Capital Area Counseling Service jobs - 77 jobs

Clinical Specialist - Children, Youth & Family Services Employment Category: Full-time Employment Type: Hourly / Non-Exempt Reports To: CYF Clinical Supervisor Benefits: health, dental, and life insurance coverage; 401K participation; paid holidays; paid YMCA family membership; vacation and medical leave Perquisites: continued education and certification opportunities; flexible work schedule; supportive team environment that promotes staff wellness and self-care *CACS is a National Health Service Corps (NHSC) and South Dakota State Loan Repayment Program approved site which can provide opportunities for student loan reimbursement. Position Description The Clinical Specialist provides mental health support services to youth and their families as a part of a dynamic team. Opportunities to serve individuals, groups, and families. Client population served dependent on agency need with consideration for clinician preference and expertise. Duties / Responsibilities: Provide mental health support services for youth and families within an integrated system of care. Work within a team including client's family, supports, school, and other community entities. Apply evidenced-based interventions according to strengths and needs of the youth/family. Utilize culturally responsive approaches in working with diverse populations. Complete comprehensive mental health assessments. Develop, implement, and regularly review treatment plans. Complete progress notes and other necessary documentation within Electronic Health Record (EHR) according to agency, state, and federal guidelines. Coordinate client care with informal and formal supports. Have knowledge of mental health diagnoses within the DSM-5-TR or its successor. Knowledge of and ability to use Motivational Interviewing skills, Stages of Change. Respond to crisis situations compassionately and appropriately. Deliver services in home, community, office settings, or wherever necessary to best meet youth/family needs. Participate and complete trainings relevant to the position, i.e. Mental Health First Aid. Attend and participate in regular department meetings and supervision sessions. Other relevant duties as assigned. Required Skills / Abilities: Ability to organize and prioritize daily schedule based on clients needs. Adhere to HIPAA guidelines and confidentiality. Be self-directive while also seeking clinical supervision when appropriate. Maintain electronic calendars and manage workload effectively. Demonstrate effective communication and organizational skills. Establish and maintain effective working relationships with clients and colleagues. Demonstrate critical thinking and problem solving skills. Proficient in computer applications and related technology. Ability to use Outlook, Zoom, MS Teams, Excel, and electronic health records system. Meet deadlines. Follow all local, state, and federal laws. Adhere to agency code of ethics, policies, and procedures. May provide services in local or surrounding communities. May need to use personal vehicle for work-related tasks when agency vehicles are unavailable. Work hours may include some evening and weekend hours. Must have a valid driver's license and must provide proof of insurance. Education and Experience: Minimum of a bachelors degree in a human services / social sciences field with one year of relevant experience preferred. Knowledge of mental health services with willingness to further develop skills and understanding. Physical Requirements: Requires periods of moving throughout the office and traveling to other locations within the community/designated coverage area. Requires periods sitting at a desk and working on a computer. Must be able to lift up to 50 pounds at times. **REQUIREMENT FOR ALL APPLICANTS: Please include a cover letter and resume for this position. If you are unable to upload a document please enter your cover letter content in the Objective / Summary section, and your resume information in the Resume section. Please include the following in your cover letter: 1. Why you are interested in this position. 2. How your past work experience/education has prepared you for this position. **NOTICE TO APPLICANTS REGARDING WAGE RANGES: The wage or salary range listed in this job posting reflects the full compensation range established for the position. Our agency follows a structured compensation strategy to ensure fair and competitive offers aligned with each candidate's individual qualifications. The final starting wage for a selected candidate is based on a comprehensive evaluation of the following factors: Relevant years of experience Education beyond the minimum qualifications Relevant professional licenses or certifications Please note that the upper end of the salary range reflects the compensation of the most tenured and highly experienced employees in this role, based on market data within the industry. It is not intended to represent the typical starting wage for new hires. We appreciate your interest in joining our team and look forward to reviewing your application.

Genie Healthcare is seeking a travel Radiation Therapist for a travel job in Rapid City, South Dakota. Job Description & Requirements Specialty: Radiation Therapist Discipline: Allied Health Professional Start Date: 02/09/2026 Duration: 13 weeks 40 hours per week Shift: 8 hours, days Employment Type: Travel About Genie Healthcare Genie Healthcare is one of the fastest growing Nurse Travel Agencies in the USA. Genie serves hundreds of facilities and has over 4000 current travel RN contracts open at any given time. Genie provides travel RN's flexibility, support, top pay scale, housing and the #1 rated, multi-state health insurance coverage. Genie Healthcare carries with it a commitment to providing a comprehensive level of service and quality care. Growing from a small team of eager recruiters to a company with satisfied clients in nearly every corner of the nation, delivering excellence in patient and customer care is the key to Genie's success. The management team has 20 years of experience in workforce solutions and staffing in medical and non-medical fields, roles ranging from Clerical job to Cardiologist to software developer to CEO.

