Catalent Pharma Solutions jobs in Winchester, KY - 38 jobs

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Pharmaceutical Technician is primarily responsible for the manufacturing of pharmaceutical product per established specifications. They will perform all the basic tasks relating to weighing, transferring, mixing, and processing of raw material to create a finished good. The Pharmaceutical Technician is also responsible for a variety of support activities, such as cleaning of production rooms, corridors, and equipment. All responsibilities are dictated by strict regulations (e.g., cGMP, SOP, batch records). Shift: B/D Shift (6 PM-6 AM 2-2-3 schedule). This role is 100% on-site in Winchester, Kentucky. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Role Understand and follow all environment, health, and safety requirements; in particular, personal protective equipment (PPE) requirements and understand and follow all current Good Manufacturing Practices regulations (cGMP), applicable standard operating procedures (SOP), and executed batch records. Complete all required training and qualifications regarding the role in a timely manner; in particular, ComplianceWire assignments. Weigh and transfer materials using calibrated scales and balances, utilize hand tools to assemble and disassemble various types of machinery and perform basic calculations with aid of a calculator. Accurately complete all applicable documentation pertaining to completed tasks; in particular, batch records, forms, and cleaning records. Perform detailed cleaning of manufacturing suites and equipment using various cleaning solutions and in accordance with cleaning records and maintain a work environment that is clean, organized, and audit-ready. Cooperate seamlessly with coworkers, Room Leader, Functional Leader, and Production Supervisor and perform all tasks within a team as assigned by Room Leader, Functional Leader, and Supervisor. Interact with customers and visitors in a highly professional manner at all times. Other duties as assigned. The Candidate High School Diploma or Equivalent Required. Prior experience working in a pharmaceutical, biotech or food manufacturing environment (regulated by GMP standards and requirements) is preferred; with specific experience in oral solid dosage manufacturing (fluid bed, granulation, blending, compression, pan coating, or encapsulation manufacturing processes). Manipulation of drums to and from 6-inch pallets - Drum weight Utilization of scoops and other hand-held implements. Lifting boxes and/or containers up to 40 lbs. (18.2 kg) from waist to chest height. Loading product of various amounts of completion to counters and quality control devices - Overhead lift and reach (≤15 lbs.). Overhead reach, squatting, kneeling, and forward bending. Operating in various postures. Utilizing hand held brushes, wands, hoses, and other cleaning utensils. Transport of materials to and from designated lab space - Use of various job task dependent tools and work saver equipment including pallet jacks. Why You Should Join Catalent Several Employee Resource Groups focusing on D&I Tuition Reimbursement - Let us help you finish your degree or earn a new one! Generous 401K match 152 hours accrued PTO + 8 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

At **Parexel** , we don't just support drug development-we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding biopharma companies through complex regulatory landscapes to bring safer, more effective therapies to patients worldwide. You will: - Lead strategic regulatory initiatives across diverse product types and global markets - Advise clients throughout the product lifecycle, from early development to post-marketing - Share your scientific, technical, and commercial expertise to influence regulatory outcomes - Collaborate with and lead teams of respected subject matter experts - Represent Parexel as a visible thought leader in the industry - Meet new situations and learn all the time. In fact, one of the key characteristics you'll see in our Sr/VP Techs is innate curiosity along with a passion for the science, the industry, and public health. **If you're committed to public health and want to make a difference, this is the ideal role.** We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A Senior/Vice President Technical must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Senior/Vice President Technical must have a thorough understanding of the organization's consulting models and methodologies, as well as extensive knowledge of what services RS provides. A Senior/Vice President Technical provides a full range of consulting services and works within their personal area of expertise. A Senior/Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS. A Senior/Vice President Technical participates in the development of new service offerings, consulting models and methodologies. Project Execution + Works within a team environment or individually based on project needs + Works within broad project guidelines and leads issue and conflict resolution + Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives + Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action + Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met + Manages project engagements (small or large) + Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support + Provides guidance to project team members and acts as a mentor to junior staff Thought Leadership + Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field + Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums + Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met + Regularly quoted by general and industry news outlets + When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations + Contributes expertise to professional societies, academic or other similar groups influential in his/her area of expertise + Reinforces the knowledge-centered activities within RS based on their own knowledge and expertise + Facilitates improvements to Parexel business processes + Facilitates new service and consulting model development Consulting Activities and Relationship Management + Adapts the appropriate organization's consulting models and methodologies when unique situations present themselves as well as designs/improves the methodologies when needed + Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies + Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction + Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined + Acts as a loaned executive for a client when required + Facilitates resolutions to possible problems or conflicts within the project team and/or the client + Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities + Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client's business and key industry drivers + Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite + Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and build relationships which results in additional business or referrals + Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management Requirements + Education - MD required + Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and expertise in reviewing and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related medical role is required. _Depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical_ + Extensive Endocrinology, Neuroscience, Rare Disease, or Immunology experience is required. + The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance \#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.

