Senior Project Manager jobs at Kelsey-Seybold Clinic - 103 jobs

**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **Brief Job Overview** This role is a non-supervisory position responsible for working with key customers and stakeholders in the excipients industry on acquisition and complete submission of information for USP documentary standards, primarily in the North America (NORAM) and Europe Regions. This role will be responsible for delivering USP monograph donations for excipients and other raw materials through effective and appropriate stakeholder engagement. The incumbent works directly with companies with raw materials or testing of raw materials that are included in FDA approved products/processes as well as with internal USP staff globally including: Program Units, Strategic Customer Development Managers, Scientific Experts, and Business Leaders. This includes management of day-to-day activities including company meetings, planning, reporting and tracking to ensure delivery of key targets and growth goals. This role requires excellent interpersonal and communication skills, with the ability to influence cross-functional teams and external stakeholders. This role is within the Regions & Program Operations Division and reports to the Donations Director. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments The **Donations Engagement Manager** has the following responsibilities: + Develops donation focused account strategies, driving ongoing collaboration and alignment across all relevant internal stakeholders/partners. + Lead monograph acquisition (donation) efforts globally, and as needed, with particular focus in NorAm and Europe at assigned companies. + Identify and develop key contacts for acquiring the information required to develop USP's public standards. This includes the development of new monographs, modernization of existing monographs, and compendial requests to address FDA comments on proposed monographs to the USP-NF. + Develops specific plans and performance targets that supports overall donations strategies. + Deliver on monograph donation targets, ensuring quality data/components for further development by Science and USP Expert Committees, in an expeditious and efficient manner + Educate, support, and assist the sponsor of a potential monograph with guidance related to USP and how USP fits into a comprehensive compendial strategy. + Regularly engages in business and relationship development activities with identified donors and other relevant stakeholders. Develops and nurtures relationships with key people and decision-makers within each account. Leverages internal USP resources to effectively position all relevant USP resources to further the mission of USP. + Regularly executes professional presentations to donors to include, but not limited to the C-suite, Regulatory Affairs, Quality and R & D departments (and their respective staff). + Develops an overall understanding of USP's business (Small Molecules, Biologics, Growth Programs) to ensure that conversations with donors can foster broader collaborative dialogue between USP and targeted donors. + Understands the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect USP and external accounts. + Has ability to provide scientific and technical support to assigned donors. Leverage internal USP counterpart resources such as Science, SCD, Scientific Affairs and USP Education, for inquires and/or programs that need greater detail and program content expertise. + Maintains and updates account information for all assigned accounts. Updates contact management system with all relevant donor information. Uses information strategically to be proactive at engaging USP resources. Makes the requisite number of touch points (phone calls, emails, teleconferences, meetings, and customer visits) to assigned donor accounts to the responsible individuals and decision-makers on USP's standards development process, and opportunities for donor contributions, with a primary focus on monographs, and documenting calls, meetings and emails in Salesforce. + Supports donor events and workshops to enhance and promote the importance stakeholder contributions to the standards development process. Identifying contacts at assigned companies to work with USP on new monographs, monograph improvement and bulk material. Develop and report on understanding drivers and barriers for donations. + Keep track of the progress to goals, monthly. Help to increase our understanding of the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect our Mission. + Works as part of a Team leveraging the resources in donations operations and donor recognition to support our donors and elevate the impact our donors provide for global public health. Travel can be up to 50%, both domestic and international. Perform other related duties as assigned. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + Bachelor's degree in chemistry, or a related science field, required or a business degree or related field. + Seven (7) years' experience in a life sciences role, preferably in the pharmaceutical, specialty chemical industry or contract laboratory services that does testing for the pharmaceutical industry or other evidence of experience in conducting USP-NF testing in an analytical laboratory. + Three (3) years of experience providing account management to pharmaceutical or chemical/laboratory supply channels. + Experience in life sciences related work with demonstrated customer facing engagement activities including but not limited to face-to-face interactions and digital touchpoints. + Good interpersonal skills, communication skills, and telephone manner required. + Advanced understanding of pharmacopeia and use of compendial standards + Advanced understanding of the pharmaceutical industry + The ability to influence without direct authority. + Results-driven with demonstrated successful outcomes. + Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner. + Ability to handle multiple priorities in a fast-paced environment. + Able to work flexible hours when needed, including travel between 40-60% of the time. **Additional Desired Preferences** + Experience using data analytical platform (e.g. Tableau) and CRM platform (e.g. Sales Force) a plus. + Previous donation/stakeholder engagement (including sales) experience a plus. + Experience with regulatory compliance, quality control, quality assurance or GMP background a plus. + Account management skills required. + Strong problem-solving skills with customer-centric approach. + Excellent relationship-building skills with stakeholders. + Excellent in person & virtual presentation skills. + Self-motivated and able to work in a fast-paced multi-task environment. + Combined education in Pharma science and business is highly preferred. + Proficiency with Microsoft Office, data query, analysis, and reporting. + Superior interpersonal skills: professionalism, collaboration, accountability, delegation, and customer service + Ability to build effective work relationships quickly and work collaboratively in a global setting both internally and externally. + Ability to effectively manage multiple competing priorities with high attention to detail. + Knowledge of USP products and services is highly preferred. + High business acumen abilities - can understand and deliver on business objectives. + High comfort with navigating through ambiguity and frequent change, and course-adjusting in the moment. + Demonstrated initiative and resourcefulness with good judgement. + Strong influence, negotiation, critical thinking, problem-solving and conflict resolution skills. **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Salary Range: USD $98,900.00 - $127,250.