The Manager, LMS Operations & Administration position works as part of the U.S. Ethics & Compliance Training & Documentation team to lead all components of our Learning Management System (LMS) including all non-GxP assignments and audience management, curriculum management, reporting, and tier one trouble shooting. The Manager, LMS Operations & Administration will partner with all levels of Management in both business and technology groups to advance and deliver a variety of planned and ad-hoc training initiatives. This position will have direct oversight of two Contracted Workers. **** + Responsible for the operational oversight of all LMS activities including but not limited to: + Partner with internal LMS Support Team to perform needs assessments and analysis on platform operations to ensure organizational needs are being met. Leads the incorporation, socialization, and training of resulting LMS improvements. + Owns all non-GxP LMS usage workflows and processes with business owners for suitability/fit; suggests and implements alternatives as needed + Regularly perform reviews of existing training curricula, identify gaps in course assignments and implement necessary changes. + Create, maintain, and run scheduled as well as custom reports, in a timely manner, as designated for analysis and decision making. Create new reports as requested. + Assist in managing external vendors, suppliers, and internal business partners as needed with a continuous improvement mindset. + Partner across departments as necessary to initiate timely and compliant learning initiatives + Continually enhance our methods and materials based on best practices in the industry, emerging technologies, vendor resources and products, business unit requirements and expectations, and feedback from customers, trainers and associates. + Ensure operational alignment across OAPI/OPDC learning community + Develop and deliver LMS platform training when required. + Oversee the work of two remote-based contracted resources. + Represent Field Training and Development's unique needs at governance and committee meetings/working groups **Qualifications/ Required** Knowledge/ Experience and Skills: + Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities + 5+ years of Learning Management System (LMS) experience + Advanced working knowledge of LearnShare LMS + Understanding of current approaches in applying technology in learning solutions and experience implementing e-Learning and web-based programs. + Strong technical acumen; proficiency in Microsoft Office 365, SCORM; experience with Tin Can/xAPI, LRS's, and general technical troubleshooting + Ability to work in a fast-paced environment and be comfortable with consistent change + Detail-oriented with strong organizational skills + Strong written and verbal communication skills + Ability to prioritize and manage multiple responsibilities at once + Positive can-do attitude; always willing to learn + Strong analytical/technical skills + Comfortable with data management/data manipulation + Resiliency and tolerance of ambiguity **Preferred:** + Experience in pharmaceuticals/medical devices or other regulated industry + Embody a customer service mentality as you communicate and support field sales teams + Experience leading Contract Workers remotely Educational Qualifications + Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities **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 $104,640.00 - Maximum $156,400.00, 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 Title: Medication Room-Picker Reports to: Distribution Center Manager, Distribution Center Assistant Manager, Room Lead Status: Non-Exempt This position is full-time and located at the Lewis Distribution Center in north central Sioux Falls, SD. Schedule is Monday through Friday 6:30am to 3pm. Summary The Medication Room Employee will be responsible for performing various warehouse duties within the Lewis Distribution Center (DC); more specifically, the prescription medication room. These duties will include but are not limited to: receiving and processing incoming products, picking and filling orders, packing and shipping orders, and managing and organizing products. All duties within the DC need to be completed accurately and within a timely manner. Essential Duties and Responsibilities Ability to accurately read and interpret an invoice, store transfer order, or product order to determine items that need to be counted, received or shipped Ability to move products from receiving areas to designated holding areas of the DC Unload and open boxes, pallets, crates and other containers Label products and pallets with appropriate numbers for tracking within the DC Sort and place products on racks, shelves, pallets or in totes according to factors such as shape, size, UPC, color, etc. Sort, label and properly store perishable products in refrigerated areas Accurately verify and fill store orders from stock and properly prep orders for shipping out Record item description and quantity to be received or shipped out on corresponding forms Keep all equipment and work areas in the DC clean and free of debris Ability to operate, or learn to operate, various warehouse equipment and machines Ability to communicate with all levels of employees within the company Must be able to effectively handle a heavy workload Additional duties as assigned by management Employee Role Expectations Maintain regular and punctual attendance as scheduled Learn and follow all company safety procedures and protocols Proper use of equipment and machines, at all times, to prevent injury to self and/or others Follow verbal and/or written instruction Must work with accuracy and have strong attention to detail Ability to work independently or as a team member Ability to work harmoniously with other employees within the drug room and DC Strong organizational skills and ability to multitask Qualifications High school diploma or equivalent required (or in progress) Basic math and computer skills Ability to read and write in English Knowledge of Lewis Drug processes a plus Knowledge of RF-Smart and NetSuite a plus Physical Requirements Frequently position self to lift or move objects and operate equipment within the DC Constantly lift and/or move objects up to 10 lbs., frequently up to 50 lbs., and occasionally up to 100 lbs. with or without accommodation Work with full range of hands, wrists, and arms (i.e. Ability to pick up and pinch small items with fingers, and seize, hold, grasp or turn objects with hands) Visual requirements include vision from less than 20 inches to more than 20 feet with or without correction Must have depth perception, color vision (ability to identify and distinguish colors), and field of vision Must have ability to communicate verbally with staff & coworkers Must be able to work in a setting with exposure to outdoor elements including, but not limited to, extreme temperatures and loud environments Benefits (Full-time employees) Medical, dental, and vision insurance HSA, FSA, LPFSA options Voluntary options: life, long-term disability, life/long-term care hybrid, cancer, critical illness, accident, identity theft protection Employee discount, includes prescriptions Retirement savings (401k) Paid Time Off (PTO) Paid volunteer time Company paid short term disability Company paid life insurance Discounted logowear Employee Assistance Program Benefits (Part-time employees) Employee discount, includes prescriptions Retirement savings (401k) Paid Time Off (PTO) Discounted logowear Employee Assistance Program

