control and other departments during inspections or audits. Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project. Other related duties as assigned. Requirements: BS/MS degree in Chemical, Industrial, Mechanical, or related engineering discipline; or Science with 5 years of relevant experience in the pharmaceutical or Biopharmaceutical industry (validation or engineering experience preferred).. Experience with Biosafety cabinet smoke studies. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Experience supporting FDA approved, commercial products. Experience in cGMP environment (IQ, OQ, PQ) is essential. Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects. Experience with validation tools and processes, including environmental mapping and use of Kaye Validator. Familiar with GAMP 5 applications and practices. Excellent technical writing and verbal communication skills. Proficient in Microsoft Word, Excel, PowerPoint, and Project. Experience providing technical support for problems of moderate scope where analysis requires a review of a variety of factors and able to drive toward issue resolution. Skills: Business Continuity. Change Control. Flexibility. General Hse Knowledge. Hvac (Heating Ventilation And Air Conditioning). Including Gdp. Installations (Computer Programs). Knowledge Of Capa. Knowledge Of Gmp. Manufacturing (Production). Project Commissioning. Project Engineering. Project Execution. Risk Management. Root Cause Analysis (Rca). Languages: English Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $89,600.00 - $166,400.00 Skills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

**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.

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.

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.

**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.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. Job Title: Integration Engineer Job Introduction: At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an Integration Engineer to build and support APIs, data integrations, and automation solutions that drive innovation in clinical trials. This is a fantastic opportunity to develop your skills in a collaborative, mission-driven environment while contributing to real-world healthcare solutions. Who we are looking for: This role is ideal for recent graduates with strong technical foundations or developers with up to 2 years of experience in integration platforms like MuleSoft that are eager to learn and grow within the role. That possess excellent problem-solving and analytical skills while demonstrating impeccable communication skills. What you'll do: Assist in designing and developing integration solutions using MuleSoft Anypoint Platform, Azure Logic Apps, Python or similar tools. Build and maintain RESTful APIs and integration flows for clinical trial systems and data platforms. Support the development and testing of connectors and automation scripts using Python or Java. Help troubleshoot integration issues and contribute to support efforts for ongoing clinical studies. Participate in code reviews, documentation, and continuous improvement initiatives. Stay curious and up to date on emerging technologies in AI, APIs, and integration platforms. Additional details: Hands-on experience with MuleSoft, CoPilot Studio, Logic Apps or other integration platforms (training, support, or development) is preferred. Experience building or maintaining APIs and integration flows, exposure to cloud platforms (AWS, Azure, or GCP) is a plus, understanding of Agile/Scrum development practices is ideal. Bachelor's degree in Computer Science, Information Technology, or a related field is required. Why join us: Opportunity to work on innovative projects at the forefront of the industry. Collaborative and inclusive work environment that values your expertise. Professional advancement and development opportunities. Work life balance and flexible working hours. Parexel US Benefits: Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time Flexible Spending & Health Savings Accounts Work/Life Balance 401(k) with Company match Pet Insurance Full list of benefits available here: *********************************** About Parexel International: At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you're exposed to a world of experiences and open doors. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy, and we're committed to making a difference. If this job does not sound like the next step in your career, but perhaps you know of someone who would be a perfect fit, send them the link to apply! EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Company Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. Position Brand Description: The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program. The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to: * Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally. * Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. * Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. * Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. * Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics. * Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. * Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. * Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. * Actively collaborate with enterprise-wide teams on standardized global business processes. * As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. * Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management. * Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique Basic Requirements: * 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing * 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment. * Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. * Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management. * Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation) * Strong written and oral communication skills * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals * Approximately 25% travel Additional Preferences: * Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control. * Experience leading a major multi-site or global functions improvement initiative. * Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. * Proficiency in addressing operational challenges through structured approaches and innovative solutions. * Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. * Demonstrated change agility in anticipating and leading others through change and ambiguity. * Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. * Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. * Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. * Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. * Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. * Demonstrated people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major multisite improvement initiative or driving multisite standardization. * Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training. * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Education Requirements: BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. Job Title: Internal Audit Job Introduction: At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an Internal Auditor to assist with risk assessment and audit scoping and planning for internal controls over financial reporting. Who we are looking for: Detailed individuals with previous experience in public accounting, corporate finance/accounting and/or internal audit. That possess excellent problem-solving and analytical skills while demonstrating impeccable communication skills. What you'll do: Execute internal controls testing to accurately document design and operate effective conclusions Assist with risk assessment and audit scoping/planning across a variety of functional areas including operational risk and compliance audits Prepare audit workpapers that are thorough, complete, and accurate Interact with management to build strong, trust-based ongoing relationships Partner with Control and Process Owners to establish, maintain, and strengthen the global control environment Additional details: 1-3 years' experience in public accounting, corporate finance/accounting and/or internal audit. Experience with internal controls testing is required; experience with operational audits and/or IT audits is a plus. Bachelor's degree or higher in Accounting or Finance required. Certified Public Accountant (CPA) or other relevant certification such as Certified Internal Auditor (CIA) strongly preferred. Why join us: Opportunity to work on innovative projects at the forefront of the industry. Collaborative and inclusive work environment that values your expertise. Professional advancement and development opportunities. Work life balance and flexible working hours. Parexel US Benefits: Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time Flexible Spending & Health Savings Accounts Work/Life Balance 401(k) with Company match Pet Insurance Full list of benefits available here: *********************************** About Parexel International: At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you're exposed to a world of experiences and open doors. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy, and we're committed to making a difference. If this job does not sound like the next step in your career, but perhaps you know of someone who would be a perfect fit, send them the link to apply! EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