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Technical Programs **Job Type** Full-Time

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: Serve as primary point-of-contact and primary escalation point to the client Coordinate and oversees all functional services including external vendors to the established timeline and budget Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation Establish tracking metrics to monitor trial and team progress towards project goals Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise Leads both internal and client meetings and set expectations for the project team Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required Perform other duties as assigned by management Remain compliant with organisational training, time-reporting and any other administrative duties as required Provides on-going feedback, for functional team members including annual performance reviews Qualifications: Minimum Required: North America: Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience Experience in managing complex and global trials Ability to travel domestically and internationally including overnight stays Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS Proven communication and interpersonal skills to effectively interface with others in a team setting Proven organizational skills, attention to detail, and a customer service demeanour Competencies: Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items Proven knowledge of project management techniques aPay transparencynd tools Direct work experience in a global, cross-functional project management environment Good understanding of cross-functional management Good understanding of project planning, risk management and change management with an awareness of appropriate escalation Proven experience in strategic planning, risk management and change management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective Ability to lead and inspire excellence within a study team Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Proven presentation, verbal and written communications skills Good understanding of project management software In depth proven experience in pharmaceutical and/or device research required Preferred: experience with oncology & cell and/or gene therapy #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$147,300-$220,900 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Do you enjoy working in a fast-paced environment where you are empowered to make strategic decisions and contribute to a growing and profitable company? Join us at Medpace! Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Global Study Start-Up Project Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace. Incentives can include: Competitive bonus program, sign-on bonus, and equity awards. Location: Remote Responsibilities * Efficiently manage successful execution of global start-up, maintenance, and close-out studies; * Effectively lead others in a matrix environment; * Perform quality checks on submission documents and site essential documents; * Prepare and approve informed consent forms; * Serve as a Sponsor point of contact for start-up and regulatory submissions items; * Review pertinent regulations to develop proactive solutions to start-up challenges; * Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits; * Contribute to the growth and development of departmental staff, processes and systems. Qualifications * Bachelor's degree required, advanced degree in Life Sciences preferred * 5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up * Project management experience and demonstrated role in developing others * Strong oral and written communication skills required Travel: Minimal Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks * Flexible work environment * Competitive PTO packages - starting at 20+ days * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Competitive compensation and benefits package * Structured career paths with opportunities for professional growth * Discounts for local businesses Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Project Management department does at Worldwide Worldwide Clinical Trials Project management is the perfect blend of operational rigor and therapeutic expertise, with a client-focused approach. Our Global Project Leads (GPLs) and Clinical Project Managers (CPMs) expertly guide our project teams to deliver with high quality, focusing on “doing it right the first time”. The Project Management team is engaged in all aspects of the trial collaborating with scientific and therapeutic leadership, coordinating across project teams, and providing flexible, innovative and proactive solutions. At Worldwide, you will be dedicated to a specific therapeutic area which will not only give you an opportunity to develop in depth global operational expertise, but also benefit from exceptional scientific and medical background that our experts bring. What you will do Senior Project Manager (SPM) is responsible for the overall coordination and management of clinical trials from start-up through closeout activities. Directs the technical, financial and operational aspects of the projects -- thus securing the successful completion of clinical trials. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented. Works to ensure that all project deliverables meet the customer's time/quality/cost expectations. The SPM, with support from the Project Management Directors, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet the customer/contract expectations. What you will bring to the role High level of responsibility and accountability in all tasks. Communication skills. Ability to effectively perform in demanding situations. Thorough knowledge of project management processes with a solid understanding of how to craft and manage a project budget. Can demonstrate experience of successfully managing and/or leading multidisciplinary project teams. Proficiency in computer skills, including familiarity with relevant software and application (MS Office). Your experience 6-7 years' industry experience with a minimum of 5 years in a Clinical Project Management role, within a CRO setting. University/College degree, within Life Science is preferred. Experience managing Oncology studies is required for this role. Ability to travel when needed. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