6 AM - 6 PM 2-2-3 schedule. is 100% on-site in Winchester, Kentucky. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Production Supervisor assigns and oversees the day-to-day production tasks performed by their direct reports. the Production Supervisor collaborates with other departments including maintenance, quality, and supply chain to optimize workflow. The Role Responsible for ensuring Safety, Quality, Delivery and Costs are monitored and managed to meet site specific metrics. Supports and develops a comprehensive continuous training program for employees on the shift. Focuses on driving productivity improvements while maintaining high quality standards. Drives reductions in unplanned deviations and focuses on improving first pass quality. Ensures that labs are processing under GMP conditions and applicable SOP's are being strictly followed. Works collectively with Production Managers, Production, Materials, Planners, Technical Writers, Process Tech Leaders and other necessary areas to ensure timelines are met and results achieved. Supports customer requests and onsite observation as needed. Other duties as assigned. The Candidate Bachelor's Degree with 3+ years of manufacturing or relative experience required; OR HS Diploma/GED with 6+ years of manufacturing experience. 2+ years of Supervisory/Management experience preferred. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience. Individual may be required to stand for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor. Why You Should Join Catalent Several Employee Resource Groups focusing on D&I Tuition Reimbursement - Let us help you finish your degree or earn a new one! Generous 401K match 152 hours accrued PTO + 8 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