Job Title: Loss Prevention Officer Reports to: Loss Prevention Manager, Store Manager This position is part time and located in Sioux Falls, SD. The primary schedule will be evenings and weekends. The loss prevention officer will work as a team member to implement procedures and systems to prevent merchandise loss and maintain a safe environment. The loss prevention officer will conduct audits and investigations of employee activity. This individual may assist in developing policies, procedures and training for safeguarding assets. Essential Duties and Responsibilities Identify and report safety concerns to maintain a safe environment for employees and guests Communicate and enforce company policies and expectations for safety and loss prevention Operate a closed circuit television system for observation Observe, apprehend and process shoplifters in accordance with company guidelines Observe, document and report internal safety and theft concerns Complete building and grounds inspections for safety concerns Prepare written reports on investigations Perform other duties as assigned by manager Employee Role Expectations Honesty and integrity are required Ability to use clear judgment in stressful situations Must have strong attention to detail Ability to multitask Excellent verbal and written communication skills Excellent organizational skills Ability to operate surveillance equipment and computers Physical Requirements Must be able to remain stationary for long periods of time Must be able to constantly move or position self for observation and inspections Occasionally lift up to 50 lbs. with or without accommodation Qualifications High school diploma or equivalent required Retail experience helpful but not required Background in law enforcement or military helpful but not required

The Director, Nephrology & Immunology Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and Immunology therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, Nephrology & Immunology Medical Communications Lead and plays a key leadership role in advancing Otsuka's mission to deliver impactful, evidence-based science that improves patient outcomes. **** **Key Responsibilities Include:** **Publications Strategy and Execution** + Lead execution of the publication plans for Nephrology and Immunology assets, ensuring strategic alignment with global medical objectives, data dissemination priorities, and the product lifecycle + Partner with Medical Communications and cross-functional teams to define publication timelines, data priorities, and congress/journal strategies in collaboration with study teams and medical leaders + Oversee the end-to-end development of publication deliverables, including abstracts, posters, and manuscripts to ensure scientific accuracy, quality, and adherence to Good Publication Practices (GPP), ICMJE, and company SOPs + Support the integration of publication insights into broader scientific communication platforms (SCPs), ensuring consistency across core content, field materials, and other medical channels **Vendor & Budget Management** + Manage publication vendors and medical writing partners to ensure timely delivery, cost-effectiveness + Oversee operational management of external publication agencies, providing clear direction, review, and feedback to ensure alignment with scientific and compliance standards + Manage assigned publication budgets, including forecasting, tracking, and reconciliation + Ensure efficient resource utilization and drive continuous process improvement across publication workflows **Cross-functional Leadership** + Collaborate closely with Clinical Development, Global Integrated Evidence & Innovation, Medical Strategy, and Core Content teams to ensure data readiness, accurate interpretation, and timely publication of key clinical results + Serve as a publications subject matter expert within the Nephrology & Immunology Medical Communications function, providing strategic and operational guidance to internal stakeholders and vendors + Partner with Field Medical and Medical Information to ensure consistency of published data messaging across medical channels and external communications + Contribute to integrated medical communication planning, ensuring that publications effectively support data dissemination goals and launch readiness activities + Consider technology and AI to support workflow improvement **Compliance & Quality Oversight** + Ensure all publication activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/global regulatory requirements + Partner with Legal, Regulatory, and Compliance teams to uphold publication governance, authorship transparency, and ethical data sharing standards + Contribute to audit readiness and documentation best practices for publication records and approvals **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs, Medical Communications, or Publications within the pharmaceutical or biotechnology industry + Minimum 3-5 years of experience leading publication planning and execution for global or regional programs, preferably in Nephrology, Immunology, or related therapeutic areas + Proven experience managing vendors and external medical writers, including budget oversight and performance evaluation + Strong understanding of Good Publication Practices (GPP), ICMJE guidelines, and industry standards for scientific and medical communication **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Demonstrated ability to lead publication strategy execution across global and regional teams + Exceptional project management and organizational skills, with the ability to manage multiple concurrent publication deliverables + Excellent written and verbal communication skills, with meticulous attention to scientific accuracy and compliance + Strong cross-functional collaboration skills, with the ability to influence and align internal and external partners + Proven leadership in vendor management, process optimization, and publication operations + Financial acumen and experience managing publication budgets + Strategic thinker with operational excellence mindset and the ability to translate complex data into clear, evidence-based scientific narratives **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 $205,368.00 - Maximum $307,050.00, 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.

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. **Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine** Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Job Title:** Data Management Lead (Medical Affairs) - Oncology **About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you! **Who You Are:** **Required:** + BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience. + 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data) + Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology + Strong project management experience + Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required). + Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity. + Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing. + Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques. + Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment. + Ownership and accountability relative to key accountabilities in the job description. + Ability to travel as required. + Written and oral fluency in English. **Preferred:** + Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI). + Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau). + Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming. + BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions. **What you will be doing:** **Responsibilities will include:** + Develop risk management strategies and proactively manage timel What ines to ensure successful oversight and delivery of studies and projects. + Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones. + Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models. + Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data. + Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results. + Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis. **Cross-functional Data Management Leadership:** + Manage and coordinate the integration and utilization of all ancillary systems. + Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan. + Review and analyze metrics to derive meaningful summaries of study health and trends. + Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators. + Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs. **Project Financial and Resource Management:** + Ensure appropriate project-level resourcing of staff and staff assignments. + Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand. + Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope. **Company Initiatives:** + Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole. + Support other functions by providing meaningful feedback on initiatives. + Ensure Parexel-requested information entered into management systems is accurate and regularly updated. **Training:** + Maintain training compliance as per job roles assigned, including on-the-job training. + Deliver project-specific training to internal Data Management teams. + Address training needs based on identified development goals. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job Description Mental Health Therapist Employment Category: Full-time Employment Type: Salaried / Exempt Reports To: Clinical Director Supplemental compensation for crisis on-call work Benefits: health, dental, and life insurance coverage; 401K participation; paid holidays; paid YMCA family membership; vacation and medical leave Perquisites: opportunity for licensure supervision; ability to pursue on-going training, specialization and/or certification; flexible work schedule; supportive team environment that promotes staff wellness and self-care *CACS is a National Health Service Corps (NHSC) and South Dakota State Loan Repayment Program approved site which can provide opportunities for student loan reimbursement. *Please review the application requirements at the end of the document. _____________________________________________________________________________________________________________________________ Position Description Provide evidence-based therapy as part of a collaborative team. Opportunities to serve individuals, groups, and families. Client population served dependent on agency need with consideration for therapist preference and expertise. Duties / Responsibilities: Complete comprehensive mental health assessments. Develop, implement, and regularly review treatment plans. Complete progress notes and other necessary documentation within Electronic Health Record (EHR) according to agency, state, and federal guidelines. Coordinate client care with other professionals and community partners. Demonstrate competency in utilizing the DSM-5-TR, or its successor, to diagnose psychiatric disorders. Apply evidenced-based therapeutic interventions according to clients' individual needs. Utilize culturally responsive approaches in working with diverse populations. Respond to crisis situations compassionately and appropriately. Deliver services in outpatient office setting or wherever necessary to meet clients' needs. Participate in Mobile Crisis Response (MCR) on-call team and complete risk assessments with individuals who are in crisis (additional compensation provided). Pursue continuing education with opportunity to specialize based on personal interest and agency need. Participate in regular clinical supervision. Attend meetings and trainings as assigned. Perform other job-related duties as assigned. Required Skills / Abilities: Adhere to HIPAA guidelines and agency policies. Be self-directive while also seeking clinical supervision when appropriate. Maintain calendars and manage workload effectively. Demonstrate effective communication and organizational skills. Establish and maintain effective working relationships with clients and colleagues. Proficient in computer applications and related technology. Meet deadlines. Follow all local, state, and federal laws. Adhere to professional codes of ethics and agency policies and procedures. May need to use personal vehicle for work-related tasks and provide proof of insurance. Work hours may include some evening and weekend hours. Must have a valid driver's license. Education and Experience: Master's degree in counseling, social work, or psychology and licensed in the State of South Dakota or working toward licensure (supervision for licensure provided on site). When eligible, complete training for and obtain Qualified Mental Health Professional (QMHP) certification. Physical Requirements: Requires periods of moving throughout the office and may require traveling to other locations within the community (i.e. jail, schools, community partner agencies) and designated coverage area. Requires periods sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. **REQUIREMENT FOR ALL APPLICANTS: Please include a cover letter and resume for this position. If you are unable to upload a document please enter your cover letter content in the Objective / Summary section, and your resume information in the Resume section. Please include the following in your cover letter: 1. Why you are interested in this position. 2. How your past work experience/education has prepared you for this position. **NOTICE TO APPLICANTS REGARDING WAGE RANGES: The wage or salary range listed in this job posting reflects the full compensation range established for the position. Our agency follows a structured compensation strategy to ensure fair and competitive offers aligned with each candidate's individual qualifications. The final starting wage for a selected candidate is based on a comprehensive evaluation of the following factors: Relevant years of experience Education beyond the minimum qualifications Relevant professional licenses or certifications Please note that the upper end of the salary range reflects the compensation of the most tenured and highly experienced employees in this role, based on market data within the industry. It is not intended to represent the typical starting wage for new hires. We appreciate your interest in joining our team and look forward to reviewing your application. #hc202615

