PDA jobs in Phoenix, AZ

Responsible for assuring the highest quality level of the company processes and products maintaining monitoring of qualifications and validation of facilities, instruments, and equipment, performing, and supporting cleaning and process validation, ensuring proper performance as per company procedures, and providing excellent service to guarantee customer satisfaction. Support validation activities for aseptic and non-aseptic production environment. Focus of position : Calibration/Metrology/Equipment Qualification Manages, coordinates, performs, and reports all activities related to the calibration of equipment used at Pharmaceutics International Incorporated. Support other validation activities such as equipment commissioning, qualifications, and process validations. Responsibilities: The essential functions of the position include, but are not limited to: Performs calibrations for all equipment and instrumentation involved in, but not limited to, manufacturing processes at Pharmaceutics International Incorporated. Understands equipment/instrument specifications, calibrations, out of specifications, tolerance limits for different instruments Creates documentation that accurately describes the procedures required to effectively calibrate equipment. Provides initial Standard Operating Procedure (SOP) training to all responsible personnel. Assists in the troubleshooting of equipment and contacts maintenance for all repairs when necessary. Review equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations prepared by other team members. Assures that assigned obligations are conducted in accordance with cGMPs, or any other company approved documentation. Interacts with peers and vendors to ensure project timelines are achieved and offering satisfactory alternatives when necessary. Execute protocols and related activities associated with cleaning and process validation, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring. Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA. Initiate, follow-up, close out and implementation of corrective and preventive actions. Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to products and processes. Coordinate with cross functional teams for internal and external audits. Provide all required documentation. Interacts with other departments to ensure project activities are performed in a timely manner. Scans, archives, and organizes all validation documentation. Continues to increase knowledge of latest process technologies within the pharmaceutical industry. Additional functions and responsibilities as needed or assigned. Essential Specialized Knowledge and/or Skills to Perform Job: Ability to read, write and speak English fluently. Ability to communicate effectively to team members on a routine basis Knowledge of cGMPs, manufacturing procedures of Pii's product line and company policies/regulations; knowledge of manufacturing operations and validation guidelines - SOPs, FDA, OSHA, DEA and MSDS requirements. Qualifications: Education/Experience: Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Associate with a minimum of 2 years experience within the pharmaceutical, cosmetic, or food industry, specifically with Metrology/Calibrations. Competency: To perform the job successfully, an individual should demonstrate the following competencies: Analytical - Working knowledge of cGMPs and internal SOPs; identifies, collects and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner. Customer Service - Responds to requests for service and assistance with professionalism, courtesy and confidence. Technical Skills - Ability to make timely decisions, root cause analysis and ability to define effective corrective and preventative action. Interpersonal Skills - Interacts with management and non-management employees across all department within Pii and outside clients. Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarifications. Team Work - Balances team and individual responsibilities; able to build morale and group commitments to goals and objectives; focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; remains open to others ideas and not afraid to try new ideas. Diversity - Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect behavior and feelings. Ethics - Works with integrity and ethically; maintains confidentiality Professionalism - Treats others with respect and consideration. Attendance/Punctuality - Is consistently at work and on time. Dependability - Follows instructions, responds to management direction; takes responsibility for own actions. Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality. Safety and Security - Observes safety and security procedures; responsible for meeting department safety objectives and to develop on-going safe operating procedures consistent with the job requirements. Language Ability - Ability to read, write and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Math Ability - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and percents. Reasoning Ability - Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Computer Skills - Basic computer skills, i.e., Outlook, Microsoft Word, Excel and PowerPoint Physical Demands Specific vision abilities required include peripheral vision, depth perception, and ability to adjust focus. Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). Work Environment and Physical Demands: The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employees are supplied personal protection equipment (PPE), safety shoes, glasses and hearing protection whenever necessary for critical processes within manufacturing. While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger; handle; or feel; reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required include peripheral vision, depth perception, color vision and ability to adjust focus.

As a Pharmaceutical Packaging Technician, you will be responsible for packaging a range of pharmaceutical products for clinical and commercial use. You will operate, set up, maintain, and clean equipment while following established standardized procedures. Additionally, you will thoroughly document production efforts to ensure compliance with regulatory guidelines. Responsibilities: Performs assigned duties as outlined in the SOPs for packaging of pharmaceutical products according to written instructions from Packaging Labeling records with assistance from a trained packaging technician. Under the guidance of a junior or senior packaging technician, assists in the setup, operation, disassembly, and monitoring of packaging equipment per specifications or packaging instructions for solid, semi-solid, and liquid dosage forms. Assists in performing cleaning procedures on packaging equipment and areas using written procedures, cleaning solutions, and materials under the guidance of a trained packaging technician. Notifies Management of any observed cGMP violations encountered during the performance of job duties and responsibilities. Follows all safety procedures within the cGMP packaging areas and reports all discrepancies to management immediately. Ensures the work area is neat, clean, and orderly by end of the shift. Enhance organizational reputation by striving to meet and exceed performance expectations. Work cooperatively with Quality Assurance and other internal departments to ensure appropriate coordination of manufacturing activities. Maintain job knowledge and training current to ensure compliance in all activities. To identify, investigate, participate in, and take ownership of compliance issues and deviations when discovered. Support the identification and implementation of corrective and preventive actions (CAPAs). Perform other duties as assigned. Qualifications: HS/ GED required with a minimum of 18 months experience as a Junior Packaging Technician within Pii or a minimum of 3 years in the pharmaceutical, cosmetic, or food industry, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Ability to add, subtract, multiply and divide all in units of measure, using whole numbers, common fractions and decimals, and percentages. Must have the ability to learn the metric system, weight, and volume measurements. Mechanically inclined; reads and interprets equipment and process documents; follows operating instructions. Exhibits objectivity and openness to others' views. Takes personal accountability for contributions to the team and organizational results. Demonstrated accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality. Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise. Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