We are looking to fill a **Scientist 3 - 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.

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 As a Senior Technologist / Team Lead in Raleigh, NC, you will provide daily direction and operational guidance to ensure achievement of departmental goals and communicate progress to supervisor. You will perform specialized production duties to maintain and monitor the health, production and physical environment of animals within isolators, micro-isolator cages or barrier rooms. You will provide training to departmental staff on all technical skills and Standard Operating Procedures (SOPs). You will act as team leader for designated area(s). ESSENTIAL DUTIES AND RESPONSIBILITIES * Provide daily direction, schedule, prioritize workload and review work of assigned group to ensure accuracy and adherence to pertinent departmental policies, SOPs, safety procedures and biosecurity protocols. * Provide leadership and motivation to departmental personnel. * Assist in ensuring optimum performance of group function. May recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices. * Coordination and scheduling of activities of the assigned group through hands-on technical support and delegation * Act as team leader for designated area, perform specific departmental projects, and coordinate other operations staff as directed. * Coordinate production and shipping activities of assigned group, including SOPs and OORs. Assist in the performance of production and shipping activities as necessary. * Responsible for complying with all SOPs pertaining to specific area. Provide input into the creation and revision of SOPs and assist with the implementation and training of new SOPs. * Perform specialized duties in the following areas: packing and shipping animals to customer; performing value added services; biospecimen orders and introducing supplies. * Perform production duties, ensuring proper breeding procedures and maintaining appropriate levels of assigned specialized rodent breeds, including inbred and outbred strains. * Monitor animal health by observing animal behavior, physical appearance, and physical environment. Identify and report any abnormal findings. Monitor animal health visually and by swabbing. * Monitor performance of team-members and provide daily feedback to supervisor. Assist with follow thru of disciplinary and personnel related concerns. * Assist with training and development of departmental staff on all levels of animal husbandry, production and tasks including feeding, watering and cleaning cages as required. * Assist with training and development of departmental staff on specialized tasks in the following areas; packing and shipping animals to customer; providing technical training to departmental personnel; performing value added services, biospecimen orders and introducing supplies. * Responsible for collecting health monitoring swabs and following health monitoring schedules. * Maintain the biosecurity of the animal physical environment by following SOPs related to introduction and removal of supplies/animals, isolator inspection and supply inspections. * Assist in the maintenance of physical environment, departmental equipment, and biosecurity in accordance with SOPs. Communicate findings and concerns to supervisor. * Maintain accurate departmental and isolator records. * Lead the preparation of reports, order inquiries, and completion of customer paperwork. Communicate with Customer Service department as needed. * Perform general housekeeping, adhere to safety procedures and follow ergonomic practices and stretching schedule. * Perform all other related duties as assigned. MINIMUM QUALIFICATIONS Candidates must possess one of the following: * Bachelor's in life sciences or related discipline and 1 year of demonstrated leadership responsibilities. * Associates degree in life sciences or related discipline and 2 years of demonstrated leadership responsibilities. * High school diploma or GED and 3 years of demonstrated leadership responsibilities. ADDITIONAL QUALIFICATIONS: * Effective communication and interpersonal skills. * Demonstrated computer skills (data input, word processing). PREFERRED QUALIFICATIONS: * ALAT certification Salary Transparency The pay range for this position is $22.00 - $32.00 / hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Research Models & Services Fundamental to basic research and discovery is the use of in vivo models to help identify disease targets and determine potential biological pathways that regulate the condition. As the world's leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal models produced for preclinical research globally, we understand the importance of this step. With seven decades of experience, our expertise is unmatched, allowing us to provide you with the perfect model, including disease-specific and preconditioned options, for basic research and beyond. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 229709