The Associate Director, Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and tactical implementation for congresses and medical education, and supporting Otsuka's non-promotional scientific communication initiatives across the diverse Rare Disease portfolio. This role leads scientific engagement through impactful congress planning & execution educational programs, and evidence-based content that support Otsuka's mission to improve patient outcomes through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional cross-functional stakeholders - including Global Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I) and Commercial, to ensure scientific alignment, operational excellence and consistency in Otsuka's external scientific exchange. **** **Key Responsibilities Include:** **Congress Strategy and Execution** + Manage execution and contribute to the development of comprehensive multi-year medical congress strategy for the relevant therapeutic area aligned with Otsuka's pipeline and product lifecycle stages (e.g., establishing and developing an emerging portfolio), including prioritization of key international and regional congresses, scientific communication objectives, symposia, booth presence, and internal/external engagement activities + Collaborate with Medical Strategy, Medical Communications, Field Medical and Medical Information to develop high-quality, scientifically rigorous presentation and materials; ensuring data dissemination plans are timely, consistent, and strategically aligned + Support scientific communication planning across global and regional teams to ensure consistent, data-driven communication objectives across congress activities + Partner with Medical Communications to coordinate Otsuka's scientific presence at congresses, including: + Abstract submissions and poster presentations + Oral presentations and late-breaking sessions + Sponsored symposia and educational sessions + Medical booth design and operations + Press activities and medical engagement + Support planning and execution of engagement with external experts and stakeholders (e.g. KOLs, Patient Advocacy Groups) before during and after congresses + Organize and facilitate investigator meetings and advisory boards in conjunction with congress + Coordinate opportunities for scientific exchange between Otsuka Medical Affairs personnel and external experts and stakeholders + Manage end-to-end aspects of congress planning activities and post-congress insight generation to maximize impact and inform future strategies + Implement innovative digital strategies to extend congress reach and engagement, including virtual and hybrid congress solutions + Establish KPIs for congress activities and implement systems to track and analyze performance + Conduct post-congress analysis toa assess impact and identify areas for improvement **Independent Medical Education (IME)** + Develop and implement the global medical education strategy for relevant therapeutic area in alignment with medical and objectives and strategy + Oversee the development of scientific exchange platforms, independent medical education (IME) initiatives to elevate disease and product knowledge globally + Partner with regional and local teams to ensure educational programs address unmet needs and comply with regional regulations and global standards + Identify, evaluate, and partner with external experts, medical societies and educational providers to ensure high-quality, unbiased scientific content delivery + Monitor educational impact through KPIs, metrics and insights **Cross-Functional Collaboration** + Act as a key contributor and subject matter expert for the relevant therapeutic area medical education and congress activities + Collaborate with Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Regulatory, and Commercial teams to ensure scientific alignment and appropriate integration of new evidence into educational content + Provide guidance and mentorship to team members and vendors to ensure high standards of scientific integrity, external experts and stakeholder (e.g., KOL) experience and operational excellence + Create and manage congress budgets, ensuring cost-effectiveness and ROI and ensure compliant use of medical education and congress funding + Represent Global Medical Affairs in governance forums and cross-functional planning meetings + Ensure all congress and medical education activities comply with global and local regulatory requirements, Otsuka policies, data publication embargos and industry codes + Proactively identify and mitigate risks related to scientific exchange and external engagements based on Global Medical Affairs policies and SOPs + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) preferred + Extensive experience working within relevant therapeutic area, including engagement with specialized HCPs and evidence generation strategies + Additional business or communications training (MBA, MPH, etc.) preferred + 12+ years of experience in Medical Affairs; ~5 years focused on congress strategy and execution is preferred + Proven success managing matrixed & cross-functional global teams and external vendors + Demonstrated experience leading global congress strategy, IME programs, or scientific engagement + Proven track record of successful congress planning and implementation on a global scale including implementation of digital and virtual congress solutions + In-depth understanding of industry compliance, regulatory frameworks, and ethical considerations for scientific engagement **Skills and Competencies:** + Strategic and analytical thinker with the ability to translate complex science for a variety of audiences and anticipate trends and shape proactive congress and educational strategies + Excellent project management, communication (written and verbal), and stakeholder engagement skills + Collaborative and communicative, with ability excel at building and maintaining relationships with external stakeholders and experts (e.g. KOLs, scientific) + Financial acumen and experience managing large program budget + Ability to influence across matrixed teams and drive strategic initiatives **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 $169,222.00 - Maximum $253,000.00, 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.