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

About 3E:We are a mission-driven company dedicated to creating a safer and more sustainable world!3E provides award-winning regulatory expertise and cutting-edge technology that seamlessly integrates data and intelligence regarding chemicals, regulations, products, and supply chains for over 5,000 customers globally.With more than 35 years of experience and 15 locations across North America, Europe, and Asia, we are connecting our customers to a new class of expert-led AI solutions, specifically designed to accelerate future product compliance with trust, speed, and domain authority. Are you ready to help shape the future? Come join us! About the Role:At 3E, we're not just passionate about data and compliance-we're passionate about the people who rely on them. As a Regulatory Solution Advisor, you'll be at the heart of enabling our customers to navigate complex global environmental, health, and safety (EH&S) regulations with clarity and confidence. You'll partner with our Sales team to showcase impactful, scalable solutions that support clients in achieving their business goals, all while advancing 3E's mission to make the world safer, more sustainable, and more compliant. This role is a great fit for someone who is customer-focused, thinks strategically, and thrives in cross-functional environments. You're naturally curious and consultative-asking the right questions to uncover the “why” behind a client's challenges. You're energized by change, resilient and adaptable, and enjoy working hands-on with teams across sales, product, and delivery. Most importantly, you're proactive and accountable, driven by the opportunity to make a meaningful impact. This position offers hybrid flexibility and should be based near one of our U.S. office locations: Carlsbad, CA; Bethesda, MD; or Canton, OH.What You'll Do Be a Trusted Partner in the Sales Journey Collaborate with Business Development to shape new and cross-sell opportunities by aligning 3E's compliance solutions with customer priorities. Guide solution design by uncovering client needs through discovery conversations and business process reviews. Deliver compelling demos and presentations that connect regulatory requirements with business value. Support proposal development, including detailed Scope of Work (SOW) documents and RFI/RFP responses. Deliver Value That Lasts Leverage a “value connection mindset” to help clients understand the broader impact of their compliance challenges. Provide insight into implementation complexities and offer scalable, customer-centric recommendations. Drive commercial impact by helping teams meet and exceed sales goals through strategic consultation. Act as an Industry Advocate Stay ahead of regulatory changes and emerging trends in EH&S, supply chain, and product stewardship. Share insights and customer feedback with Product and Leadership teams to influence our roadmap. Represent 3E at industry events and tradeshows-sharing your expertise and elevating our brand presence. What Makes You a Great Fit Bachelor's degree in a relevant field; advanced degree a plus. 5+ years of experience in regulatory environments such as EH&S, product compliance, or chemical regulations (e.g., REACH, GHS, TSCA, WHMIS, HazCom). 3+ years in client-facing roles, ideally involving solution design or pre-sales. Strong presentation, collaboration, and consultative communication skills. Proficiency in Salesforce.com. Travel Expectations: This role requires occasional travel-up to 10 days per month-primarily within the United States. Travel is typically short (1-2 day trips) and often grouped to accommodate meetings with multiple customers. Most travel will be in support of presales efforts and customer engagement. Preferred: Experience with 3E's products is a bonus. Familiarity with regulatory platforms or tools. Background in solution selling or technical sales in a high-growth environment. What is in it for you? Impactful Work: Every day, you'll contribute to initiatives that protect people, safeguard products, and help businesses thrive for an industry-leading organization. Collaborative Culture: Work alongside a team of dedicated professionals passionate about delivering excellence and innovation. Career Growth: We will set you up for success with a hands-on training program to equip you with the skills you'll need to accomplish results. Enjoy opportunities for professional development in an environment that celebrates creativity, flexibility, and results. Unlimited Earning Potential: We offer a market-leading competitive incentive plan with an uncapped commission structure rewarding outperformance. Pay Transparency:The anticipated salary range for this position is $90,000-$125,000 per year. The final offer will depend on several factors, including the successful candidate's skills, depth of work experience, location, and relevant licenses/ qualifications. Each offer is determined based on individual strengths and relevant business considerations. In addition to the base salary, certain roles may qualify for a performance-based incentive and/or equity, with eligibility depending on the position. These rewards are based on a combination of company performance and individual achievements. Our US Benefits Include:Health, dental, and vision insurance Life insurance and disability coverage Generous PTO accrual and paid parental leave 401(k) plan with company matching Employee assistance program Voluntary supplemental benefits (Accident, Hospital Indemnity, Critical Illness) 3E is currently authorized to hire in the following U.S. states:Alabama, Arizona, California, Colorado (excluding Denver), Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois (excluding Chicago), Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New York (excluding New York City), North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. Disclosures:3E is committed to a diverse and inclusive work environment. 3E is an equal opportunity employer and does not discriminate based on race, nationality, gender, gender identity, sexual orientation, protected veteran status, age, disability, or any other legally protected status. For applicants who would like to request accommodation please send an email to ********************** Visit us at ********************* Follow us at ******************************************************* Policy and Candidate Privacy Notice Agencies: 3E is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at 3E via email, the Internet, or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of 3E. No fee will be paid in the event the candidate is hired by 3E because of the referral or through other means.

