Impulse Dynamics jobs in Santa Barbara, CA

Alpine Health is a pharmaceutical distributor that supplies independent pharmacies with a full range of Generic Rx drugs, Diabetic Supplies, DME and Home Health Care products, Prescription Vials and Bottles, Pharmacy Supplies and Health and Beauty Aid Products. We are seeking a motivated and dynamic Field Sales representative to join our teaming the pharmaceutical industry. The role is ideal for an individual passionate about healthcare, with an interest in sales, who is ready to make a positive impact promoting our products to healthcare providers across the country. As a Field Sales Representative, you will be responsible for building and maintaining relationships with healthcare professionals, understating the customers needs, and educating clients on our products. Key Responsibilities: Sales and Relationship Building: Develop and foster strong relationships with healthcare professionals, including doctors, pharmacists, and other key decision makers. Conduct product presentations, detailing sessions, and regular follow-ups to promote product adoption. Product Knowledge and Education: Gain and maintain in-depth knowledge of our product line, therapeutic areas, and industry trends. Provide accurate information and guidance to customers our products, demonstrating a high level of expertise. Customer Engagement: Identify and understand the customers needs through active listening and research. Leverage the customers feedback and market insights to help tailor approaches and messaging. Territory Management: Manage a diverse territory that includes nationwide accounts and potential customer sites. Plan and execute travel schedules to ensure comprehensive territory coverage. Maintain a regular travel scheduled to various locations, adapting to new markets and clients. Reporting and Administration: Track and report daily activity, sales and client interactions using CRM software. Provide feedback management on market trends, client needs, and competitor activity. Prepare weekly and monthly reports on territory performance and areas for improvement. Qualifications: Bachelor's degree in Life Sciences, Business, Marketing, or a related field. Previous experience in sales, customer service, or healthcare (internships or entry-level positions) preferred. Strong communication, presentation, and interpersonal skills. Ability to work independently, adapt to new environments, and demonstrate resilience. Willingness to travel extensively (up to 80%) across the country. Valid driver's license and ability to meet travel requirements for this position. What we offer: Competitive base salary with performance-based incentives. Comprehensive training program on all our products, sales skills, and industry regulations. Reimbursement for travel expenses and equipment provided. Job Types: Full-time Education: Bachelor's (Preferred) Experience: 1 year Outside Sales Salary: $55,000-$60,000

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Base Salary: $150K USD + Bonus | Full-Time | Remote Globally recognized, publicly traded full-service CRO that's redefining clinical research across continents. With a footprint in over 30 countries and a workforce of 10,000+, this organization partners with thousands of biopharma and medtech innovators to bring cutting-edge therapies to market. From oncology to rare diseases, their pipeline is as diverse as their team. Leveraging AI-powered platforms and real-world data, they're not just conducting trials-they're shaping the future of medicine. If you're a Clinical Project Manager looking to lead global studies in a collaborative, tech-forward environment, this is your chance to thrive. Key Responsibilities Lead and manage global Phase I-IV clinical trials across cardiovascular and oncology indications Oversee cross-functional teams including biometrics, regulatory affairs, medical writing, and pharmacovigilance to ensure seamless trial execution. Develop and maintain project timelines, budgets, and risk mitigation strategies. Serve as the primary point of contact for sponsors, vendors, and internal stakeholders. Ensure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements. Utilize AI-enabled tools and platforms to optimize trial design and operational efficiency. Contribute to business operations including budgeting, forecasting, and resource planning. Mentor junior team members and foster a culture of excellence and innovation. Qualifications Minimum 10 years of experience in clinical research, with at least 6 years as a Clinical Project Manager. Must have direct experience managing both cardiovascular and oncology studies. Experience across multiple phases, preferably Phase II-III. Global trial management experience is essential. CRO experience strongly preferred. Strong understanding of drug development processes and clinical trial regulations. Valid and current GCP certification required. Solid knowledge of local regulatory requirements in the U.S. and/or EU. Proven experience in budgeting and business operations related to clinical project management. Excellent communication, leadership, and problem-solving skills. If you or someone you know fits this experience and shows interest, we'd love to speak with you!

YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! As directed by the RF system the Pick Pack Operator will manually pick, pack, and process containers (consisting of various materials and products). Full Time Opportunity based out of Lakewood, NJ Distribution Center Must be able to work the hours of 7:30am- 4:00pm ET. Responsibilities Maintains a safe work environment at all times. Reports any unsafe issues to Supervisor immediately. Maintains a clean work environment at all times in accordance with sanitation standard operating procedures. Reports any sanitation issues to Supervisor immediately. As directed by the RF system; pick container/s according to customer's specifications All steps are initiated by way of RF scanning; Item numbers, pick locations, and quantities. The user is expected to verify these steps in the RF device as part of the picking process. Simultaneously pick & begin packing these container/s to prepare them for shipping Add packing materials to prepare container/s for final shipping process. Ship packages using RF and various computer systems. Maintains inventory levels in pick module as required and performs stock put-away work as required. Performs scheduled cycle counts as directed. Operates equipment including, but not limited to; RF scanners, case sealers, scales, postage machines, and computer stations. Qualifications High School Education or GED One year related experience or training; or equivalent combination of education and experience. General knowledge of RF equipment General warehouse or distribution skills Use of job specific machinery and equipment Basic mathematical skills (counting, adding, multiplying) Basic computer skills Frequently lift and/or move objects up to 35 pounds. Occasionally lift and/or move objects up to 60 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knipper Health is an equal opportunity employer.