At **Parexel** , we don't just support drug development-we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding biopharma companies through complex regulatory landscapes to bring safer, more effective therapies to patients worldwide. You will: - Lead strategic regulatory initiatives across diverse product types and global markets - Advise clients throughout the product lifecycle, from early development to post-marketing - Share your scientific, technical, and commercial expertise to influence regulatory outcomes - Collaborate with and lead teams of respected subject matter experts - Represent Parexel as a visible thought leader in the industry - Meet new situations and learn all the time. In fact, one of the key characteristics you'll see in our Sr/VP Techs is innate curiosity along with a passion for the science, the industry, and public health. **If you're committed to public health and want to make a difference, this is the ideal role.** We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A Senior/Vice President Technical must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Senior/Vice President Technical must have a thorough understanding of the organization's consulting models and methodologies, as well as extensive knowledge of what services RS provides. A Senior/Vice President Technical provides a full range of consulting services and works within their personal area of expertise. A Senior/Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS. A Senior/Vice President Technical participates in the development of new service offerings, consulting models and methodologies. Project Execution + Works within a team environment or individually based on project needs + Works within broad project guidelines and leads issue and conflict resolution + Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives + Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action + Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met + Manages project engagements (small or large) + Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support + Provides guidance to project team members and acts as a mentor to junior staff Thought Leadership + Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field + Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums + Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met + Regularly quoted by general and industry news outlets + When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations + Contributes expertise to professional societies, academic or other similar groups influential in his/her area of expertise + Reinforces the knowledge-centered activities within RS based on their own knowledge and expertise + Facilitates improvements to Parexel business processes + Facilitates new service and consulting model development Consulting Activities and Relationship Management + Adapts the appropriate organization's consulting models and methodologies when unique situations present themselves as well as designs/improves the methodologies when needed + Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies + Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction + Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined + Acts as a loaned executive for a client when required + Facilitates resolutions to possible problems or conflicts within the project team and/or the client + Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities + Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client's business and key industry drivers + Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite + Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and build relationships which results in additional business or referrals + Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management Requirements + Education - MD required + Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and expertise in reviewing and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related medical role is required. _Depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical_ + Extensive Endocrinology, Neuroscience, Rare Disease, or Immunology experience is required. + The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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.

Join Parexel's team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. **Job Title:** Market Development Analyst At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients. We are seeking a Market Development Analyst to join our team. As a Market Development Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences for patients by connecting new clients with Parexel's capabilities. Through the collaboration, and diversity, of teams the Market Data Analyst is provided with multiple opportunities to excel and discover where your skills can take you. **Who we're looking for:** + Excellent communicator to effectively present information and respond to questions from groups of managers, clients, customers, and other business units + Analytical mind to read and interpret general business periodicals, professional journals, and technical procedures + Strong interpersonal skills with the ability to establish and maintain effective working relationships + Quick learner who excels in a rapidly changing environment + Practical problem solver + Minimum 2 years' experience in B2B lead generation or sales role **What you'll do:** + Work strategically with Marketing and Sales Teams to generate marketing campaigns for all lines of the Parexel business including promoting webinars, customer days and other marketing-driven events. + Analyze potential opportunities and develop strategies to support increasing client awareness and engagement; monitor actions and results against plans + Schedule introductory business development calls between sales team members and target company decision-makers. + Work closely with Sales Associates and Account Executives to ensure smooth transfer of information and accounts. + Collaborate with Director of Market Development, senior Sales staff, and Subject Matter Experts to develop market strategies to generate leads with new clients; re-engage past clients, and within current core accounts across all Parexel service lines. + Respond to Parexel web leads / inbound requests as first point of contact to conduct needs assessment + Track all activity with prospects and clients in Parexel's CRM system + Other responsibilities as assigned **Additional details:** + Prior CRO, life sciences, or consulting company experience preferred but not required **Why join us:** + Be part of groundbreaking projects that are pushing the boundaries of the industry. + Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. + Enjoy work life balance and flexible working hours. **Parexel US Benefits:** + Health, Vision & Dental Insurance + Tuition Reimbursement + Vacation/Holiday/Sick Time + Flexible Spending & Health Savings Accounts + Work/Life Balance + 401(k) with Company match + Pet Insurance + Full list of benefits available here: *********************************** If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department. OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka's global health-care products. The Global Clinical Development Program Leader is responsible for leading the end-to-end strategy, and development and delivery of a portfolio of novel serotonergic agonists (NSA). Shaping