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics. **** + Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development + As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR + Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses + Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and publications. + Core team of developing final study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline. + Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks. + Takes full responsibility in managing biostatistical tasks (as listed above) for one therapeutic area and provides strategic technical support to other clinical projects. + Provides technical direction to supporting statisticians working on projects on a day-to-day basis. **Qualifications/ Required** **Knowledge/ Experience and Skills:** + Understands the company's products, the competition, and the pharmaceutical industry in general. + Demonstrates a competent knowledge of the company's work tools, processes, and policies. + Maintains a current awareness of new drug developments and statistical methodologies in the business. + Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions. + Effective communications within biostatistics function and with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation. + Familiar with regulatory submission process in US and EU. **Skills** + In-depth knowledge of statistical principles, applications, and SAS/R programming software. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. **Educational Qualifications** + PhD or Master's degree in Statistics or Biostatistics. + Minimum 7 years (PhD) or 9 years (master degree) of experience in the pharmaceutical industry Experience in CNS area is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job DescriptionDescription(Greenbelt, MD or Austin, TX) In this role, you will join the Regulatory Affairs Department, which provides regulatory, legislative, policy, and compliance counsel to JSI departments and JSI clients. Our department has nearly doubled this past year, adding more diverse expertise in federal and state communications policy and compliance - as our clients deploy more next-generation networks and connect more customers. We are looking for leaders to drive us into the future and individuals who are prepared to do whatever it takes to create a truly exceptional client experience every day. Key ResponsibilitiesThis role supports several different functions: Regulatory Reporting Perform daily management of JSI's web-based regulatory tracking tool to help clients mitigate risk and stay on top of their regulatory compliance requirements. This includes managing the internal tracking team and training new team members, interfacing with any third-party vendors, and ensuring client satisfaction. Ensure all projects are delivered on time within the stipulated scope and budget. Ensure resource availability and allocation. Coordinate and manage relationships with internal staff and clients. Perform product demos to potential clients and train staff on providing demos. Send proposals to potential clients and onboard new clients. Measure project performance using appropriate project management tools. Perform risk management analysis to reduce project risks. Report and escalate to upper management as appropriate. Create and maintain comprehensive project documentation. Perform policy and compliance research using internal tools and publicly available data, especially on state telecommunications regulatory matters. Other duties as assigned. Client and Business Development / Operational Excellence Prepare client communications, interest forms, templates, and tracking sheets. Manage proposal tracking system. Proofread and format documents and presentations for quality control. Monitor the Regulatory Support email account. Develop and maintain visual dashboards, Regulatory trackers, templates, and client pipelines. Update SharePoint Regulatory site Partner with the Vice President, Strategy & Operations Lead, Product Manager, and other leadership to drive operational excellence for the department and the company. Qualifications A bachelor's degree in communications or a related field. Any relevant project management-related experience Self-starter with a great attitude. Strong attention to detail and analytical skills Enjoys interacting with internal and external clients. Proficiency in software programs such as Microsoft Office (Outlook, Teams, Excel, Word, and PowerPoint), SmartSheets, and Adobe Acrobat Strong research skills Excellent organizational skills and the ability to manage and prioritize assignments in a fast-paced environment. Excellent written and oral communications skills. Ability to work well with individuals across diverse teams and cultures. BenefitsAt JSI, you will have a career that is rewarding and challenging on every level of the organization. JSI is committed to providing our employees with: Professional growth and development opportunities A diverse, dynamic, and stimulating work environment Educational opportunities A competitive salary and benefits package