**Title: Principal Real World Research Delivery Lead (RWRDL)** Are you ready to take on a challenge and accelerate your career? This is an **excellent opportunity for a self-driven, autonomous leader** eager for growth and progression. Parexel is seeking a **Principal Real World Research Delivery Lead (RWRDL)** to join our team and deliver innovative Real World Research (RWR) solutions for global clients. This is a great opportunity to join our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll **lead cross-functional teams** , manage **budgets and timelines** , and serve as the **primary client contact** for innovative RWD projects. We're looking for a **strategic project leader** with strong communication skills, adaptability, and a go-getter mindset. Experience in **RWD/RWE** , **data privacy** , and **drug development** is a plus. **Career Growth:** Shape new services, mentor emerging leaders, and gain visibility in a lean PM model. As a senior leader, you will: + **Lead cross-functional teams** and act as the primary client contact for complex RWR and RWD projects. + Oversee **project proposals, budgets, timelines, and milestones** while ensuring compliance with SOPs and data privacy standards. + Collaborate with multidisciplinary teams to design and implement RWR-enabled solutions. + Mentor junior team members and help shape new services in a lean PM model. **What We're Looking For:** + Strong **project leadership experience** with proven ability to manage multiple projects and decentralized teams. + Excellent **communication skills** , adaptability, and a proactive, go-getter mindset. + Knowledge of **RWD/RWE methodologies** , data privacy, and drug development processes. + Ability to thrive in dynamic environments and lead independently. **Preferred Experience:** + RWD/RWE expertise, commercial experience, and familiarity with late-phase clinical research. + Understanding of RWD platforms, project management systems, and GCP environments. **Education:** Bachelor's degree in a science or clinical-related field; Prince II or AMPM certification preferred. **Why Join Us?** + **Career progression** and visibility in a growing RWD space. + Opportunity to **develop new services and mentor emerging leaders** . + Work on impactful projects that shape the future of clinical research. If you're ambitious, adaptable, and ready to make a difference, **apply today and lead the way in Real World Research!** \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Unlock the Power of Data in Clinical Research!** Are you passionate about transforming complex data into actionable insights? Join Parexel as an **Analytical Data Science Programmer Consultant** **/ Statistical Programmer II** and play a pivotal role in advancing drug development. In this dynamic position, you'll collaborate with industry experts to create high-quality, traceable programming deliverables-ranging from statistical outputs to interactive dashboards-while ensuring compliance with global standards. Bring your expertise in SAS, R, and CDISC standards to a team that values innovation, precision, and scientific impact. If you thrive in a fast-paced environment and want to make a difference in oncology research, this is your opportunity to shine! **Ready to elevate your career? Apply today and help shape the future of clinical data science.** The Analytical Data Science Programmer Consultants support Project Lead ADS for transforming statistical analysis plans into high-quality, traceable programming deliverables. This includes both static and dynamic outputs, such as tables, listings, figures, and interactive data visualizations or dashboards. The role involves creating and validating datasets in accordance with Study Data Tabulation Model and Analysis Data Model standards, ensuring compliance with client standards. Job Description **Responsibilities:** + Work with Project Lead ADS to develop, validate, and maintain datasets and statistical outputs for clinical trials, including Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and tables, listings, and figures (TLFs), ensuring programming accuracy, traceability, and compliance with internal processes and regulatory expectations + Develop and support programming outputs across a wide range of data types, including exploratory biomarker data and real-world data + Collaborate on Exploratory Data Analyses (EDAs), enabling insight generation to inform drug development strategies and enhance scientific communication **Qualifications:** + Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field + A minimum of 3 years of experience in statistical programming in a clinical development setting supporting Oncology trials/research, or an advanced degree with 1-3 years of equivalent work experience + Proficient in and have recent working knowledge of SAS and R + Basic understanding of statistical quality, endpoints, and QC processes + Experience with Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., SDTM and ADaM) + Demonstrated ability to deliver programming outputs independently + Fluent in English **Preferred Qualifications:** + Demonstrate critical thinking, strong organizational and problem-solving skills + Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences + Experience with drug development (early and/or late stage) + Oncology experience is highly desired + Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders \#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.

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

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.

**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.

Typical working hours are Monday-Friday 8 AM-5 PM. is 100% on-site in Winchester, Kentucky. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Project Engineer is a member of the Capital Projects Team within the Continuous Improvement, Technology, and Engineering Department. The Project Engineer drives the site and facility improvement agenda and supports the Site Capital Plan. The Role Ensures compliance to scope, cost and schedule. Drives continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety. Develops and synchronizes site functions transition through four distinct construction phases (design, build, qualify, validate). Maintains project compliance in accordance with the site quality management system. Prioritizes and guides engineering resources in the design of facility and equipment within budget. Guides the specification and selection of manufacturing / utility equipment to support site facility/process needs; Work with operations, validation, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment. Effectively manages contractors. Ensures adherence to safe work practices and guidelines. While not executing projects, supports site operations and process engineers. Other duties as assigned. The Candidate Bachelor's Degree in Engineering Field Required. Master's Degree in Engineering or Business Field would be a plus. 3+ years Engineering Project Management experience preferred. Prior experience with pharmaceutical facility construction, equipment/facility qualification & validation preferred. Prior experience managing external vendors. Prior experience project budgeting. Hands-on experience with a combination of process, controls, and equipment engineering is required; Change control and validation experience is critical. Six Sigma / Lean Manufacturing / Professional Project Management skills preferred. Individual may be required sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen. Why You Should Join Catalent Several Employee Resource Groups focusing on D&I Tuition Reimbursement - Let us help you finish your degree or earn a new one! Generous 401K match 152 hours accrued PTO + 8 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities. This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence cross‑functional teams in a fast‑changing environment. Key Responsibilities: Documentation & Compliance - Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements. - Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). - Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals. Regulatory Submissions - Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. - Provide local input for change control and post-approval requirements. - Collaborate with global functions to obtain documentation aligned with local requirements. Audit & Inspection Support - Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure. - Provide local expertise and responses to inspection queries. Cross-Functional Collaboration - Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes. - Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies. Strategic Leadership - Lead regulatory strategies for product launches and integrations at the affiliate level. - Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships. - Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation. Education - Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent. - Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences. - Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus. Experience - 3-5+ years of local regulatory knowledge and experience in a health authority-facing role. - Demonstrated previous life cycle management experience is required. - Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. - Proven expertise in managing regulatory submissions, timelines, and cross-functional teams. - Strong project management and leadership skills. - Experience influencing Commercial Operations stakeholders and driving business-critical decisions. - Demonstrated ability to adapt and succeed in rapidly changing environments. \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**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.