Data Analyst Department: Client Operations Reports to: EVP, HUB Operations FLSA: Exempt The Corporate office operating hours are Monday through Friday 8:30 am - 5:00 pm EST. Primary Function: The incumbent is responsible for the data outreach, data capture/loading, and data reporting per specific program requirements. Job Scope and Major Responsibilities: Reach out to member pharmacies to gather missing data, clarify data inconsistencies, and offer technical assistance/expertise if necessary Identify, investigate, and resolve data anomalies using SQL or other statistical analysis software Ensure that Asembia's data reports meet program requirements and are delivered in a timely manner by making necessary changes to improve data accuracy Process daily/monthly/quarterly master data functions as assigned Provide ad hoc data analysis to internal and external parties as requested Append pharmacy data reports to the Asembia database using applicable data rules to ensure quality of input through various stages of the data-loading process. Communicate findings of data investigations and manage expectations for internal and external stakeholders The timely submission of accurate data to appropriate parties. Maintaining a high level of customer service for Asembia's customers - manufacturers and members' pharmacies. Successful collaboration with other Asembia team members to attain a common goal. Attendance and schedule adherence is critical. Adhering to company policies and procedures. Possess a professional demeanor, focused on respectful communication, a positive and reliable attitude, and responsible behavior. This includes dressing appropriately, being punctual, maintaining composure, and demonstrating accountability for your actions. Working outside of core business hours may be required. Other duties as assigned. Compliance with the provisions of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended (“HIPAA”). Qualifications: Bachelor's Degree required. B.A./B.S. Information Systems or similar field preferred. Minimum 2 years of experience working with pharmaceutical data in a team-driven environment Advanced Excel skills (building Macros, pivot tables & pivot charts, writing formulas, etc.). Proven track record with taking ownership of data investigations and seeing them through to resolution, preferably using SQL or other statistical analysis. The candidate must have client-facing experience and be able to articulate themselves clearly and concisely in their verbal and written communications. Excellent presentation and collaboration skills. Reliable and consistent attendance and schedule adherence is required. Asembia is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, natural origin, ethnicity, religion, gender, pregnancy, marital status, sexual orientation, gender identity and expression, citizenship, genetic disposition, disability or veteran's status or any other classification protected by State/Federal laws .

Alpine Health is a pharmaceutical distributor that supplies independent pharmacies with a full range of Generic Rx drugs, Diabetic Supplies, DME and Home Health Care products, Prescription Vials and Bottles, Pharmacy Supplies and Health and Beauty Aid Products. Job Description: This person will be assisting the Outside Sales Representatives with their accounts as well as developing and calling on new accounts by means of both tele-sales and relationship development. Our ideal person must be highly self-motivated, enjoy working with people in a team environment with the ability to work cross-functionally. Hours for this position are from 9:30 AM to 6:30 PM. This is a 1099 position. Excellent communication skills. Highly skilled at speaking with customers on the telephone and able to produce high quality work with little oversight. Place between 80 to 100 outgoing sales calls by phone each day to prospective clients. Document each communication and create a new, dated follow-up task in our CRM system immediately following each communication. Impeccable attention to detail in tracking leads. Participate in brief sales meetings with other Sales Reps and Sales Manager each day. Consistently meet and exceed goals while maintaining the highest level of integrity. Continuous interaction and communication with Sr. Sales and Management to keep updated of upcoming programs and changes. Ability to handle all questions and solve problems with the highest levels of skill. Sharing best practice skills with the team and to promote a positive team environment. High volume of outbound/inbound phone calls per day. Cold calling and lead generated calls. Key Attributes: Exceptional outgoing and energetic personality. Team Player with a sense of group value. Must consistently and aggressively drive sales. Self-confident and extremely competitive. Trustworthy and prideful in their work. Expert sales skills and ability to lead and motivate by example. Qualifications: Minimum 1-3 years of related experience in Business to Business (B2B) Inside Sales or New Business Development. Proven track record in new sales development. Strong planning, problem-solving, and negotiation skills. Excellent oral and written communication skills. Microsoft Suite experience. Job Type: Full-time Pay: $25.00 per hour

The Document Control/QA Specialist will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols, ensuring compliance with internal and regulatory standards. Key Responsibilities: • Manage validation documentation in automated systems, including document control and archiving. • Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports. • Collaborate with the CQV and engineering teams to ensure documentation aligns with project milestones. • Assist in audits and inspections by providing necessary documentation. • Ensure all document control activities comply with FDA, cGMP, and internal quality standards. Requirements Qualifications: • Bachelor's degree in Life Sciences, Engineering, or related field. • 8+ years of experience in document control and quality assurance in pharmaceutical settings. • Expertise in validation documentation management and quality review processes. • Strong understanding of regulatory requirements, including FDA and cGMP. • Excellent attention to detail and organizational skills. • TOP review and compilation