About the Role Superior Skilled Trades is seeking an experienced and highly motivated Fire Sprinkler Foreman for a direct hire opportunity with a leading fire protection contractor in the Odenton, MD / Baltimore, MD area. This is an excellent role for a proven foreman who takes pride in quality work and is passionate about team leadership and safety. You'll lead field installation crews on fire sprinkler projects ranging from new construction to retrofits and tenant improvements. Responsibilities Installation & Leadership Lead and supervise the installation of fire sprinkler systems per design plans and applicable codes Oversee pipe fittings, hangers, couplings, and sprinkler placement Ensure crew productivity and safety - manage multiple crews as needed on larger projects Project Oversight Maintain assigned tools, equipment, truck, and electronics in proper working condition Communicate with project designers regarding material needs or changes Receive and verify materials - report any shortages Produce and submit accurate red-line drawings Provide project and schedule updates to Field Superintendent and Project Manager Attend project meetings and coordination sessions as required Submit daily progress reports and required documentation Safety & Compliance Maintain a safe job site and enforce all project-specific rules and policies Immediately report any injuries, property damage, or incidents Ensure full compliance with local codes, project specifications, and company standards Training & Development Mentor and train fitters/helpers on proper installation techniques and job-site safety Foster a positive and productive work environment Administrative Tasks Submit accurate timecards and receipts weekly Complete required paperwork for both Superior Skilled Trades and client as needed Qualifications Education & Experience High school diploma or GED required 3-5 years of fire sprinkler installation experience Previous leadership/foreman experience strongly preferred Requirements Clean driving record Pass pre-employment drug screen Ability to lift up to 75 lbs without assistance Strong working knowledge of fire sprinkler systems, fire codes, and installation standards Experience reading and interpreting construction drawings and plans What's In It For You This Direct Hire position offers competitive pay and a comprehensive benefits package: Competitive Pay Medical, Dental, Vision Insurance Voluntary Life Insurance Short-term & Long-term Disability Flexible Spending Account Paid Time Off & 6 Paid Holidays 401(k) with Company Match Company-Issued Tablet Paid Training & Certifications If you're an experienced Fire Sprinkler Foreman looking for a direct hire opportunity with a company that values craftsmanship, safety, and leadership, we encourage you to apply today! Superior Skilled Trades is hiring now - don't miss this opportunity.

Job Summary and Purpose The Executive Director of Infrastructure & IT Operations is the executive leader responsible for defining and executing a secure, scalable, and modern hybrid infrastructure strategy across global data centers, cloud platforms, corporate networks, and end-user services. This role ensures operational excellence, cost optimization, reliability, and alignment with organizational priorities. The Executive Director partners closely with Security, BRM, PMO, Application Engineering, Data, Compliance, and Corporate IT to drive unified execution across all technology towers. This role also serves as the primary liaison to senior business leadership, ensuring clear communication, alignment, and accountability for all infrastructure-related projects, service levels, operational issues, and strategic initiatives impacting their business units. Main Duties & Responsibilities Collaborate extensively with Security, BRM, PMO, and Application Engineering to ensure unified governance, operational smoothness, and project delivery across the enterprise. Act as the executive point of contact for BU senior leadership, ensuring transparent communication, expectation alignment, issue escalation, and partnership for all infrastructure-related initiatives, outages, and service improvements. Lead global cloud, data center, network, and endpoint operations. Own modernization across AWS, Azure, and on-prem infrastructure. Oversee colocation data centers, server rooms, and lab compute. Direct corporate network engineering (LAN/WAN/SD-WAN/Wi-Fi). Lead end-user computing services (M365, Intune, Entra ID). Establish infrastructure governance and security controls. Partner with Cybersecurity on zero-trust and identity frameworks. Oversee OPEX/CAPEX planning and vendor management. Develop directors, managers, and global engineering teams. Communicate strategy and risks to executive leadership. And other job duties as assigned by the line manager. Education and Experience Minimum Education & Experience: Bachelors in computer science, Information Systems, or related field. 12+ years of infrastructure/cloud leadership experience in a Director or above level. 15+ years overseeing hybrid cloud and Datacenter and Engineering functions. Preferred Education & Experience (optional): • Master's degree preferred. • Experience in regulated industries. • Certifications such as AWS/Azure Architect, ITIL, or TOGAF. • Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job. Knowledge, Skills, and Competencies Hybrid cloud (AWS/Azure) architecture expertise Data center, compute, storage, and network engineering End-user computing (M365, Intune, Entra ID, identity & access) Disaster recovery, high availability, and resiliency design Financial and vendor management Executive communication and stakeholder alignment Leadership of global engineering teams Understanding of SOC2, ISO27001, HIPAA, NIST Ability to perform in high-growth, matrixed environments #linkedin-remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $227,600 - $284,500 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Job DescriptionDescription: With the support of the Practice Manager and Clinic Coordinator, assist to ensure the smooth and successful running of the clinic. To be responsible in assisting to produce performance and quality standards within the Orthodontic Clinic, delivered through customer service skills, attention to detail and common sense. To be responsible for the maintenance of the practice's equipment located within the clinic, reporting any issues to the Practice Manager. Duties include: Help to maintain patient flow pattern by seating patients promptly and begin procedures Place separators, elastic chains, and wires. Prepare teeth for bonding of braces and Invisalign attachments Scales cement and checks patient for loose brackets or bonds Monitor oral hygiene of patients, instructs on correct brushing Deliver all instruments to sterilization to be sterilized Keeps drawers stocked, clean, and replenished Debriefs patient and parents after appointments Take X-rays, CBCT, iTero scans, and impressions. Charts notes for patients seen, Chart scheduling of next appointment type needed and the weeks out Answers any questions for parents regarding treatment Assists Orthodontist in any given procedure Anticipates what doctor may need during appointment and takes action Cleans chair and moves around clinic with sense of urgency Back up Sterilization Preforms side tasks daily and/or monthly as assigned by Clinic Coordinator Attends all other staff meetings and Daily Huddles. Abide by established office policies and procedures Representing the practice in a positive way inside and outside of the office. Requirements: At least 1 year of dental assisting experience is required (orthodontics preferred) be self-motivated, organized, and have a positive attitude possess great understanding of dental terminology have excellent communication and written skills have excellent public relations skills work well with patients and team be experienced in delivering high-level customer service Committed to the position arriving on time daily and staying late as needed.

THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.

At PriorityPet, our goal is to make an impact on the health and wellness of pets in the community. In fact, our Core Values are (quite literally) written with PETS in mind: Passion, Engagement, Trust and Service. We pride ourselves on maintaining a culture of open communication and collaboration to deliver innovative solutions in today's ever-changing veterinary environment. Together, we want to partner with veterinarians to help build a network of Urgent Care practices across the country - tell us where you want to build your practice, and we will provide you with the full support to make it happen for $0 out-of-pocket. This is your chance to become a practice owner without any of the headache! Job Description We are seeking talented and entrepreneurial Veterinarians to partner with us and become Medical Directors in a practice that we will build together. We're offering immediate ownership/equity opportunities with no out-of-pocket cost! We will provide you with a brand-new building and the state-of-the-art equipment needed to allow you to deliver world-class medicine. Location is completely flexible - let us know where you want to build! This is a prime opportunity to take the next step in your career; become a practice owner and as leader in your hospital, build the culture that you have always envisioned. Most importantly, we emphasize and provide medical autonomy to all our practices since you are the experts in medicine. Our role is to provide the business support and solutions to help you, and your practice, succeed. To learn more about us, please visit our website at ********************************* We offer our Veterinarians: * Competitive compensation with generous performance bonuses * Ownership/Equity opportunities with no out-of-pocket cost * Comprehensive Benefits (100% employer paid medical premiums, liability coverage, paid licensing/fees including DEA, CE allowance, employee assistance program & VIN membership. Optional enrollment in Dental, Vision, Life, 401K w/ company match, pet care discounts and more!) * Student Loan and Relocation Assistance * PTO, parental leave, and company holiday package * Work-life balance, Flexible Scheduling and no overnights: We are family friendly, and your mental health is important to us. We appreciate the importance of maintaining a healthy life outside of our work family * DVM Mentor Network Qualifications * Doctorate in Veterinary Medicine (or equivalent) from an accredited university, and an active veterinary state license * 3+ Years of Veterinarian Experience * Current DEA License/USDA Accreditation or obtained upon hire * Compassionate leader with the experience and willingness to manage a team and promote a positive clinic culture as it aligns with Alliance Animal Health's core values * Effective communicator with a drive to provide the highest quality medicine and mentor other veterinarians to do so as well Additional Information WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin

Under minimal supervision of QC management, the QC Chemist performs physical and chemical testing on raw materials, in-process and finished products, as well as stability samples. Utilizes established methods and standard operating procedures and laboratory equipment to perform testing of materials. Prepares high quality written documentation, such as notebooks, logbooks, standard operating procedures (SOPs) and LIMS reports. Trouble shoots analytical equipment. Provides training on analytical methods and new technologies. Responsibilities: Performs analytical testing of raw materials, in-process materials, finished products and stability samples. Operates laboratory equipment such as balances, pH meters, hardness testers, particle size analysis, LOD, Karl Fischer, Melting Point, etc. in accordance with laboratory SOPs and test methods. Effectively performs routine testing using HPLCs, GCs, UV-VIS, FT-IR and ICP-MS equipment in accordance with SOPs and test methods. Performs data analysis and evaluation of test results. Prepares reports and reviews data. Maintains accurate records of test data, maintains laboratory notebooks and logbooks in accordance with company guidelines and GDPs. Assists in writing and revising SOPs and tests methods as needed. Follows documented procedures: SOPs, test methods, and transfer protocols. Performs routine maintenance, calibration, and performance verification on applicable instruments. Performs investigation activities and writes deviation and investigation reports. Suggests and writes CAPAs. Follows lab safety procedures. Perform other duties as assigned. Qualifications: Bachelors in chemistry or related physical/biological science, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Minimum of 3 years' experience in Pharmaceutical Analysis Must understand analytical chemistry. Demonstrated knowledge of cGMP regulations and ICH guidelines Computer literacy and ability to use data acquisition and processing software, such as EMPOWER 3 Demonstrate the ability to read, analyze, and interpret USP/NF methods, SOPs and technical procedures manuals, and batch records. Demonstrate the ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instruction in mathematical or diagram form. Knowledge of basic laboratory practices, methods, and techniques Demonstrate the ability to carry out work assignments communicated orally or in writing. Demonstrate familiarity with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities. Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate ability to acquire the appropriate knowledge from resources on with electronic Quality Management Systems such as MasterControl and Trackwise. Demonstrate understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. **Job Summary** We are seeking a Research Support Specialist I for our Insourcing Solutions site located in Poolesville, MD. + Prepare and administer research treatments; collect and record physiological data (weight, temperature, pulse, respiration) + Perform technical procedures as needed associated with the Animal Study Proposals in relation to NHP retroviral, human respiratory and flavivirus studies to include but not limited to blood collection, IV catheterization, intubation, broncho-alveolar lavage, tracheal and nasal lavages, documented research observations, and administration of research treatments + Must have a basic understanding of aseptic technique, anesthesia induction, monitoring, and recovery as well as drug dosage calculations and administration + Assist Veterinarian & Sr. RSS staff with surgeries and specialized procedures + Perform daily animal health observations and report any abnormal findings to veterinarian + Maintain electronic medical records, send daily emails regarding animal health information to vet staff + Collect, preserve, and prepare blood, urine, stool, and tissue samples + Participate in study related necropsies/tissue harvest + Set-up for procedures and prepare supplies and equipment + Ability to maintain freezer organization and sample inventory + Practice universal precautions appropriate to different levels of ABSL. Work safely with animal / human pathogen biohazards and help to maintain the research animal facility as a safe work environment / operation + Report any animal health, care, and / or wellbeing concerns to the appropriate facility management staff + Report any facility infrastructure issues, relative to the animal care and support areas to the appropriate facility management **Job Qualifications** The following are the minimum requirements related to Research Support Specialist I: - High school diploma or general education degree (GED) required. BS degree in Animal Science, Biology, or similar discipline, or A.A. in Veterinary Technology is preferred. - 2-3 years' experience working with non-human primates in biomedical research or 2-3 years Veterinary Hospital technical experience preferred. - Must have computer program proficiency such as MS Word / Access / Excel. Must have a proficient technical vocabulary. - RVT/CVT/LVT or LAT certification preferred The hourly range for this position is between $28/hour and $30/hour. Please note that salaries vary within the range based on factors including, but not limited to skills, certifications and locations. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231066