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. Job Title: Financial Analyst II - Project Finance Job Introduction: At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking a Financial Analyst II to establish themselves as a “co-pilot”, along with the Project Leader (PL), in steering a set of projects to their targeted financial goals (e.g. revenue, profitability, cash flow, etc.). The main success factors of this role include strong business acumen, strong grasp of project operations and their implications for financial performance, and strong technical, analytical, and consulting skills. Who we are looking for: Driven individuals with proven experience working as a Financial Analyst or in a similar role. Who are passionate and knowledgeable of project finance with an understanding of project/proposal deliverables. That have strong analytical and consulting skills along with excellent problem-solving skills while demonstrating impeccable communication skills. What you'll do: Create accurate, transparent, and timely financial analysis to support project leadership in project decision making process; clearly articulate financial implications of business decisions and provide retrospective analysis as well as drive forward looking actions on simpler projects / contract types. Facilitate the monthly revenue cycle and support project analysis requirements, including a review of units, forecast, unit prices, and revenue recognition. Complete all required variance analyses for the set of projects, with insight. Identify risks in the project forecast and opportunities to improve revenue outlook. Communicate, document, and manage these on an ongoing message. Understand alternative finance scenarios within a project with a degree of technical knowledge and business acumen. Provide updates on financial status for assigned projects and create information in response to any client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio. Actively monitor the balance sheet positions of projects within the portfolio. Initiate action as needed with project teams to keep balances current, improving DSO and cash flow. Additional details: 3+ years' experience as a project financial analyst required. An understanding of the fundamentals of CRO industry and how Finance's role influences in the organization is a plus. Proficient with Excel and PowerPoint applications; experience with financial performance systems. Passion to succeed, demonstrated problem solving skills, and professionalism. Bachelor's Degree and/or equivalent experience required in Finance/Accounting. Why join us: Opportunity to work on innovative projects at the forefront of the industry. Collaborative and inclusive work environment that values your expertise. Professional advancement and development opportunities. Work life balance and flexible working hours. Parexel US Benefits: Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time Flexible Spending & Health Savings Accounts Work/Life Balance 401(k) with Company match Pet Insurance Full list of benefits available here: *********************************** About Parexel International: At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you're exposed to a world of experiences and open doors. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy, and we're committed to making a difference. If this job does not sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, please share the job posting link to apply! EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: + Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project management skills with a track record of managing complex projects and meeting deadlines. + Excellent organizational and communication skills. + Excellent time management abilities + Proficient in Microsoft Office Suite + Proven experience with project management software ie. Smartsheet + Strong communication and interpersonal skills + Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: + Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.