At PRECISION AQ, the Senior Program Manager (SPM) is a member of the team leadership. The SPM is responsible for creating, managing and communicating the program development workflow plan and providing the Scientific Director (SD) and Strategic Account Director or Manager (SAD/SAM) with the timing and process information required for them to effectively and efficiently manage their departments, programs and the client. Essential Functions: Program Planning: Under the supervision of the Program Director, create, manage and communicate the development workflow plan to ensure all members are aware of current status, next steps, potential roadblocks and solutions at all times. Organize and maintain the online project folders per SOP guidelines and work closely with the Program Manager and Coordinator to ensure all client communications and financial documents are archived properly. Oversee the client's medical/legal/regulatory (MLR) process with the PM Team including submissions, liaison with internal MLR team, communications with the client's MLR coordinator and monitoring status. May represent the Program Management department during pitches and assist with new business activity. Team Management: Manage and mentor Program Manager and Coordinator; partner with support teams for resource needs, oversee all internal and external meetings to provide objectives and clear actionable items post-meetings; train and onboard new PM team members Finance: Participate in the statement of work (SOW) development in a consultative role with the SAD in detailing scope and allocating team members hours. Work closely with the team to ensure they are alerting the SAD of scope changes and time-of-staff overages. Monitor the BVA reports with the Financial Analyst and alert the SAD of any deviations from the contract. Oversee the invoicing process including reconciliation and client financial reports. Client Management: Act as primary client contact for project status, MLR process, and invoicing Communication: Provide strong verbal and written communications to the client and internal teams including status reports and meetings, financial reports, assignment reports and meeting agendas and summaries Compliance: Ensure compliance guidelines are followed including but not limited to legal templates, Sunshine Act reporting, and client training requirements Program Logistics: Depending on account requirements, manage and oversee logistics vendor and perform meeting planning tasks, including site search, venue contracting, travel arrangements, food/beverage and audio-visual equipment for live events Vendor and Agency Partner Management: Manage vendors not associated with strategy and content such as print, video production, transcription. Work closely with team leadership to manage other vendors in collaboration with or under the direction of the SAD or SD Staff Management: Manage and train assigned Program Coordinators and/or Program Managers Competencies: Capable of managing many complex projects with multiple staff members and tight deadlines Experience in a variety of medical communication promotional project types with ability to quickly learn new ones Being proactive and taking a leadership role when required Understanding the development process and identifying potential problems Anticipating and providing solutions to potential problems and unexpected challenges MS Office programs including MS Project and search engines Verbal and written communications Interpersonal skills Managing many project details with strong organization skills Financial requirements for a service-based business including budget development, monitoring and management Managing staff including performance reviews, action plans, training and mentoring Qualifications Bachelor's Degree 5-7 years of project management experience in a pharmaceutical-related service-based business such as medical communications, advertising, sales training or digital production MS Office programs including MS Project and search engines This position requires travel Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$79,108.80-$118,663.20 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Title: CMC Global Project Manager Company: Ipsen Pharma (SAS) Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at ********************** and follow our latest news on LinkedIn and Instagram. Job Description: WHAT - Summary & Purpose of the Position All Ipsen's assets are managed through a fully integrated Asset Team focused on maximizing patient value and the success of the asset in all aspects across its entire lifecycle. The main mission of the CMC Global Project Manager (GPM) is to work in collaboration with the CMC Lead, the Asset Operations Lead (AOL), and the Asset Team (AT) to develop, implement and manage strategic CMC roadmap by driving the cross functional CMC Subteam. The CMC GPM closely partners with the CMC Lead to serve as the central points of contact for the CMC Subteam members and when necessary, serves as deputy for CMC Lead. A CMC GPM may support multiples assets. The secondary mission of the CMC GPM is to support transversal projects/initiatives within GPO, with the aim of improving operational efficiencies across Asset Operations, CMC and GPO teams' scope of responsibilities. The CMC Global Project Manager is responsible for the creation, maintenance and execution of the operational CMC plans to enable the successful CMC delivery of the project. They ensure that all steps of the CMC project plan are anticipated, planned, coordinated and followed up to deliver in the most efficient process. They are responsible for providing guidance, instruction, and leadership skills to develop optimal CMC roadmap on each asset and to inspire the team to perform at their optimum. They monitor and track its associated budgets (internal and external costs) and support resource management against agreed strategic objectives for the program. There are responsible for ensuring consistent communication between project CMC functions and for ensuring key issues are escalated to management in due time and with a mitigation plan. The CMC GPM also ensures that a consistent project risk management methodology is applied at the Asset Team and CMC Subteam level to proactively identify project risks and opportunities together with contingencies and to use learning and experience from current, previous projects, competitor benchmarking and from the network of Global Project Managers to support successful delivery (knowledge management). A CMC Subteam is defined as a cross functional team accountable for concrete deliverables such as IMP and IND/NDA or could be all activities related to the development of the asset in one indication / population (clinical development, CMC, regulatory, industrial and commercial). WHAT - Main Responsibilities & Technical Competencies Project Operational Leadership * Serve as the central operational point of contact for CMC, project subteams and Asset Team members * Work in partnership with the CMC Lead, Functions reps to create and maintain asset CMC roadmap from overall asset strategy * Create a climate that fosters personal investment and excellence and nurtures commitment to common goals * Facilitate the process for evaluation of alternative development options at the CMC and project levels to deliver programs * Facilitate win/win solutions for program/team conflicts with big picture in mind. Promote ideas persuasively and build on the ideas of others Project Management * Create and maintain CMC Project Plan across functional lines, capturing interdependencies between all functions and deliverables, to be updated at least once a month, highlighting critical path and upcoming deliverables, and aligned with the Global Asset Plan * Partner with CMC Lead and functional reps to 'pressure-test' assumptions and integrate function planning to support the CMC project plans * Create and maintain the asset CMC Assumptions slide as a key input to the project plan, scenario planning, risk analysis and budget * Define the interdependent CMC subteam deliverables aligned with Global Asset Plan and ensure that quality, risk, cost, time are managed to drive delivery of asset roadmap milestones