Soaring above the ordinary, the IMPACT Fly Team is a powerhouse of innovation, precision, and technical mastery. As Major Project Automation & Controls Technicians, you're the architects of efficiency-engineering smarter systems, optimizing workflows, and tackling high-stakes challenges with finesse. Whether troubleshooting on-site or designing groundbreaking solutions, this elite squad is always ready to fly in, fix, and revolutionize. Ready to take your expertise to the next level? Because IMPACT is more than a name-it's a mission. 🚀 What we offer Competitive salary Paid vacation/holidays/sick time - 10+ days of vacation first year Comprehensive benefits package including 401K, medical, dental, and vision care - Available day one Extensive product and on the job/cross training opportunities With outstanding resources Encouraging and collaborative team environment Dedication to safety through our Zero Harm policy Check us Out: A Day in a Life at Johnson Controls: What you will do As a senior level team member of the iMPACT Fly Team, you will be responsible for traveling 75-100% of the time to and assisting JCI Customers at all levels of building automation system programming, checkout and commissioning. This will include validating hardware and software commissioning activities for building automation systems. You will need to apply your advanced HVAC & Building Automation experience to work on assigned projects. You will work directly on multiple project teams to assist the Project Managers and Field Technicians. How you will do it Loads system-level controller software Performs advanced commissioning and system diagnostics from system-level controllers to end devices (such as: sensors, actuators, etc.) and completes all required commissioning documentation Keeps management and JCI contractor or customer informed of job progress and issues Calibrates systems requiring basic electronic test equipment Completes administrative tasks including but not limited to time sheets, expense reports, and on-site documentation Documents changes and provides information for as-built documentation Communicates with the JCI contractor or customer upon arrival and before leaving the work site Follows all safety standards and attends required safety training. High degree of regard to employee and subcontractor safety. What we look for Advanced computer skills (Metasys preferred) Advanced knowledge of electrical testing and commissioning tools Strong documentation acumen Good communication and listening skills Advanced knowledge of mechanical HVAC systems Low voltage/120-volt wiring skills preferred A valid driver's license, with no major or frequent traffic violations HIRING HOURLY RANGE: $31- $42 (Hourly rate to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.) This position includes a competitive benefits package. For details, please visit the Employee Benefits tab on our main careers page at *************************************** Johnson Controls International plc. is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability or any other characteristic protected by law. To view more information about your equal opportunity and non-discrimination rights as a candidate, visit EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please visit here.