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Job Description Develop initial or update safety signal detection and management documents for global developmental and marketed products to support and enhance appropriate signal detection activities and robust safety evaluation Review and/or develop relevant epidemiology sections and/or papers for relevant conferences and/or peer-reviewed journals as assigned Develop or support development of instruments for epidemiological assessment strategies and safety surveillance in coordination with Biostatistics Participate in plan/design, execute or contribute to development of observational studies and interventional studies for assigned global developmental and marketed products Develop epidemiological assessment and safety surveillance plan for assigned projects or studies Review epidemiology data in supporting the development of risk management plan/risk evaluation and mitigation strategies (REMS) and other safety related documents Contribute to the design, implementation, and management of safety studies and clinical trials Search and review epidemiological data and safety literature in supporting development of Ad hoc or regular safety submissions Accountable for epidemiology sections of investigator's brochures, risk management plans, aggregate safety reports (DSUR and PSUR), and responses to health agency's inquiries for global development and post-marketing products Perform safety data evaluation and risk assessment for assigned drug products Provide or contribute to the materials used for Safety meetings including but not limited to the Clinical Safety Team, Data Monitoring Committee, Global Safety Data Monitoring Committee, Data and Safety Monitoring Board (DSMB) Contribute epidemiology input to GST Working Group meetings, Signal Detection meetings and other Global Drug Safety and Evaluation Center (GDSEC) meetings as assigned Performs other departmental duties as assigned Qualifications Education: Graduate degree (PhD, MD, MS, MPH) in a relevant field is required: Doctoral degree with at least 2 years of industry experience, academia, and/or regulatory agency Master's degree with 6+ years of experience in a national/local public health agency, regulatory agency, biopharma, and/or the medical device industry (including at least 1 to 2 years of biopharma or medical device industry experience) Professional Experience: Experience and training in public health, pharmacy, health services research, health outcomes research, epidemiology, biostatistics or other relevant fields Familiarity and experience with the development and implementation of epidemiology research strategies Expertise in Biostatistics, Epidemiology/ secondary database analyses (e.g., claims, national survey data, etc.), Psychometrics Demonstrated experience as a member of a product or project team Experience in scientific writing of peer-reviewed, academic and/or public health literature Familiarity with Drug Development and Phase 1-4 clinical trials Knowledge and Skills: Strong understanding of research methodology and statistics, as well as strong technical writing, and strong ability to critically review published scientific literature Strong verbal and written communication, presentation skills, including experience Critical thinking and problem-solving skills, ability to set priorities and develop strategies/studies to answer complex research questions Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines Ability to analyze and interpret safety data Good understanding of advanced design and analysis techniques used in the analysis of secondary data (e.g., matching, multivariate regression, meta-analysis, etc.) Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans) Working knowledge of 2 or more secondary database types (e.g., claims, surveys, electronic medical records) Working knowledge/ability to use standard statistical packages (i.e. SAS, STATA, etc) Ability to contribute to written processes to ensure consistent and quality deliverables Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

1. Equipment & Facility Maintenance Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers. Implement robust Preventive Maintenance (PM) and predictive maintenance programs. Conduct breakdown investigations and implement corrective actions. Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards. 2. Regulatory Compliance & Documentation Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements. Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs. Support internal and external audits (FDA, DEA, ISO, and customer audits). 3. Utilities & HVAC Systems Management Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems. Ensure qualified and compliant environmental controls for classified OSD manufacturing areas. Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems. 4. Equipment Qualification & Validation Work with Validation and QA teams on IQ/OQ/PQ protocols. Manage requalification schedules and ensure equipment remains in a validated state. Provide engineering assessments for change controls. 5. Safety, Risk Management & Compliance Ensure adherence to OSHA, NFPA, and site safety requirements. Implement safety programs including LOTO, confined space, hot work, and electrical safety. Conduct incident investigations and lead corrective actions. 6. Spare Parts & Vendor Management Maintain optimum inventory of critical spare parts. Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs. Evaluate and onboard modern technologies and suppliers. Qualifications & Experience Education: Bachelor's degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent). Preferred: Master's degree or certifications such as CMRP or PMP. Experience: 8-15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing. Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems. Experience with FDA/DEA audits and equipment validation. Must have a valid work permit.

YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! As guided by management, Utility Associate perform various duties in support of Operations, Production, Distribution, and Warehouse areas. These duties may include, but are not limited to; sorting, counting, palletizing, stacking, wrapping, and moving various materials by hand or with the use of light machinery. Full Time Onsite role based out Lakewood, NJ Distribution Center; Must be available to work the hours of Monday- Friday 7:30am ET- 4:00pm ET. Responsibilities Maintains a safe work environment at all times. Reports any unsafe issues to Supervisor immediately. Focus on quality and accuracy as part of the company wide goal: Quality First Display: Caring, Honesty, Accountability, Respect, and Trust (CHART). Maintains a clean work environment at all times in accordance with sanitation standard operating procedures. Reports any sanitation issues to Supervisor immediately. Participate in user training that is led by qualified staff members that will include but is not limited to: hands on the job training, Warehouse Management System (WMS) navigation, and Standard Operating Procedures (SOP) training. Said trainings are documented accordingly. Able to work in various temperature ranges such as freezers, refrigerated, and ambient for extended periods of time. Operate equipment including, but not limited to; RF scanners, pick to light technologies, carton sealers, scales, postage machines, pallet wrappers, and computer stations. Along with WMS functions; other software applications such as UPS, FedEx, USPS, and shipment End of Day processes will be used daily. Can be expected to work within various areas of Operations and Distributions such as: Receiving, assorted pick modules, Kitting, Shipping, Returns, refrigerated space, DEA, and Small Order Distribution (SOD). Use of light equipment such as pallet pump jacks and dollies to relocate goods and supplies. Qualified individuals will be certified in other equipment usage such as electric pallet jacks, counter balance forklifts, and floor scrubbers. Locates and delivers material for departments in accordance with the daily needs and schedules as directed by management. Uses designated systems and software to perform various tasks as directed by management. Physically moves material and systematically locates as directed by management. Expected to assist with the training of new employees. Perform other assigned tasks as directed by management. The above duties are meant to be representative of the position and not all-inclusive. Qualifications Education/Training: High School Diploma or GED or equivalent experience Business Experience: One year related experience or training; or equivalent combination of education and experience. KNOWLEDGE, SKILLS & ABILITIES: General warehouse or manufacturing skills. Use of material handling equipment including pallet jacks (both manual and electric), stretch wrappers, and scales. General ability to operate machinery. Basic math skills. PHYSICAL DEMANDS: While performing the duties of this job the employee is frequently required to: stand or sit stoop, kneel, or crouch reach with hands and arms work in refrigerated conditions lift and/or move objects up to 35 pounds and occasionally lift and/or move objects up to 60 pounds Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knipper Health is an equal opportunity employer.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. We are currently seeking a Translational Science Intern from June 2026 - May 2027. This part-time position works for approximately 20 hours per week. Responsibilities: Project Title: Multimodal foundation models for integrating diverse biological data The intern will use a multimodal AI framework to integrate and interpret diverse biological data, such as DNA sequencing, bulk RNA sequencing, single-cell multi-omics and imaging. The core objective is to use pretrained vast and diverse biological datasets to generate a holistic understanding of cellular states, gene regulation, and tissue architecture. We will demonstrate the utility of these models by applying them to a complex biomedical challenge, such as identifying novel biomarkers for cancer treatment. The project will address limitations of unimodal approaches, including noise sensitivity and incomplete biological context, by leveraging complementary and supplementary information across modalities. The models will incorporate interpretability methods to provide biological insights, foster new hypothesis generation, and accelerate biomarker discovery. The focus is on technology evaluation and development to explore the latest methods out there and not limited to autoencoder, foundation model/transformer and graph neural network (GNN). In scope is the comparison with other conventional approaches for predictive biomarker discovery and patient subgrouping tasks. Goals and Deliverables The intern will be responsible for the following: 1. Literature Survey and Method Curation Conduct a structured review of recent ML/AI methods (published within the past 2-3 years) focused on biomarker discovery, subgroup and clinical efficacy prediction. Categorize methods by approach (e.g., deep learning, ensemble learning, survival analysis, multi-omics integration) and application area. 2. Prototype Implementation and Benchmarking Implement selected methods using internal or publicly available clinical datasets (e.g., TCGA, CPTAC). Compare performance using standard metrics (e.g., AUROC, concordance index, time-to-event analysis). 3. Pipeline Development Wrap up the development as a deployable package with easy-to-use configurable command line interfacing or notebook and provide user documentation. Ensure compatibility with internal data structures and analysis frameworks. 4. Reporting and Knowledge Transfer Deliver a final report and presentation summarizing findings, learnings, recommendations, and reproducible code. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $17.23 - $58.15 Download Our Benefits Summary PDF

EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan's most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson's (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPA's commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA (edaravone) injectables in 2017 and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. Job Description Direct Hire Opportunity! The Senior Director, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the Senior Director Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role. Responsibilities Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US' lead Parkinson and ALS products Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject matter expert from a Market Access perspective for 340B program and other government programs. Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function Effectively manages budgets and project timelines including contract management Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate Develop account metrics against strategic, financial, and product access KPI's Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business. This is a home office based position. The expectation is to be in the office 3 days a week. Qualifications Bachelor's Degree Required, Masters preferred Must have 15 plus years within the pharmaceutical industry and 10 years' experience in Distribution, Account Management or Aligned Market Access functions. Experience with distribution for early-stage pipeline programs Experience in Federal Markets including VA, Department of Defense and 340B Program preferred. Device/Drug combination strongly preferred Minimum 5 years of people management experience required Track record of closing complex negotiations within the specialty pharmacy arena Preferred experience includes: All aspects of distribution Launch and life cycle management for the distribution process Experience in Market Access marketing History of successful negotiations Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions Firm grasp of legal, regulatory and compliance issues in the healthcare space Analytical/strategic thinker with proven ability to: conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans understand the best pathway for distribution based on the product and its attributes conduct strategic gap analysis and implement metric-based solutions Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget Highly proficient in MS Office; advanced Excel skills Must be able to travel domestically and internationally (approximately 40%) Additional Information Mitsubishi Tanabe Pharma America Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits. MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