and objectives on time and on budget * Validate the technical integrity of the CMC project plans ensuring that the technical data is reviewed and discussed at the CMC subteam meeting for appropriate decision making/recommendation to the Asset Team on follow-up actions * Update full-scale CMC project plans, timelines, budgets and milestones regularly in the appropriate tool to ensure data for metrics reporting is accurate * Drives with the CMC Lead milestone decision point planning, execution of CMC plan and associated deliverables across functions to achieve the overall asset objectives. * Implement and drive cross-functional monthly CMC operational meeting to closely and proactively monitor the execution of plans, measures result, update and align key planning assumptions with corresponding timing, risks, resources, and budget impacts and communicate deviations/discrepancies to AOL, specifically focusing on: * Deliverables on time / at risk * Key milestones * Budget / Resource * Contingencies * Resource constraints if required. * Issues and correct deviation to ensure successful project delivery * Clearly define the critical path and generate clear decision criteria for the project * Ensure decisions and actions are tracked in due time * Perform oversight of all activities and associated deliverables under the accountability of the CMC subteams * Demonstrate an appropriate level of technical understanding of the various functions to ensure effective cross-functional communication * Responsible for ensuring that all the projects CMC functions deliver with precise execution, quality, on time and within budgets * Proactively manage changes in project scope, anticipating potential problems (potential resource bottlenecks, risks to critical milestones, inefficient processes, and resource variance) and proactively develops and seeks approval for risk mitigation plans * Responsible for supporting functional leads in vendor selection and management as required * Comply with all laws, regulations and policies that govern the conduct of IPSEN activities. Always follow IPSEN policies, procedures and processes (including Global R&D Operation ones, such as governance process) * Actively adhere to a Quality Management System (QMS) that supports GxPs and Regulatory requirements and satisfy all internal quality and external regulatory authority expectations * Ensure project / workstream deliverables are managed to enable completion on time and according to required scope and budget, while applying the best practices and tools of an efficient PMO * Ensure project / workstream deliverables are managed to enable completion on time and according to required scope and budget, while applying the best practices and tools of an efficient PMO Risk Management * Apply a consistent and comprehensive risk management methodology that proactively identifies CMC risks and opportunities together with developing and delivering appropriate contingencies and/or corrective actions to support the team in development of solutions to project conflicts and issues * Apply a deep understanding of risk management methodology in using risk to communicate effectively with Governance bodies and underpin project strategy and delivery. Budget and Resource Management * Partner with the CMC Lead and function representatives in the CMC subteam to ensure that budget, resource management and project controls are established. * Manage CMC project budget and resource plan in partnership with the AOL, CMC Lead, Finance lead, function heads and function representatives in the team * Support AOL to lead budget sessions at intervals that align with Finance budget/forecast calendar delivering and to translate board decisions to team and project budgets * Ensure actuals are properly recorded and coded to the project * Ensure all supportive materials and data are provided for tax credit requests on due time * Support CMC Lead to ensure resource, cost and schedule are up to date to enable long term planning Knowledge Management * Perform "lessons learned" workshops to identify CMC project learnings to be applied across the portfolio on an as-needed basis (at minimum at stage / gate) * Develop a mindset around benchmarking versus competitors and use this approach to challenge plans and decisions with the team Communication and Reporting * Effectively communicate project expectations to CMC subteam members, senior leaders and the broader organization. Escalate issues to team members and stakeholders in a timely fashion. * Define governance strategy, streamline governance process and decision making at the Asset level, create and communicate governance material with all involved stakeholders and the PFM team. * Prepare and manage governance interactions in partnership with the CMC Lead and AOL * Define and implement a communication strategy / plan for the project that supports the most effective team empowerment and progress. * Define and report metrics to measure project performance, while executing the plan CMC Global Project Manager (GPM) Competency Matrix: CMC Global Project Manager Stakeholder Management Engages with CMC teams and internal stakeholders to ensure smooth execution of project activities. Supports cross-functional collaboration and ensures alignment across functions but has limited influence on senior leadership. Regulatory & Compliance Knowledge Intermediate knowledge of regulatory frameworks, submission processes, and compliance risks. Drug Development Expertise (by Stage) Intermediate knowledge across all phases. Depends on functional leads for deep scientific execution. Ability to ensure overall CMC plan alignment with development plans and anticipate activities interdependencies Risk & Issue Management Proactively assesses risks across multiple activities. Develops contingency plans and mitigates potential delays or budget overruns. Escalates major issues to AT and senior management Budget & Cost Control Manages CMC project budgets, monitors costs, and controls expenses within the approved financial framework. Works with finance/functional representatives to have them develop the budget numbers (external costs & resource) forecasts Communication & Negotiation Communicates with CMC subteams and CMC Lead. Presents project updates internally but has limited exposure to senior leadership. Ensures effective cross-functional communication to resolve conflicts and drives project success. Cross-Functional Team Leadership Supports and coordinates CMC teams, ensuring alignment across multiple function representatives (regulatory, manufacturing, formulation, analytics, quality and supply). Drives collaboration across functions reps in the CMC Subteam. Ensures clear task ownership and follows up on execution. Technology & Data Management Intermediate use of corporate project management tools to build and maintain plan, track progress, milestones, and risks. Prepares dashboards to assess project performance and support strategic decisions. Change Management & Process Improvement Implements process improvements to increase efficiency. Drives continuous improvement within project teams. Leadership & Mentorship Supports CMC project teams, ensuring coordination and task completion. Supports team collaboration but has limited mentorship responsibilities. Provides guidance on project execution and risk management. Develops leadership skills within the project management team. KPI & Performance Tracking Tracks project milestones, timelines, and quality metrics. Reports on deviations and corrective actions. Ensures multiple activities meet KPIs and are executed efficiently. Strategic Thinking & Innovation Ability to prioritize activities based on asset/business needs. Identifies and integrates process improvements to enhance efficiency. Proactively introduces new project management methodologies. Planning Develops and maintains integrated CMC project plan and execution roadmaps. Ensures alignment with global timelines. Supports scenario planning at CMC subteam level. Data, Data Management & Analytics Collects and organizes project-related data using standard tracking tools. Reporting Prepares regular CMC project status reports for internal teams and stakeholders. Ensures data accuracy and timely submission. HOW - Behavioural Competencies Required HOW - Knowledge & Experience Knowledge & Experience (essential): * This a role that requires full understanding of drug development business processes * 5-10 years' experience in the Pharmaceutical / Biotech industry with experience working within the CMC development of manufacturing, pharmaceutical formulations across different modalities. Understanding of the drug development process, clinical development, and project management. Knowledge in early phase development, late phase, phase III, filing and launch phases would be considered beneficial. * Demonstrated experience in leading operations (i.e. project management) in cross-functional drug development teams * Agility, proactivity, & leadership skills and emotional intelligence to lead with influence * Ability to work collaboratively in a cross functional environment * Demonstrated ability to effectively prioritize, multitask and execute tasks in a fast-paced environment * Problem solving & decision-making skills. Demonstrated ability to drive initiatives, solve issues (conflict management and facilitation skills), anticipate problems and achieve objectives, while keeping an eye on the big picture. * Excellent communication and interpersonal skills. Networking and stakeholder management skills. Ability to establish and maintain effective working relationships with R&D departments, Franchise, Industrial, Medical Affairs and external customers/contractors. * Financial acumen to develop/manage project budgets * Strong experience in facilitating/driving project team meetings, cross-functional communication, decision making and ensuring alignment with internal/external stakeholders * Work constructively under pressure. Good clarity of judgment and effectiveness at implementation of solutions * Highly competent in use of Microsoft Office, Microsoft Project and other PM appropriate tools * Strong customer and patient focus Knowledge & Experience (preferred): * US / EU pharmaceutical regulations experience * Experience working within 1-2 functional areas such as CMC, clinical, preclinical or regulatory affairs Education / Certifications (essential): * Bachelor's Degree in Science Education / Certifications (preferred): * Certification in Project Management. PhD or PharmD is a plus. Language(s) (essential): * English / French Language(s) (preferred): * English / French #LI-MM1 #LI-hybrid #LI-MM1 #LI-hybrid Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons " The Real Us*". La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforcons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SMI is one of the most highly regarded technology producers in the human services field. We develop state-of-the-art solutions for complex human service operations. To maintain our prominence in this competitive industry, SMI recruits individuals who are technical, creative, client-focused, and most importantly willing to go the Extra Mile. With over 50 years as a family-owned and operated business, SMI considers its employees and clients part of an extended family. We are a family serving families. Our culture is one of teamwork, dedication, empowerment, and a strong emphasis on work-life balance. We offer an optimal atmosphere for career growth and achievement while remaining competitive in terms of compensation and benefits. We are a multi-state operation and administrative private company with a staff of over 650 employees throughout the United States. We depend on the expertise of our SMI team to support and develop the very best systems and product lines in the industry and expect continued innovation. If you are looking for a meaningful and fulfilling career, we hope that you will consider SMI. Job Summary: As a Project Analyst at SMI, you will play a pivotal role in the successful execution of projects related to payment processing and fintech solutions. You will leverage your expertise in project management and your knowledge of payment processing and/or fintech solutions to ensure projects are completed on time, within scope, and to the highest quality standards. The role will report to the Vice President of Project Management. Key Functions/ Basic Duties: Project Planning and Execution: Help lead projects and initiatives, managing business requirements, timing, risks, issues, decisions, interdependencies, and milestones. Develop comprehensive project plans, defining scope, objectives, deliverables, and timelines. Lead cross-functional teams to execute projects efficiently and effectively. Payment Processing and Fintech Expertise: Leverage your knowledge of payment processing and/or fintech solutions to provide insights, guidance, and solutions to project challenges. Ensure compliance with industry standards and regulations. Resource Management: Manage project resources effectively, including team members, budgets, and technology resources, to meet project goals. Risk Management: Identify project risks and develop mitigation strategies. Proactively address issues that may impact project success. Stakeholder Communication: Maintain clear and regular communication with stakeholders, including clients, team members, and executives, to provide project updates and ensure alignment with business objectives. Project Documentation: Create and maintain detailed project documentation, including project plans, status reports, and documentation related to payment processing and fintech requirements. Quality Assurance: Ensure project deliverables meet quality standards and adhere to best practices in payment processing and fintech. Project Management Tools: Proficiently use project management tools such as Microsoft Project and Smartsheet to track and manage project progress, tasks, and dependencies. Team Leadership: Mentor and coach team members, fostering a collaborative and high-performance work environment. Education and/ or Experience: Bachelor's degree in a related field (Business, Finance, Computer Science, etc.) Minimum of 3 years of experience in project management, specifically in payment processing and/or fintech. Proven track record of successfully managing complex projects from initiation to completion. Proficiency in project management software, including Smartsheet and Microsoft Project. Strong understanding of payment processing systems, fintech solutions, and relevant industry regulations. Excellent communication, leadership, and problem-solving skills. PMP or other relevant project management certification. Language Skills: Speaks English fluently. Computer Skills: Proficient in MS Office Suite and Smartsheet. We are an Equal Opportunity Employer. We are a Drug-Free Workplace.