The Quality Control Data Reviewer I is responsible for the accurate and timely review of analytical data generated in the QC laboratory. This entry-level role ensures all documentation meets regulatory, internal, and client requirements in support of pharmaceutical product development and manufacturing. The Data Reviewer I will verify compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and related company standard operating procedures (SOPs), state, FDA, local laws and international (e.g., EU, Chinese, Japanese) as applicable to maintain data integrity across analytical activities. Duties/Responsibilities: Perform thorough review of analytical chemistry testing data for completeness, accuracy, and compliance with SOPs, test methods, and applicable regulatory standards. High-performance Liquid Chromatography (HPLC) Gas chromatography (GC) Dissolution Integrated Software Empower 3. UV-Vis Spectrophotometer Mastersizer 3000 for Particle Size Distribution (PSD) Karl Fischer (KF) pH Data Review of Analytical Chemistry Testing: Raw Material (RM) including API (active pharmaceutical ingredients) and excipients In Process (IP) Testing Clinical Verification Packaging Material Components Review the data to Comply with GLPs, cGMPs, and GDP (Good Documentation Practice). Confirm that calculations, units, and transcriptions are correct and traceable. Ensure chromatographic integrations and results are scientifically sound and compliant with established protocols. Verify that all test methods and procedures are properly followed and documented. Identify, document, and escalate any data discrepancies or deviations for investigation. Maintain a thorough understanding of current USP, EP, and ICH guidelines related to QC testing. Support audit readiness and participate in internal/external audits as needed. Collaborate closely with analysts, supervisors, and QA to resolve issues and ensure timely batch release. Maintain good documentation practices (GDP) and support data archival processes. Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP to increase efficiency, compliance, and Quality. Review analytical data to ensure ALCOA+. Ensure compliance of testing with laboratory procedures, test methods, and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus, and multitask on review of analytical laboratory data. Adhere to the Safety and Health Program and associated plans. Review time of use logs on cGMP instrumentation and other analytical equipment. Completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks. Knowledge of QA events/deviations/Investigations. Any other responsibilities are assigned by the manager or department head. Required Skills/Abilities: Demonstrates excellent personal organizational skills Knowledgeable in Pharmaceutical industry regulations Health and Safety Awareness Must work as a team member in the QC Lab environment Education and Experience: Bachelor's degree or higher, in Chemistry, Pharmacy, Sciences, or Quality (QA/QC), or equivalent work experience 0-3 years of relevant work experience in Quality Assurance/Data review of Chemistry QC in the pharmaceutical industry. Experience in all areas of Pharmaceutical, e.g., CMO, CDMO, Clinical and commercial products is preferred. Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project, Proofreading skills, etc. Knowledge of Quality Management Systems such as Master Control. Knowledge of current federal, local, and international regulations regarding the Testing, production, and release of drug substances and products. · Basic understanding of analytical techniques (e.g., HPLC, GC) and laboratory data documentation requirements. · Familiarity with cGMP, GLP, and regulatory compliance standards (FDA, EMA, ICH). · Proficient in Microsoft Office (Word, Excel, Outlook); experience with electronic laboratory systems (e.g., Empower, LIMS, LabWare) is an advantage. · Strong communication, organizational, and time management skills. Ability to manage multiple priorities and re-prioritize tasks as required. Strong attention to detail and ability to detect data inconsistencies. Excellent problem-solving skills. Physical Requirements: • Fluent in English • Ability to travel between and within facilities to visit staff, operations, projects, etc. • Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). • Ability to lift up to 40 pounds on occasion. • Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). All job requirements in the provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