Job Title: Digital Consumer Experience Design About the Job Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve. About Sanofi EDGE: Sanofi EDGE - Building a Healthier Future, Together At EDGE, we're revolutionizing how individuals manage their health and well-being. We believe that lasting health behavior change is best achieved through a supportive ecosystem that includes not only clinical guidance but also the encouragement and practical assistance of a user's care circle. Our platform empowers individuals to set meaningful health goals, track their progress, and connect with their support network, all grounded in evidence-based principles and a deep understanding of human motivation. We're a passionate team dedicated to creating a user-centered experience that drives meaningful health outcomes and fosters long-term engagement. The Opportunity: We are seeking a talented and passionate UX/UI Designer to join our growing product and experience team. As a key member of the team, you will play a crucial role in shaping the user experience of our health management platform. You will be responsible for translating user needs, business requirements, and strategic goals into intuitive, engaging, and effective design solutions. You will collaborate closely with product managers, engineers, and researchers to create a seamless and empowering experience for our users and their care circles. Ideally, you will bring experience designing for consumer health applications, understanding the unique challenges and opportunities within this space. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Lead and contribute to the end-to-end design process, including detailed UI specifications and visual design. Develop a deep understanding of our users, their motivations (in formed by self-determination theory), and their care circle dynamics through user research, usability testing, and data analysis in collaboration with product and user research team members. Create user flows, wireframes, prototypes, and high-fidelity mockups that effectively communicate design ideas and solutions. Design intuitive and accessible user interfaces that are consistent with our brand guidelines and design system. Collaborate closely with product managers to define product features and translate them into user-centered design solutions. Work effectively with engineering teams to ensure the successful implementation of designs. Participate in design reviews and provide constructive feedback to other team members. Stay up-to-date with the latest UX/UI trends, best practices, and technologies, particularly within the digital health landscape. Contribute to the evolution and maintenance of our design system. Advocate for the user throughout the product development lifecycle. About You Qualifications: Bachelor's degree in Design, Human-Computer Interaction (HCI), or a related field, or equivalent professional experience. Proven experience (ideally 3+ years) as a UX/UI Designer, preferably with experience in consumer-facing digital products. Strongly preferred: Experience designing for consumer health applications, with an understanding of health data privacy (e.g., HIPAA), accessibility standards (e.g.,WCAG), and user behavior in health management. A strong portfolio showcasing user-centered design solutions and demonstrating a clear understanding of UX principles and UI best practices. Proficiency in industry-standard design and prototyping tools (e.g., Figma, Miro, Adobe XD). Excellent communication, collaboration, and presentation skills. Ability to work independently and as part of a cross-functional team in a fast-paced environment. A strong understanding of user-centered design methodologies and the ability to translate research insights into actionable design decisions. A passion for improving people's lives through thoughtful and effective design. Familiarity with agile development processes. Bonus Points: Experience designing for behavior change or social support platforms. Knowledge of self-determination theory and its application in digital product design. Experience working with design systems. Understanding of front-end development principles (HTML, CSS, JavaScript). Experience using AI to create workflow efficiency To Apply: Please submit your resume and a link to your online portfolio showcasing your relevant work. In your portfolio, please highlight projects that demonstrate your user-centered design process and your ability to solve complex design challenges. If you have experience in consumer health, please specifically call out those projects. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $208,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

Achieve territory sales goals by promoting products and services to physicians and other medical personnel within assigned geography. Educate customers on the appropriate use, characteristics, and approved indications of products. Professionally represent the company and ensure high levels of visibility and customer service in territory. Maintain effective communication and relationships with key external and internal customers. Responsibilities Effectively promote and educate specialty physicians on the appropriate use of rare disease products through one-on-one meetings and group presentations, company-approved promotional speaker programs and other company-approved means. Responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics. Ensure high performance levels of call and field productivity. Meet territory product sales goals while adhering to all defined ethical sales practices, compliance guidelines and required promotional regulations Execute company-approved Product Marketing plans and territory/regional business plan activities Support targeted customers and accounts using company-approved resources, sales materials and promotional activities/programs/initiatives as identified by Sales Leadership Appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company compliance guidelines Ensure optimum territory sales strategy execution using territory business plans, regional business plans and all appropriate sales reports Communicate cross-functionally to gather knowledge of best practices from peers within the organization. Attend all company-sponsored sales and medical related meetings as directed by company management. Actively pursue continuous learning and professional sales development on effective sales/communication techniques and product/therapeutic area knowledge. Qualifications BA/BS required 5-7+ years of successful pharmaceutical sales experience required. Previous experience in competitive markets preferred Proven record of sustained high sales performance and achievement (Top 10%, National Awards) 2+ years of experience promoting rare competitive disease products strongly preferred A valid, US State-issued driver's license is required Launch experience or start-up experience is a plus Experience working with Endocrinologists preferred Deep understanding of all stakeholders in an office and ability to support them in getting a patient started on therapy within guardrails established by the company Demonstrated ability to both build relationships within existing accounts as well as proactively find new accounts Previous experience working with specialty pharmacies and internal patient support roles preferred Experience navigating managed care and rare disease products preferred At Xeris, performance consists of both results and behaviors. Behavioral competencies include: Leadership skills, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Adherence to compliance policies and processes, Analytical skills, Multi-Tasking skills, Decision-making skills, Accountability, Inquisitive Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Position requires vehicle travel, as necessary. Travel approximately 70%. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $110,000 to $190,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

NO THIRD PARTIES WILL BE CONSIDERED We have a 20+ year relationship with our client Long-term Contract Rates: Hourly W2 or C2C options Technical Product Owner (TPO), Enterprise Quality, Data, Intelligence & Automation Position Overview: We are looking for a proactive and results-oriented Technical Product Owner (TPO) according to the High-Performance Team (HPT) model to spearhead the end-to-end execution of Enterprise Quality's Data, Intelligent Automation, and Artificial Intelligence products and platforms as part of the Data, Intelligence & Automation (DI&A) team. The ideal candidate will play a key role in informing the product development strategy for various DI&A products and platforms, ensuring alignment with broader business strategies & overall business objectives, and delivering DI&A products that drive business value. Key Responsibilities Act as the TPO for multiple Enterprise Quality products and platforms, driving the product vision and strategy to meet stakeholder needs. Collaborate with cross-functional stakeholders (Quality Organizations, TQ, ISRM, and TS), functional product groups, and HPT chapter expert services to gather requirements, prioritize features, and deliver comprehensive analytics solutions. Define and manage the product backlog, ensuring that user stories and acceptance criteria are clear and actionable. Translate business requirements into technical specifications, working closely with data engineers and developers to ensure the timely delivery of enhancements and features. Manage the total cost of ownership (TCO) of products, drive cost optimization, and identify cost-reduction opportunities while maintaining operational efficiency Monitor platform performance, identify areas for improvement, and recommend enhancements to support informed decision-making. Conduct regular QBRs/stakeholder reviews and gather feedback to continuously enhance the product/platform's capabilities and user experience. Stay informed about industry trends and best practices in data, advanced analytics, artificial intelligence, and intelligent automation, assessing new technologies as appropriate. Lead training sessions and workshops for users to promote platform adoption and maximize its potential. Create a compelling value proposition to secure development budget, demonstrating a clear understanding of the project benefits and key results. Responsible for maintaining portfolio information in Nexus, Assess Management, Lean IX, ITSM, and IAM. JJT Lead for SOX application(s) within the scope of the role. Education: A minimum of a Bachelor's degree in information technology, Management Information Systems, Data Science, or a related field is required. An advanced degree is preferred. Experience & Skills: A minimum of 2 - 3 years in roles that create a tangible business impact through Data, Intelligent Automation, and Artificial Intelligence (including Data Science, Machine Learning, Generative AI, Agentic AI, Langflow, and other relevant technologies) is required. A minimum of 5 years of IT-related experience is required. Proven experience in digital product management, preferably in a data analytics environment, along with strong analytical skills to analyze and evaluate data and to drive appropriate recommendations and decisions for senior leaders and sponsors. Understanding of Laboratory Systems (i.e., LIMS, SDMS, etc.) and/or Quality Management Systems (i.e., QMS, Complaints, Document Management, etc.) would be considered valuable assets. Excellent communication and interpersonal skills, capable of engaging effectively with stakeholders at all levels. Experience with Agile methodologies and tools (e.g., Scrum, JIRA) is strongly recommended. Experience with several of the following technologies: Microsoft Azure, Databricks, OpenAI's GPT, Neo4j, Alation, PostgreSQL, Python, PySpark, AI-powered Business Intelligence (BI) and data visualization tools (Tableau, Power BI, ThoughtSpot) - strongly recommended. A demonstrated ability to manage multiple priorities in a fast-paced environment. Excellent written and oral communication skills, with strong interpersonal skills and a team-oriented approach. Ability to influence, negotiate, and communicate effectively with internal and external stakeholders across complex matrix organizations. THIS IS A HYBRID ROLE: 3 DAYS PER WEEK IN CENTRAL NEW JERSEY - commutable distance to central New Jersey is required.

**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Associate Specialist, Value Stream Cryo Operations is responsible for the Cryopreservation, movement, storage, control of manufacturing patient materials, and support of Liquid Nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ. This includes but is not limited to, cryopreservation, storage, inventory control, chain of custody, and material tracking. **Shift Available:** + Wednesday - Saturday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m. **Responsibilities:** + Handling patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal. + Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures. + Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures. + Performing sample queries and periodic storage reports, as required. + Assisting management with investigations and deviations related to sample management. + Collaborating with other departments to identity and implement process efficiencies. + Maintaining metrics for the Value Stream Cryo Operations group. + Facilitating cold chain transfers of material, as required. + Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). + Maintains timing according to the production schedule to ensure on-time Cryopreservation support. + Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations. + Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs. + Maintains timing according to the production schedule to ensure on-time logistics. + Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively. + Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities. + Records patient material handling data and information in a clear, concise, format according to proper GDPs. + Able to problem solve with minimal supervision. + Works in a team based, cross-functional environment to complete tasks required by shift schedule. + Other duties may be assigned, as necessary. + Available to work OT when business requires. + Willing to work staggered day shift hours. **Knowledge & Skills:** + Basic mathematical skills. + General understanding of cGMPs. + Technical writing capability. + Proficient in MS Office applications. + Inventory control and/or management + Background to include an understanding of biology, chemistry, medical or clinical practices is a plus. **Basic Requirements:** + Bachelor's degree with no prior experience. + Or associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience. + Or High School diploma/GED and 3-4 years of Manufacturing or Operations experience. + Experience with cold chain sample storage and transfer. + Knowledge of cGMP/FDA regulated industry. BMSCART, #LI-Onsite If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Compensation Overview:** Summit West - NJ - US: $31.90 - $38.65per hour The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ************************** . Visit careers.bms.com/ (****************************************** eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1596185 **Updated:** 2025-12-14 00:51:16.204 UTC **Location:** Summit West-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The Associate Director, Regulatory Affairs Strategy - Safety and Toxicology will develop and execute product safety strategies that drive business innovation while ensuring regulatory compliance. This role will provide leadership and guidance for regulatory submissions, health authority interactions, new product development, and existing product maintenance as well as overseeing raw material and formula clearance for product safety and compliance. The ideal candidate will combine strong regulatory knowledge with hands-on experience to ensure product safety over the full life cycle of a diverse portfolio of healthcare and consumer regulated products including but not limited to drugs, devices, cosmetics, surface sanitizers and disinfects. ESSENTIAL FUNCTIONS AND BASIC DUTIES Contributions * Lead Product Safety and Toxicology team in developing and executing safety strategies for new product development and maintenance of existing products to ensure successful commercialization across product life cycle * Develop and execute non-clinical safety strategies to generate pre-clinical data for new product development marketing authorization applications * Investigational/New Drug Applications (IND/NDA) * Medical Devices Pre-Market Notifications (510(k)) * Pesticides - FIFRA §3 * Develop and execute non-clinical safety strategies for qualifying impurities and new inactive ingredients * Assess non-clinical safety data and advise project teams on potential in-vitro and in-vivo clinical and non-clinical safety study requirements * Design, coordinate and monitor in-vitro and in-vivo clinical and non-clinical safety studies * Ensure studies comply with Good Laboratory Practice (GLP) standards and FDA and HC recognized regulatory guidelines * Author and review non-clinical sections of regulatory submission documents (IND/NDA/510(k)/FIFRA §3) * Prepare, oversee, and deliver raw material and formulation toxicological risk assessments, safety clearances, and Consumer Products Safety Reviews (CPSR) * Prepare, oversee, and deliver Safety Data Sheets (SDS) for drugs, devices, disinfectants, cosmetics and cleaning products * Represent Product Safety in cross-functional new product development (NPD) teams * Represent PDI at industry meetings related to safety (SOT, PCPC, HCPA) * Monitor trends, emerging regulations, guidance, and best practices (regulatory intelligence) related to safety compliance and product development * Communicate and collaborate in acting on regulatory intelligence that has potential to impact the business * Ensure products meet all the necessary Federal and State safety regulations and reporting requirements for U.S. and CA Oversee 1 direct report to: * Review, approve, and certify all formulation raw ingredients, nonwovens, packaging, and fragrances for intended use, country of launch (U.S./CA), and compliance with latest regulations and customer requirements * Generate Safety Data Sheets (SDS) by reviewing formulations and developing safety, precautionary, and first aid language * Ensure supplier compliance by updating Raw Material Information Review (RMIR), nonwoven, packaging, and fragrance requirements according to the latest regulatory and customer requirements * Obtain third party seals of approval from EPA Safer Choice, EPA Design for Environment (DfE), National Eczema association (NEA), United States Department of Agriculture Biobased (USDA), and Environmental Working Group (EWG) * Provide support for safety related claims e.g. Non-Animal Tested Declaration, Food Allergen Declaration, "Free from" Declaration * Provide support for compliance requirements (e.g. Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Safety Substantiation, IFRA 52nd Amendment (2026), Hazard Communication Standard (SDS) Updates; California CFFIRKA allergen reporting requirements) Cross-Functional Support * Collaboration: Work closely with multidisciplinary teams, including R&D, Clinical, Manufacturing, and Quality functions to integrate safety findings/plans into the overall drug development strategy, align regulatory submissions with development and operational plans, and ensure project timelines are met. * Problem Solving: Generate hypotheses and investigative strategies to address any safety concerns or unexpected findings that arise during the non-clinical phase. * Participate: in health authority interactions (FDA, Health Canada) by contributing to meeting materials and supporting response strategies. Operational Excellence * Maintain and strengthen safety documentation, templates, and SOPs to support consistent, high-quality safety assessments and strategies. * Partner with cross-functional colleagues to identify process improvements and leverage tools that enhance efficiency and accuracy in development and maintenance projects. Mentorship and Collaboration * Provide guidance and support to junior regulatory staff where applicable, sharing expertise and best practices. * Foster collaborative relationships internally and with external partners/sponsors. PERFORMANCE MEASUREMENTS * Achievement: consistent delivery of complete, accurate and on-time high-quality technical work with minimal issues * Ownership: Independent and proactive management of assigned projects to ensure complete, accurate and timely completion * Collaboration: Effective teamwork and communication across functions to achieve shared objectives * Innovation: Introduction of creative solutions and contributions to process improvements and new product ideas QUALIFICATIONS EDUCATION/CERTIFICATION * Bachelor's degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, MS) and/or CCCTO or DABT certifications a plus REQUIRED KNOWLEDGE * Solid knowledge of FDA safety regulations; experience with ex-US authorities (Health Canada) desirable * Demonstrated ability to contribute to safety strategies and regulatory submissions across multiple phases of development EXPERIENCE REQUIRED * 8-10 years of safety experience in pharmaceuticals, biotech, medical devices, or pesticides including submission experience in IND/NDA, 510(k), FIFRA §3 or equivalent SKILLS/ABILITIES * Strong organizational skills with attention to detail, quality, and timelines * Excellent written and verbal communication skills; ability to work in cross-functional teams * Excellent organizational, prioritization abilities, tracking and follow-up skills * Ability to complete projects on time and handle multiple parallel projects in a fast-paced environment * Good analytical and problem-solving abilities, communication and interpersonal, and record keeping skills * Strong attention to detail * Ability to handle multiple tasks / projects simultaneously and bring them to completion on time * Self-starter with ability to think and act independently and to make sound decisions * Fast learner with a flexible style and the ability to adjust to changing business priorities * Ability to interface with internal and external contacts at all levels * Great flexibility and ability to work well with shifting priorities WORKING CONDITIONS Environment: Corporate office with on-site R&D laboratories Work Schedule: Hybrid (4-days/week onsite, 1-day/week remote) SALARY RANGE: * $150,000 - $180,000 annually BENEFITS PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes: * Medical, behavioral & prescription drug coverage * Health Savings Account (HSA) * Dental * Vision * 401(k) savings plan with company match and profit sharing * Basic and supplemental Life and AD&D insurance * Flexible Spending Accounts (FSAs) * Short & long-term disability * Employee Assistance Program (EAP) * Health Advocacy Program PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts. At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

The Associate Director of Biosimilar Contracting Operations will play a pivotal role in shaping our biosimilar and branded 505B2 (injectable) contracting operations strategy and process within Amneal. This position entails significant influence over contract management and operational decision-making that directly impacts revenue and overall business performance. The Associate Director will oversee a team dedicated to contract operations, ensuring alignment across internal departments and external partners. The ideal candidate will have a proven track record of influencing decision-making processes and achieving revenue impact through effective customer contract operations management. The candidate will be skilled in building and maintaining collaborative relationships with internal stakeholders to ensure alignment on contracting tactics and operational execution. Strong management and communication abilities are essential, as well as expertise in cross-functional collaboration. The candidate will be responsible for articulating a clear vision and objectives, executing deliverables within timelines and adapting proactively to evolving market dynamics. The candidate's leadership will drive both team success and strategic outcomes for the organization. This position will report to the Senior Director, Biosimilar Commercial Operations and will work closely with managers and leaders across other functional areas to ensure strategic alignment with overall company and division objectives. Essential Functions: Contract Management - Responsible for creating a Center of Excellence for biosimilar and branded 505B2 (injectable) contract management by working to understand current processes and create evolved processes to enhance efficiencies. New and existing contracts require accurate drafting and redlining; Cross collaboration with multiple internal stakeholders; Weekly performance reviews with applicable guidance to the field/customers; Maintenance of pricing governance approvals, and renewal review cycles Customer Account Level Operations Management - Drive the implementation of product access strategies and oversee the day-to-day customer contract operations for key accounts, and direct clients. The candidates' decisions will directly influence revenue generation and customer satisfaction. Internal Alignment - Proactively foster collaboration with internal functional teams, including legal, compliance, finance, auditing, IT, market access, pricing, marketing and warehouse operations. Develop, refine and optimize processes and systems to ensure strategic alignment and successful execution of biosimilar contracts. Team Leadership - Manage a dedicated US-based and offshore team, provide guidance and support to drive high performance and accountability. Empower the team to excel in customer contract operations and lead a culture of continuous process and system improvements. Operational Success - Ensure timely review and distribution of contract requests through process implementation and team management; maintain accuracy in contract loads and collaborate with the Revenue team on price and rebate structures. Strategic oversight will be critical to achieve operational excellence. 3PL Management - Manage and enhance relationships with 3PL for product management to ensure timely customer setups and efficient product distribution. Conduct daily status calls to monitor shipping schedules, address challenges-such as inclement weather-and ensure prompt resolution. Collaborate closely with the field sales team to align on new and existing customer requests, guaranteeing that customer needs are met swiftly and effectively while maintaining optimal inventory management. Education: Bachelors Degree (BA/BS) relevant field (e.g. business or economics) - Required Experience: 10 years or more in Pharmaceutical/biotech contract operations, contract administration and contract management 3 years or more in Collaborating directly with legal teams and attorneys; and field sales leaders Skills: Able to rapidly develop and maintain successful relationships with leaders and decision makers most likely at C-Suite level. - Advanced Strong negotiation skills. - Advanced Able to work well under pressure and in appreciation of pre-defined and often aggressive timelines. - Advanced Excellent written, organizational and verbal communication skills a must. - Advanced Computer literate with MS Office products including PowerPoint, Word, and Excel. - Advanced Understanding or background in biosimilar pharmaceutical products. - Intermediate Leadership skills. - Intermediate Specialized Knowledge: Microsoft Office - PowerPoint, Word, Outlook, Advanced Excel skills Strong technical skills in applications such as MS Excel, MS PowerPoint, MS OneNote and other Microsoft Office suite tools The annual salary for this position ranges from $160,000-185,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. We are currently seeking an IT Deskside Intern from June 2026 - May 2027. This part-time position works approximately 20 hours per week. Responsibilities: Based out of our HQ Technology Center, the IT Deskside Interns will provide light instruction and troubleshooting to end users in the office. Primary function will be to meet and greet staff walking into the tech center, assess the nature of their visit, and either provide assistance directly or guidance on obtaining the support needed. Acts as a liaison between staff visiting the tech center and other support teams to reduce friction in solving issues or fulfilling requests. Qualifications: Enrollment in a technology or hospitality focused undergraduate degree. Technical support skills are helpful but not required. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $17.23 - $58.15 Download Our Benefits Summary PDF