▶About This Opportunity General Description This position is part of the Enterprise PMO responsible to provide project and program management for key strategic and operational initiatives at 7-Eleven involving cross functional teams and budgets up to $10MM+. The project manager is responsible to develop and execute PMO projects to ensure cross functional alignment, drive and manage the teams to meet strict deadlines and achieve financial goals. Responsibilities include financial and project governance, project execution excellence and reducing risks for SEI leveraging project management principles and tools. Duties and Responsibilities include but are not limited to: • Ensures that program scope and business objectives are clearly documented and agreed to for complex, cross-functional projects. • Identify and organize the appropriate cross-functional teams to achieve project goals. Collaborate with cross-functional teams to develop detailed project plans, identifying the proper work streams owners and cross-work stream dependencies. Coach teams to ensure the project team works together efficiently and effectively. • Work collaboratively with business owners to define initial budget and resources required. Manage and analyze on-going financials to ensure project is tracking to budget. • Understand the details of the project plan to effectively manage the dependencies and adjust plans as necessary. Drive accountability and project progress according to the aligned-on project plan. • Identify and document project risks and issues, escalating when appropriate and developing mitigation strategies to minimize project impacts. • Through regular cadence of reporting, ensure visibility and transparency on project progress milestones, financial governance, issues and risks. • Focus on driving results, finding cost saving opportunities and efficiencies in the project life cycle while leveraging project best practices. • Ability to effectively facilitate and lead meetings of varying size and purpose In addition to the skills above, the Project Manager needs to be proficient and demonstrate the following leadership competencies: • Ability to effectively build relationships to influence stakeholders and teams through indirect leadership, working across organizational lines and varying levels of the organization, including VP/SVP level. • Demonstrated ability to communicate key project points and adjust communications as needed based on audience, making the complex simple to understand. • Develop an understanding of company vision, strategy, and key initiatives. Achieve detailed understanding of functional area of the project and related processes to be able to challenge assumptions and thinking and provide thought leadership. • Ability to solve problems by assessing the situation, leveraging data where applicable, identifying root cause and developing potential solutions. • Ability to operate in environments with ambiguity and ability create clarity. • High level of agility and adaptability; ability to quickly learn details of new business functions and operate in various project methodologies • Identify dependencies and impacts of project changes across other key initiatives • Contribute to continuous improvement of PMO processes and maturity • Manage collaboration and communication with other teams, both internal and external, to ensure teams have what they need and can work efficiently. Knowledge, Skills and Abilities • Education: Bachelors/4-Yr Degree, MBA/Master's preferred • Experience: 5-10 years' experience leading teams and/or projects, setting strategic direction and execution plans, Program Management and project governance. • Familiarity with project governance and PMP ideologies. PMP not required but preferred. • Strong analytical skills and process improvement viewpoint. • Strong Word/Excel/PowerPoint skills mandatory. • Excellent verbal & written communication skills required. • Effectively interact & influence internal & external stakeholders at all levels. If an hourly or salary range is included in this ad it represents the range 7-Eleven in good faith believes is the range of compensation for this role at the time of this posting. The Company may ultimately pay more or less than the posted range. This range is only applicable for jobs to be performed in this state. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, long-term incentive compensation, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. For a general description of all benefits 7-Eleven is offering in the US for the position, please visit this link .

We are seeking a Steel Project Manager for a direct hire, long-term opportunity in Fresno, CA. Overview: Overseeing structural steel projects from fabrication to erection. Projects: Commercial retail and public works Pay: $120-150K, plus a generous yearly discretionary bonus Schedule: Mon-Friday (8 am to 5 pm) Benefits: Vehicle allowance or company-provided vehicle, 401K match at 4%, medical, dental, and vision benefits and more! Travel: Only to the projects in California. Travel to remote job sites may be required; occasional overnight stays depending on project location Relocation: Relocation assistance is available for the ideal candidate Key Responsibilities for Steel Project Manager: Contract Review & Interpretation - Review and interpret contract documents, plans, and specifications. Scheduling - Develop and align project schedules with structural steel fabrication and erection sequences. Relationship Management - Build and maintain relationships with superintendents, managers, erectors, and vendors. Submittals & Documentation - Facilitate, review, and submit project submittals, RFIs, change orders, and invoices. Shop Drawings - Create and review hand shop drawings when required. Field Coordination - Conduct field measurements as needed; develop site-specific erection procedures and plans. Procurement & Job Buyout - Oversee buyouts and coordinate fabrication, delivery, and installation with shop and field personnel. Cost Control - Monitor project budgets, track job costs, and provide timely reports. Software Integration - Utilize Tekla EPM and Procore to manage workflow, costs, and communication. Meetings- Attend job kick-off meetings. Qualifications for Steel Project Manager: 5+ years of relevant experience, with a strong background in structural steel project management. Office experience in the field of Architecture, Engineering, or Construction Preferred Ability to operate common office software programs, including Microsoft Office products (e.g., Word, Excel, Outlook), Adobe Acrobat, Procore, and Construction Partner. Knowledge of office management systems and procedures Excellent time management skills and ability to multitask and prioritize work If you are interested in learning more about this role, please submit your resume for immediate consideration!

Job DescriptionWe are seeking a Steel Project Manager for a direct hire, long-term opportunity in Fresno, CA. Overview: Overseeing structural steel projects from fabrication to erection. Projects: Commercial retail and public works Pay: $120-150K, plus a generous yearly discretionary bonus Schedule: Mon-Friday (8 am to 5 pm) Benefits: Vehicle allowance or company-provided vehicle, 401K match at 4%, medical, dental, and vision benefits and more! Travel: Only to the projects in California. Travel to remote job sites may be required; occasional overnight stays depending on project location Relocation: Relocation assistance is available for the ideal candidate Key Responsibilities for Steel Project Manager: Contract Review & Interpretation - Review and interpret contract documents, plans, and specifications. Scheduling - Develop and align project schedules with structural steel fabrication and erection sequences. Relationship Management - Build and maintain relationships with superintendents, managers, erectors, and vendors. Submittals & Documentation - Facilitate, review, and submit project submittals, RFIs, change orders, and invoices. Shop Drawings - Create and review hand shop drawings when required. Field Coordination - Conduct field measurements as needed; develop site-specific erection procedures and plans. Procurement & Job Buyout - Oversee buyouts and coordinate fabrication, delivery, and installation with shop and field personnel. Cost Control - Monitor project budgets, track job costs, and provide timely reports. Software Integration - Utilize Tekla EPM and Procore to manage workflow, costs, and communication. Meetings- Attend job kick-off meetings. Qualifications for Steel Project Manager: 5+ years of relevant experience, with a strong background in structural steel project management. Office experience in the field of Architecture, Engineering, or Construction Preferred Ability to operate common office software programs, including Microsoft Office products (e.g., Word, Excel, Outlook), Adobe Acrobat, Procore, and Construction Partner. Knowledge of office management systems and procedures Excellent time management skills and ability to multitask and prioritize work If you are interested in learning more about this role, please submit your resume for immediate consideration! Powered by JazzHR klx CmIlY44

The Field Force Effectiveness team at Otsuka America Pharmaceutical, Inc. plays a highly visible role in optimizing the performance of the sales and marketing efforts, for the field sales teams. As a result, Systems Training plays a key role in ensuring that the sales force understands how to effectively utilize our technology to enhance customer interactions, optimize selling opportunities and provide insight on our business processes that support our business. The Senior Manager of National Systems Training work with the field sales teams to design, develop and deliver new hire systems tech training on our InGenius (CRM System), ORION (Field Reporting) and Business Planning system across all brands. The role is also responsible or continual training on system enhancements and capabilities for the organization. In addition, the role will require system training content updates and cross collaboration between systems owners and multiple departments such as compliance, operations, IT, sales leadership, and marketing partners. The Senior Manager of National Systems Training will report to the Director, of Marketing and Sales Technologies and partner closely Training & Development & Home Office functions. In addition, the role will work with our internal Field Force Effectiveness points to identify user experience improvements and capabilities that better support a seamless customer interaction in the field. **Core Responsibilities:** + New Hire system training CRM, Field Reporting and Business Planning across all commercial sales teams + Responsible for developing and updating training materials and curriculum to reflect system enhancements + Provide ongoing training on system enhancements to support the field sales teams + Coordinate with Field Training and Development teams on New Hire Training content and agenda + Identify key user experience insights and ongoing system training opportunities collected from field ride observations + Incorporate business processes education in training sessions to support Otsuka's ways of working + Work closely with the Field Force Effectiveness team to identify user experience improvements + Partner with system owners to design training content to support enhancements and new capabilities + Develop pull through strategies to support ongoing system and business process learnings for the field. Such as Specialty Attestation, Customer Affiliations, Precall and Post Call Planning, Field Reporting Insights etc. + Work closely with cross-functional teams and stakeholders to define training needs and requirements **Qualifications:** Required + Bachelor's degree: MBA or other related graduate degree preferred + Ability to communicate technical information in a way that is easy to understand for the field and effectively identify key selling opportunities + Strong command of CRM, Field Reporting and Business Planning systems and the ability to train on them + Previous experience in a Region or Ecosystem point role that supports training and coaching field team members + Ability to work in an ambiguous environment undergoing transformation + Excellent communication, collaboration, facilitation, and presentation skills + Possess a growth mindset that is open to development & coaching and willing to challenge the statue quo + Proven track record for consistently meeting or exceeding performance goals + Understands and articulates healthcare compliance, legal and regulatory landscape + Technical acumen and understanding the backend systems + Experience selecting and managing training vendors + Abilify to create content in PowerPoint or other tools Preferred + Previous experience in a field leadership or coaching role that supports business acumen development of the sales team members + Experience as a training in the pharmaceutical industry + Understanding of principles of instructional design and adult learning theory + Experience with putting material through the Promotional, Regulatory and Compliance Review Process **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 $150,034.00 - Maximum $224,250.00, 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.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). Strong project management skills with a track record of managing complex projects and meeting deadlines. Excellent organizational and communication skills. Excellent time management abilities Proficient in Microsoft Office Suite Proven experience with project management software ie. Smartsheet Strong communication and interpersonal skills Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones #LI-LB1 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.

Why PRECISIONeffect? When you love what you do, it won't feel like work. Who says your calling and career have to be mutually exclusive? People who join us at PRECISIONeffect are drawn to our agency because of their passion for and commitment to truly cutting-edge and incredible work - they stay for our ethos of wecentricity, the community and collaboration we foster here. Launching clients' treatments. Changing patients' lives. Advancing creativity and strategy, improving results and outcomes. We do our best and most innovative work when it's fueled by purpose and comprised of the unique and varied perspectives and abilities of Effectors across the globe. At PRECISIONeffect, talent is displayed in the work, not flaunted in plumes of conceit. Here, cooperation and wecentricity are what we champion. Are you a self-effacing rock star? A sensible diva? A down-to-earth maestro? Have we got a stage for you. Our people are wildly talented, clever, and inspiring. Who we are: The Project Management team is the engine that keeps the agency machine running. We are strategic problem solvers and communicators that lead cross-functional teams from planning to project delivery. PM's are the barometer for teams, and collaborate with all departments to ensure work is executed on time and on budget, and partner with Account Teams in strategic planning and workflow. We radiate wecentricity and a constructive approach to all work, with a focus on efficiency and effectiveness. Who you are: Project Managers are a problem solvers who bring a skilled team together to ensure the agency successfully executes and delivers to market, within the agreed time and budget. Essential functions of the job include but are not limited to: Project Planning Reporting to and partnering with the Group Project Manager and/or Sr. Project Managers to: Review high-level client, program/campaign and project plan for the year Obtain a clear understanding of client expectations and rules of engagement Develop actionable project plans and vet through key team members Coordinate and collaborate with account leads in developing a plan for new or shifting tactics Review and provide input to project brief, budget, and schedule prior to kickoff Meeting Management Prepare for and lead all internal meetings Provide goals and objectives, pre-meeting Open all meetings with attendees/roles, goals/objectives of the meeting, and materials provided for the meeting Close all meetings with summary of discussion, decisions made, and immediate next steps Facilitate meetings to ensure meeting stays on track and on time Responsible for weekly status of the accounts they work on Workflow/Process Understand and advocate for the workflow process and each team member's role and responsibility within the workflow Review action orders (AOs) to ensure clear and executable direction is provided Lead the online routing of projects, while ensuring quality assurance at each step Maintain WF for all projects responsible for Communications Provide constant communication via teams, workfront, email, phont etc to meet client expectations and deliverables Client expectations and deliverables Resource allocation requirements Advocate for the team while monitoring delivery dates and budget burn Provide alternative solutions to ensure project stays on track Lead teams in clear, constructive, solutions oriented communications Growth/Advancement Opportunities Statement of work (SOW) review and input Research process and industry practices Identify and share best practices Qualifications: Minimum Required: Bachelor's Degree 2 years' direct work experience in a project management capacity, including all aspects of project planning through execution and delivery Other Required: Proficient in MS Office, including MS Project and/or an online project management workflow tool Experienced in digital, print and broadcast production May require travel domestically and/or internationally including overnight stays Preferred: Agency experience preferred. Pharmaceutical exposure desired Competencies: Proactive and effective communicator with multiple team members in varying departments Analytical in thinking (assumptions and risk evaluation) Flexible and agile Collaborative Thorough and efficient in time management Detail Oriented #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$60,000-$90,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: Understands various cost models and develops budgets for moderate complexity projects. Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management. Develops moderate complexity project timelines independently. Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. Participates in or leads bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 years' experience in project coordination or project management or similar field required. Expert knowledge of scientific principles and concepts. Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Powered by JazzHR Vb1hE8LBAc

Candidate will be responsible for Multiple Automation Engineering Projects : Manage design, installation, and quality testing aspects of automation projects in a GMP facility. Understand and manage the Lifecycle of automation projects Manage the materials planning, budget development, and cost control Manage a detailed project schedule and work plan Contribute to identifying and addressing complex technical issues Interface with vendors, when necessary, to ensure vendors deliver parts, materials, components, equipment, and services on -time, on -budget, and to technical specifications Requirements Good technical understanding of the automation space. Need technical knowledge of IT/automation (i.e. server upgrades, DeltaV, PLC ) and technical knowledge in the automation space is also necessary, but that's just to be effective as a PM. A successful candidate for this position should possess technical knowledge including, but not limited to: data exchange, supervisory control (including SCADA systems and HMI's), historians, programming and configuration (specifically in control logic), distributed control systems (DeltaV) and integration with enterprise systems.

Delta Electronics is a global innovator at the forefront of technologies powering the future. Since 1971, we've been leading the way in high-efficiency power and thermal management solutions. Today, we're driving transformation across industries with smart, sustainable systems that enable everything from AI, industrial automation, and data centers to EV charging, renewable energy, and intelligent buildings. Key Responsibilities * Maintain clear and consistent communication with customers to ensure information is accurately shared and understood. * Assess the viability of Engineering Change Notices (ECN) and oversee their successful implementation. * Execute and uphold the corporate project system to ensure alignment with organizational standards. * Foster and maintain high levels of customer satisfaction throughout the project lifecycle. * Execute assigned projects in accordance with the established project plan and timeline. * Prepare, organize, and manage all relevant documentation throughout the project. * Complete and follow up on action items discussed during project meetings to ensure progress. * Manage routine operations and tasks related to the project to maintain efficiency and effectiveness. Minimum Qualifications * Excellent communication skills to ensure clear and accurate information exchange with customers and stakeholders. * Strong analytical and problem-solving abilities for assessing the viability and implementation of Engineering Change Notices (ECN). * Proficiency in managing and maintaining corporate project systems to align with organizational standards. * Customer-focused mindset with the ability to build and maintain high levels of satisfaction. * Strong project management skills to execute tasks according to the project plan and timelines. * Detail-oriented with the capability to prepare, organize, and manage project documentation effectively. * Ability to prioritize and complete action items from project meetings promptly. * Proficient in handling routine project operations with efficiency and attention to detail. * Bachelor's Degree in a relevant field such as Project Management, Business Administration, Engineering, or a related discipline. * Advanced knowledge or certifications in project management, such as PMP (Project Management Professional) or PRINCE2 Certification, is highly desirable. Benefit at Delta Electronics Americas Life at Delta EEO Statement Delta Electronics Americas is an Equal Opportunity Employer and is committed to compliance with all applicable federal, state, and local laws. Delta Electronics America is committed to fostering a diverse, inclusive, and respectful workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, age, marital status, national origin, disability, veteran status, or any other protected characteristic.

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

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit ******************* or follow MMS on LinkedIn. This position requires proven Project Management experience in support of Biometric deliverables (Data management, Biostatistics, Statistical Programming services). Job Responsibilities: Understands various cost models and develops budgets for moderate complexity projects. Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management. Develops moderate complexity project timelines independently. Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations. Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends. Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account. Participates in or leads bid defenses. Proficient in Word, Outlook, PowerPoint, Excel. Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met. Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000. Requirements: Bachelor's Degree required, or relevant work experience. Minimum of 2 years' experience in project coordination or project management or similar field required. Expert knowledge of scientific principles and concepts. Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

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