and executing late-stage clinical development strategies for the NSA portfolio of therapeutic assets, ensuring programs progress efficiently toward registration and commercialization. This role serves as the primary and single point of contact for internal and external stakeholders, ensuring seamless integration, governance, and lifecycle management from early-stage development through submission to global health authorities. This role provides scientific, clinical, and strategic leadership across Phase II/III program design, evidence-generation plans, regulatory interactions, and cross-functional integration to support differentiated therapeutic value and patient outcomes. In addition to overseeing clinical development, the leader will play a central role in creating a unique, patient-centered go-to-market strategy tailored to the emerging psychedelic medicines landscape. This includes orchestrating health economics and outcomes research, defining care-delivery models, navigating reimbursement and market access pathways, and partnering with commercial, medical affairs, and external stakeholders to build scalable, ethically grounded treatment ecosystems. **** The specific duties assigned to the Executive Director; Global Clinical Development Program Lead will include the following: **Key Role Accountabilities:** Summary of Global Clinical Development Program Lead for the NSA Portfolio include: + Establish & continually evolve global portfolio strategy indications/sequencing. Align with Product Development Committee (PDC) and the Early Development Team (EDT) based on internal strategy and competitive landscape + Recommend individual asset strategies that supports a differentiated product profile including proposed go/no-go criteria (early to late phase) + Broader portfolio evidence generation strategy + Align COA endpoint development and validation work across individual assets + Drive portfolio-wide stakeholder strategy through external landscape & policy shaping (GA, PASM, GMA, GRA, Corporate Comms) and identify synergies with the broader CNS portfolio + Drive internal and external communication strategy + Develop and continually evolve differentiated global go-to-market strategy based on unique attributes of assets within the portfolio: + Reimbursement and coding coverage + Broader portfolio global commercialization assessment/planning to drive asset's global CDP + Patient support/wrap around services + Provide overall portfolio asset prioritization and support for discovery programs and indication selection + Set overarching regulatory strategy and endorse individual asset strategies as needed + Endorse proposed go/no-go criteria and support PDC for action points and EDTs for governance engagement for portfolio assets + Endorse CDPs for discovery/early stage and late-stage programs + Portfolio KOL engagement & patient advocacy strategy **Strategy & Execution** + Serve as the primary point of contact for key partners, ensuring collaborative and productive relationships. + Drives the asset's initial indication development strategy, including scientific, regulatory, and clinical access. + Drives asset/brand vision and strategy through all lifecycle development activities, including registrational studies, as well as post-marketing studies + Shapes products for competitive profile that achieves pricing, reimbursement, access and penetration by developing target product profile, developing initial indication label in-line with target profile, and creating economic value dossier + Oversees and adheres to the governance processes for the selected asset and drives the achievement of key milestones + Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other team members, and to external regulatory agencies. + Constantly seeks innovative ways to grow the value of the asset throughout the product lifecycle by leveraging the team's experience and skillset. + Co-leads regulatory filing activities through NDA. Provides strategic direction to ensure concise, clear and convincing argumentation in all written and verbal communications. + Recommends Business Development activities necessary for optimization of the portfolio value i.e., provide development perspective during due diligence or recommend opportunities that can help further support the specific portfolio group of assets **Leadership & Matrix Management** + Sets vision for the Product Development Team and ensures the matrix team remains aligned and engaged toward that vision + Oversees relevant sub-teams and ensures clear goals are aligned with development team short- and long-term and performance standards are in place. Provides feedback and coaching and holds sub-team leaders accountable for key deliverables + Manages performance across the matrix team, in collaboration with the functional leaders. + Demonstrates peer-to-peer influence across R&D functional leadership + Establishes trusting relationships locally and globally across the enterprise to advocate for the asset **Stakeholder Engagement & Communication** + Manages integration points and communications with key stakeholders across all Otsuka functions and market areas to ensure alignment and minimize risk + Monitor and manage contractual obligations, performance metrics, and governance structures. + Ensures appropriate decisions are made in a timely manner and effectively navigates relevant governance to keep stakeholders informed and aligned while driving outcomes + Builds and manages relationships with external stakeholders (Opinion Leaders, Patient advocacy leaders, health authorities) + Support interpretation of key clinical trial results, regulatory feedback and other relevant information and lead the integration of these new findings into the cross-functional asset strategy **Qualifications** Required + A minimum of 10 years of experience in the pharmaceutical industry, extensive working knowledge in the drug development process with proven progression in relevant R&D roles and significant experience in related therapeutic areas as well as pediatric drug development. + Experience in managing/leading high performance, cross-functional teams (Matrix) or complex organizations successfully + Understanding of regulatory policies and impact of public relations (US and Global preferred) + Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries (e.g. R&D, disease mgt., marketing, external development) and building strong external relationships + Abreast of scientific issues as they impact business development and strategic planning + Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets + Understanding of regulatory policies and impact of public relations + Demonstrated use of communication and change management strategies/tactics to influence new ways of thinking and working + Success in effectively communicating and influencing decisions with senior management + Ability to navigate through ambiguous and changing healthcare landscape + An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing. + Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings + Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies. + Willingness to travel 35% of time, over weekends and ability to travel internationally.. Preferred + MD / PhD / PharmD / secondary scientific degree preferred or commensurate experience + Medical, clinical and/or public health experience within the therapeutic area of psychiatry or neurology **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $249,973.00 - Maximum $388,125.00, 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.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Clinical Consultant / Clinical Educator for Critical Care Monitoring Devices and Clinical Applications Full-Time Traveling opportunities for candidates in California metropolitan areas. Are you a Critical Care RN who loves your healthcare career but need a change from the everyday grind of the bedside? Are you a leader who enjoys providing education to your peers? Ever wonder what it would be like to travel, explore new environments, while meeting and training new colleagues? If so, we invite you to partner with us for an opportunity as a traveling Clinical Educator! Our Clinical Solutions division offers a unique and exciting professional growth opportunity in the medical device and clinical information systems arena. We provide clinical application support for the world's top patient monitoring device company. Our full-time Educators travel to healthcare facilities to provide end-user training, configuration, and go-live support. We and our client are committed to your success! The orientation for this role is typically 6 months long and includes classroom and field training. You will learn a lot about yourself, healthcare management and operations, and an assortment of clinical practices and implementations. You can become an expert in the latest healthcare technology and develop or enhance many professional skills. We are not a recruitment agency and these positions are benefit eligible. Our full-time benefits include: paid time off, health, dental, vision, and life insurance; short and long-term disability, 401k and more. A corporate credit card is available for business travel expenses! If you have the qualifications listed below and a commitment to the requirements, all you need to bring is yourself and enthusiasm! Availability and Travel requirements: * Schedule requirements: Maintain availability (48+ weeks per year) of 4-5 days per week between Monday and Friday, plus travel. Must be available for departure travel on Sundays to return on Thursdays or Fridays; OR, departure on Mondays to return on Fridays or Saturdays. And, must be willing to work 5 days per week, 50% of the time, when assignment needs are longer than the 4 days. * Readiness and willingness to work all shifts (Days, Evenings, and Nights) without disinclination or declination. * Ability to travel for several consecutive overnights across the California State territory. * Must live within 1 hour of a major US airport for air travel needs (including willingness to fly regional jets) and have access to reliable transportation for drivable assignments 4-5 hours from home. * Currently live in a California metropolitan area Position Duties and Responsibilities: * Travels to customer sites to educate and support healthcare professionals in operating their critical care monitors proficiently and safely. * Configures or design monitor set-up per client company directed parameters and customer consultation. * Provides post-sales end-user education classes/in-services. * Delivers go-live support with new monitors or upgrades. * Upholds customer focus by proactive assessment and appropriate communication/escalation of customer needs and solutions. * Communicates with client company Clinical Specialists and completes documentation, as required. * Maintains competency on product via company provided training events (classroom training, online learning modules, etc.) * Optimizes travel strategies for cost savings. * Maintains successful completion of corporate and client training modules. * Completes expense and hourly reports as outlined. * Meets and maintains vendor credentialing requirements with immunizations and related medical requirements. * Sustains current driver's license and acceptable driving record

**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. **Position Overview:** The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence. This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used. **Key Responsibilities:** + **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency. + **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution. + **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through. + **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities. + **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI. + **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities. + **Compliance Management:** Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities. **Qualifications:** + Bachelor's degree required; MBA or advanced degree preferred. + Minimum of 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution. + Prior experience in field leadership roles such as first- or second-line leadership, regional operational and customer strategy roles or other field-based support roles required. + Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization. + Ability to focus on priorities and resolve operational issues effectively. + Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency. **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 $194,247.00 - Maximum $290,375.00, 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.

Drug Utilization Review Pharmacist - Ensure Safe and Effective Use of Medications A confidential managed care organization is seeking a skilled Drug Utilization Review (DUR) Pharmacist to support quality prescribing and improve patient outcomes. This role is ideal for pharmacists who enjoy analyzing medication use, applying clinical guidelines, and collaborating with providers to promote safe, cost-effective care. Key Responsibilities Conduct prospective, concurrent, and retrospective drug utilization reviews. Evaluate prescribing patterns against clinical guidelines and formulary criteria. Identify potential drug interactions, duplications, and inappropriate therapy. Prepare recommendations for prescribers to optimize therapy and reduce risk. Document reviews and ensure compliance with state, federal, and health plan requirements. Contribute to quality improvement initiatives and pharmacy program development. What You'll Bring Education: Doctor of Pharmacy (PharmD) or Bachelor of Pharmacy degree. Licensure: Active and unrestricted pharmacist license in the U.S. Experience: Managed care, PBM, or health plan experience preferred - but hospital and retail pharmacists with strong clinical skills are encouraged to apply. Skills: Analytical mindset, detail-oriented, and excellent written and verbal communication. Why This Role? Impact: Shape prescribing decisions that affect thousands of patients. Growth: Build expertise in managed care and population health pharmacy. Flexibility: Many DUR roles offer hybrid or fully remote schedules. Rewards: Competitive salary, benefits, and career advancement opportunities. About Us We are a confidential healthcare partner providing managed care pharmacy services nationwide. Our DUR pharmacists play a key role in ensuring that medications are used safely, appropriately, and cost-effectively across diverse patient populations. Apply Today Advance your career in managed care pharmacy - apply now for our Drug Utilization Review Pharmacist opening and help lead the way in improving medication safety and outcomes.