As the Director of Global Marketing (Nephrology & Immunology), you will transform science into strategy by driving global brand strategy, influencing launch preparations and execution, and forging connections across the enterprise **. This role is responsible for the launch of a first-in-class monoclonal antibody within the Nephrology & Immunology portfolio** . A successful candidate must be a strong matrix leader, good communicator and well-rounded global commercial leader, with proven results in shaping and implementing brand strategy, creating and delivering impactful and innovative Global programs to excel performance across the Globe. Clear strategic thinking with the ability to lead and demonstrate passion for the brand is required. You'll join an empowered, fast-paced, high-visibility team at the forefront of scientific innovation, where your work will shape decisions that impact patients worldwide with autoimmune and rare diseases. **Responsibilities:** + **Global Launch Leadership & Market Preparation:** Lead cross-functional global launch planning, ensuring alignment across R&D, medical affairs, market access, and regional teams. Drive pre-launch excellence by preparing priority markets with tailored strategies, tools, and stakeholder engagement plans. Develop and execute global launch readiness frameworks, including asset-specific launch excellence scorecards and KPIs. Ability to manage a significant scope of responsibility including multiple indication launch plans and new assets. + **Global Congress & KOL Strategy:** Design and implement a global congress strategy that elevates scientific presence and brand visibility. Build and execute a global KOL engagement plan to cultivate advocacy, shape perception, and inform strategy. Partner with medical affairs to align scientific narratives and ensure consistent messaging across touchpoints. + **Strategic Asset Development & Lifecycle Planning:** Influence target product profiles and indication prioritization with a sharp eye on market differentiation and commercial viability. Co-chair the product development committee with R&D. Shape lifecycle strategies that maximize long-term value, from pre-launch through post-market expansion. Inform the annual Global Asset Planning Process and present to senior leadership. + **Cross-Functional & Regional Collaboration:** Serve as the strategic integrator across global and regional teams, ensuring seamless execution and shared accountability. Facilitate enterprise-wide alignment through structured planning processes and transparent communication. Lead Launch Readiness Reviews with regions as well as Global Brand Team meeting with regions around the globe. + **Budget & Resource Stewardship:** Own global marketing budgets for assigned assets, ensuring strategic investment and ROI-driven execution. **Qualifications** + 10+ years in pharmaceutical or biotech marketing, with deep experience in launch strategy and pre-launch planning, global preferred + Proven success leading cross-functional teams through late-stage development and global commercialization + Expertise in global congress planning, KOL strategy, and market readiness frameworks. + Strong strategic thinking, business case development, and stakeholder influence. + Experience in Nephrology, Immunology, or autoimmune therapeutic areas preferred. + Undergraduate degree in marketing, science, or business required; advanced degree (MBA, PharmD, PhD, MD) strongly preferred. + Location: Remote, with ability to be in Princeton, NJ for moments that matter + Willingness to travel up to 30% globally. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job DescriptionBenefits: 401(k) Company parties Competitive salary Flexible schedule Free uniforms Health insurance Training & development Benefits/Perks Competitive Compensation Great Work Environment Career Advancement Opportunities Job Summary We are seeking a Physical Therapy Aide/Tech to join our team! As a Physical Therapy Tech, you will be working closely with our Physical Therapists and other providers, as well as patients each day to assist them as they exercise or practice daily tasks, motivate and encourage them, and correct their posture or form as needed. You will also be recording accurate patient records, setting up all needed equipment and tools for each patient, and maintaining a clean, safe work environment. The ideal candidate works well both independently and within a team, can maintain a positive attitude to encourage patients in recovery, and has existing knowledge of physical therapy guidelines and recommendations. Responsibilities Assist patients as they exercise or practice daily functional tasks by correcting form, motivating them, and ensuring their safety Review and administer individualized treatment plans for each patient Maintain accurate records for all patients, their treatment, and their progress Assist patients using support devices, such as a walker, cane, or wheelchair Mentor and encourage patients going through major life changes, providing positive support, encouragement, and simple advice for their daily lives Maintain all equipment, ensuring a clean, safe work environment Qualifications Excellent communication and interpersonal skills The ability to create a positive, nurturing environment The ability to work well and make decisions in a high-stress environment

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. **Job Summary** We are seeking a **Repository Specialist** for our **Insourcing Solutions** team based at our facility in **Frederick, MD** . As the **Repository Specialist** , you will receive, handle and inventory specimens of human, animal and/or plant origin at temperatures ranging from ambient to -195°C, as well as weigh and prepare samples for pickup, courier delivery and shipment. Additionally, you will be tasked with maintaining repository files for validation of data and preparation of reports, as well as review accumulated data for accuracy and prepare reports of information and sample data. Additional responsibilities include: + Assemble and display data for the storage and retrieval of specimens and for report preparation. + Perform freezer inventories, as well as operate and freeze specimens utilizing controlled-rate freeze equipment. + Participate in temperature/liquid nitrogen (LN2) liquid level monitoring and emergency response rotations. + Process and aliquot specimens. + Enter data into client's online repository database for sample tracking and inventory management. + Driving client vehicle to deliver and pick-up specimens locally. **Job Qualifications** The following are minimum requirements related to the **Repository Specialist** position: + High School Diploma or equivalent + Valid driver's license + A minimum of two years related office and administrative experience preferred + Experience working in a shipping/receiving environment with scientific data preferred An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. The pay for this position is $20.00 per hour. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231136

Job Description What We're Looking For: Santé is seeking a Full Time Psychotherapist to join our team servicing clients throughout Montgomery County, MD. As a therapist, you will provide a variety of psychotherapies to home-bound older adults and seniors in the Montgomery County community. This is a salaried position. Provide individual and group therapy. Provide services utilizing the Recovery Model. Responsible for the timely development and submission of all case documentation in the Electronic Medical Record (EMR). Coordinate treatment with internal and external team members and community partners. What We Require: Master's Degree in Counseling, Social Work, or related field. Current clinical licensure in the State of Maryland - LCSWs and/or LCPCs Valid driver's license with proof of current automobile insurance and your own vehicle. What You'll Get: Salary Range: $80,000 - $85,000 annually + we provide mileage reimbursement and annual budget for professional development! Comprehensive benefits package including medical, dental, vision insurance, and more! 401k and 403b Retirement plans available. Opportunities for career growth, training and development, flexible work schedules and shifts. Paid Parental leave. The rare opportunity to make a difference in the very community that you call home. Smart, passionate, and engaged coworkers. We believe that diversity of background and experience makes for better problem-solving and collaboration, which is why we are dedicated to adding new perspectives to the team. Even more important than your resume is a positive attitude, a passion for making an impact, a personal desire to grow, and the ability to help individuals heal, recover, and thrive. Disclaimers: The Santé Group aspires to create an organization that places value on collaboration, innovation, creativity, and inclusiveness. To achieve this success, it is essential that all members of our organization feel secure, welcome, and respected. All members of our organization have a responsibility to uphold these values. The Santé Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability status. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. The Santé Group participates in E-Verify. **************************************************************** #LI-SC2