We are looking to fill a **Scientist II or III - Metrology Specialist** position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer sponsorship.** **Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment** . This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement **Qualifications -** B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline + **Scientist II** - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience + **Scientist III** - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience **Responsibilities** + Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation + Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships + Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded equipment or software packages + Support the purchase, installation, and equipment qualification of new laboratory equipment + Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support + Originate and progress Notice of Event (NOE) and Change Management (CM) records + Perform and document investigations and assist in developing/implementing CAPA plans + Represent the laboratory on all aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and Experience** + Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks + Capable of working independently under moderate supervision + Strong verbal and written communication skills + Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators **Desired Skills and Experience** + Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. + Experience with computerized standalone systems GMP validation requirements + Familiarity with authoring relevant instrument standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Typical working hours are Monday-Friday 8 AM-5 PM. is 100% on-site in Winchester, Kentucky. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Analytical R&D Lab technician is an entry level position and is responsible for housekeeping and assisting the analytical scientists to perform and complete their daily activities as needed to meet the business needs. In this role, the lab technician should be able to work safely around lab chemicals and follow GMP guidelines to safely perform duties that maintain the overall cleanliness and organization of the lab space. The Role Proper disposal of chemical waste and broken glass drums. Trash removal. Daily sweeping and weekly mopping of lab floors Hand washing and proper use of industrial dishwasher to maintain supply of clean lab glassware. Dusting and clutter removal. After completing training/qualification and demonstrating proficiency perform daily balance weigh checks and ensure balance work areas are neat, clean, and clear. Responsible for daily standardization of lab pH meters, or when needed. Ensures regents and supplies are available for Analysts and ensures that reagents and chemicals are properly labeled and not expired. Ensure designated work areas for pH meters are neat, clean, and clear. Supports AR&D in lab operation tasks such as chemical inventory management, standards inventory, consumable supplies area, waste disposal, safety initiatives and other services as necessary. Under the direction of supervisor, prepares lab reagents, test solutions, buffers, mobile phase, and other solutions necessary for evaluation and testing of samples. Under direction of supervisor, after completing training on lab equipment and instruments and demonstrating proficiency in various test procedures, perform testing of samples and products, complete documentation and report results in a timely fashion as per cGLP and cGMP. Maintains a safe work environment. Build and maintain communication and collaboration with other departments such as product development, quality control, quality assurance and others as necessary. Comply with Catalent, FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies. Other duties as required in support of Catalent Pharma Solutions high performance The Candidate HS Diploma or GED required. Associate's Degree in Science or Technology preferred. Previous experience in chemical, medical or pharmaceutical setting, preferred. Previous exposure to cGMPs or cGLPs is preferred. Working knowledge of policies and procedures necessary in operating/handling equipment and materials used in an analytical lab setting preferred. Should possess computer skills in Microsoft Office (Word and Excel) and other applicable software. Individual may be required to sit and stand for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor. Why You Should Join Catalent Several Employee Resource Groups focusing on D&I Tuition Reimbursement - Let us help you finish your degree or earn a new one! Generous 401K match 152 hours accrued PTO + 8 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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** : Investigator Financial Analyst II **Job Introduction** : At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an **Investigator Financial Analyst** **II** to join our team. As an Investigator Financial Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences to patients by steering the investigator budget management for crucial projects. Through the collaboration and diversity of the Investigator Payment Division the Investigator Financial Analyst is provided with opportunities to excel and discover where your skills can take you. **Who we are looking for** : Curious individuals interested in understanding investigator budget economic drivers. Who are detailed-oriented while assisting in translating the clinical conduct into a financial impact and proactively advising the project leader and the project financial analyst on how to influence critical budget and cash flow levers to prevent negative impact project financials. **What you'll do** : + Lead the monthly investigator payment forecast cycle and support project analysis requirements, including a review of accruals, costs incurred, contracts signed, and patients enrolled. + Collaborate with clients, clinical team members, and other members of the organization to gather information and/or explain the financial impact of the observed clinical conduct. + Manage all required variance analyses for the set of projects, with insight and identify risks in the project forecast and to the budget. + Present updates on financial status of investigator payments for assigned projects and create information in response to client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio. **Why join us:** Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Enjoy work life balance and flexible working hours. **Parexel US Benefits** : + Health, Vision & Dental Insurance + Tuition Reimbursement + Vacation/Holiday/Sick Time + Flexible Spending & Health Savings Accounts + Work/Life Balance + 401(k) with Company match + Pet Insurance Full list of benefits available here: *********************************** **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, and you're exposed to a world of experiences and open doors. 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, send them the link to apply! \#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.

Typical working hours will be Monday-Friday 8 AM-5 PM is 100% on-site in Winchester, Kentucky. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Facilities Engineer supports the efficient operation, maintenance, and improvement of building systems and infrastructure. The Facilities Engineer is responsible for planning, implementing, and overseeing projects related to mechanical, electrical, and structural systems to support a safe, reliable, and sustainable facility environment. The Role Function as the subject matter expert to ensure proper operation and maintenance of building systems and utilities in a manufacturing environment. Ensure compliance with safety, regulatory, and building codes (OSHA, EPA, NFPA, etc.). Coordinate routine inspections, preventive maintenance, and repairs to ensure safe and efficient operations. Support onsite personnel and contractors for facility system upgrades, maintenance and emergency response. Maintain documentation and records of maintenance activities, work orders and safety checks. Perform root cause analysis, process improvements, and lead troubleshooting. Ability to discern and recommend best solution among multiple alternatives using information at hand and engineering judgment. Execute projects (capital or expense) with no previously defined scope. Perform projects of short- and long-term focus. Ability to lead cross functional process teams in projects focusing on primary functional area. Contributes to cross functional teams in projects focusing on other functional areas. Effectively communicates potential projects, project outcomes, and results through visual, oral, and written forms. Responsible for contributing to investigations into production related deviations of batches, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met. Responsible for aiding in the development and execution of CAPAs. Other duties as assigned. The Candidate Bachelor's Degree in Engineering or related field required. 2+ years of relevant engineering experience in facilities or building systems required. Prior experience in a pharmaceutical manufacturing setting (desired but not necessary) Individual may be required to stand and walk for an extended period of time. Specific vision requirements include reading of written documents Why You Should Join Catalent Several Employee Resource Groups focusing on D&I Tuition Reimbursement - Let us help you finish your degree or earn a new one! Generous 401K match 152 hours accrued PTO + 8 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

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.

Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for complex global labeling initiatives. This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products across international markets. You will define labeling strategy, lead governance committees, and collaborate cross-functionally to deliver compliant, high-quality documentation throughout the product lifecycle. **Key Responsibilities** **Strategic Labeling Leadership** + Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE). + Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile. + Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership. + Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities. + Remain current with global labeling regulations and provide training to internal stakeholders. **Governance & Committee Leadership** + Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team-set agendas, drive decisions, and ensure timely implementation. + Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets. + Influence external labeling landscape through policy intelligence and strategic engagement. **Operational Oversight & Compliance** + Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. + Maintain labeling documentation within eDMS and regulatory tracking platforms; ensure robust version control and SOP adherence for audit readiness. + Manage change control documentation, specimen requests, and verify part numbers for correct submissions. + Ensure FDA Section 508 accessibility compliance on U.S. labels. **Global Implementation & Health Authority Engagement** + Support regional implementation of CDS updates and monitor compliance across markets. + Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations. + Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities. **Advertising, Promotion & Artwork** + Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance. + Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs; oversee mock-ups and production for combination products/devices. **Special Projects** + Lead annual strain updates for Northern/Southern Hemisphere flu campaigns. + Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting. **Qualifications** **Education:** + Bachelor's degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred. **Experience:** + 5-7 years in biotech/pharmaceutical industry; 2+ years in global labeling/regulatory with global strategic leadership responsibilities. + Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings. + Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. + Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations. **Technical Expertise:** + Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise). + Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS. **Core Competencies:** + Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred). + Demonstrated problem-solving ability with risk analysis and sound decision-making. + Strong collaboration skills, with experience working in global, cross-cultural, matrix environments. + Organizational skills to interact seamlessly both internally and externally on compliance matters. + Proficient regulatory knowledge, including scientific concepts within labeling and their global implications. + Effective communication skills for explaining concepts, options, and impacts. + Attention to detail with the ability to think strategically. + Fluency in English (verbal and written); additional languages would be an asset. While candidates located in the EST time zone are preferred, candidates in other U.S. or Canadian time zones who have the flexibility to provide coverage during EST hours will also be considered. **Why Join Us** This is an opportunity to shape global labeling strategy, lead governance processes, and ensure patients worldwide receive accurate and compliant product information. You will work across diverse markets, influence external landscapes, and contribute to innovative campaigns in a dynamic, collaborative environment. \#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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Pharmaceutical Technician is primarily responsible for the manufacturing of pharmaceutical product per established specifications. They will perform all the basic tasks relating to weighing, transferring, mixing, and processing of raw material to create a finished good. The Pharmaceutical Technician is also responsible for a variety of support activities, such as cleaning of production rooms, corridors, and equipment. All responsibilities are dictated by strict regulations (e.g., cGMP, SOP, batch records). Shift: B/D Shift (6 PM-6 AM 2-2-3 schedule). This role is 100% on-site in Winchester, Kentucky. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. **The Role** + Understand and follow all environment, health, and safety requirements; in particular, personal protective equipment (PPE) requirements and understand and follow all current Good Manufacturing Practices regulations (cGMP), applicable standard operating procedures (SOP), and executed batch records. + Complete all required training and qualifications regarding the role in a timely manner; in particular, ComplianceWire assignments. + Weigh and transfer materials using calibrated scales and balances, utilize hand tools to assemble and disassemble various types of machinery and perform basic calculations with aid of a calculator. + Accurately complete all applicable documentation pertaining to completed tasks; in particular, batch records, forms, and cleaning records. + Perform detailed cleaning of manufacturing suites and equipment using various cleaning solutions and in accordance with cleaning records and maintain a work environment that is clean, organized, and audit-ready. + Cooperate seamlessly with coworkers, Room Leader, Functional Leader, and Production Supervisor and perform all tasks within a team as assigned by Room Leader, Functional Leader, and Supervisor. + Interact with customers and visitors in a highly professional manner at all times. + Other duties as assigned. **The Candidate** + High School Diploma or Equivalent Required. + Prior experience working in a pharmaceutical, biotech or food manufacturing environment (regulated by GMP standards and requirements) is preferred; with specific experience in oral solid dosage manufacturing (fluid bed, granulation, blending, compression, pan coating, or encapsulation manufacturing processes). + Manipulation of drums to and from 6-inch pallets - Drum weight + Utilization of scoops and other hand-held implements. Lifting boxes and/or containers up to 40 lbs. (18.2 kg) from waist to chest height. Loading product of various amounts of completion to counters and quality control devices - Overhead lift and reach (≤15 lbs.). + Overhead reach, squatting, kneeling, and forward bending. Operating in various postures. Utilizing hand held brushes, wands, hoses, and other cleaning utensils. Transport of materials to and from designated lab space - Use of various job task dependent tools and work saver equipment including pallet jacks. **Why You Should Join Catalent** + Several Employee Resource Groups focusing on D&I + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + Generous 401K match + 152 hours accrued PTO + 8 paid holidays **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .