Senior Manager jobs at Bristol-Myers Squibb

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary Senior Managers of Statistical Programming is an individual contributor role that provides comprehensive programming expertise to clinical project teams to lead statistical programming and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams. Senior Managers of Statistical Programming also support and lead improvement initiatives. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Senior Managers also lead and support the change management process (e.g. communication, training, stakeholder engagement). Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 7 years programming experience in industry including support of significant regulatory filings For US positions: US military experience will be considered towards industry experience Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Remote - United States - US: $145,320 - $176,099 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

table.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Job Title: CENTER MANAGER Summary: Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation. Works under general occasional guidance and general oversight of regional management. Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations. Primary Responsibilities for Role: Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals. Create appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership. Operates the center and manages employees and operations to the highest standard of ethics and integrity. Manages staff to ensure that training and quality goals are met and to implement operational changes and maximize center efficiency. Directs and manages employees. Monitor and evaluate operations. Develop action plans to maximize center efficiency and supervise the implementation of process improvements. Manages headcount to provide for efficient staffing through high and low production intervals, providing accurate and timely projections to regional management team in advance of cyclical and seasonal or situational spikes. Accountable for the direction of all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records. Provides strategic direction and planning. Other Responsibilities for Role: Acts as a mentor to assigned team, other center staff and other centers. Through Assistant Manager, oversees donor selection, plasma collection and shipment and records completion. Accountable to ensure the adequate training of production employees and demonstrate how tasks are to be performed to meet company standards. Accountable for the adequacy of inventory of all goods and supplies necessary for center operations and oversee ordering goods as needed. Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order. Accountable for freezer management, including overseeing plasma shipments and equipment failures. Required to answer all freezer alarms and deal with them appropriately. Submit timely and accurate reports on a daily/weekly basis or as requested. Develop community representation with regards to all public relations and marketing campaigns to attract and retain donors. Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP). Accountable for donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP). Directs through the management team and with Training and Quality staff to ensure that training and quality goals are met. Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation. Works with Divisional/Corporate management in the preparation of annual budget and manages facility to consistently achieve production targets and quality goals at the agreed-upon cost structure. Control center donor funds and ensure that all financial records are accurate and in order. Identifies regulatory deficiencies and in collaboration with the Center Quality Manager implements immediate corrective action. Minimize center liability through constant risk management review. Investigates all unsafe situations and complaints and institutes corrective/preventive action. Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises. Assumes Regional management oversight and mentoring duties for select facilities/projects or in ROMs absence. Performs other duties as required. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Job Requirements: Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field. Typically requires a minimum of 3 years of related work experience in clinical or general business environment. Supervisory experience preferred but not required. Prior management experience, preferably supervising a group of 20 or more employees. Experience in a medical and/or cGMP regulated environment preferred. Experience with plasma or whole blood preferred. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master's degree with 2 years of experience. Attributes: Command of leadership, management, presentation, organizational, customer service, interpersonal communication, and computer skills. Ability to understand, assess and communicate FDA regulations. Ability to balance multiple competing priorities, ensure proper staffing levels, maintain adequate levels of plasma collection, and adhere to quality standards. Ability to control costs and maintain a budget. Ability to motivate staff to achieve established goals and standards. Ability to develop positive relationships with donors, center employees, and company employees working in different geographical locations. Developing command of and proficiency in at least one functional area, such as finance, IT, HR, or compliance. Ability to relocate preferred. Compensation and Benefits: This position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! “We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.” #BiomatUSA #Indeed #app #LI-Onsite #LI-BA1 #LI-RL1 Third Party Agency and Recruiter Notice: Agencies that present a candidate MUST have an active, nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Location: NORTH AMERICA : USA : CA-Moreno Valley Center Address: 718 22nd Ave South, Brookings, SD 57006 Contact: Alex S. Contreras, Senior Talent Acquisition Partner - ************** | ********************** Learn more about Grifols Follow us on Facebook: ******************************************* Follow us on LinkedIn: ***************************************** To find more jobs with Grifols: ******************** Or Text GRIFOLS to ************

Reports to: Director of Planning & Analysis Shop Avara is seeking a strategic and hands on-leader as our Director of Marketing and Customer Analytics to lead data-driven insights that fuel growth of our brand. This role will be the go-to partner for the Marketing and E-commerce teams - helping the organization deeply understand customer behavior, campaign performance, attribution, and lifetime value. You will blend analytical rigor with business understanding, turning complex data into actionable findings that can allow the marketing team to optimize acquisition, retention, and engagement. The ideal candidate thrives in a fast paced, entrepreneurial environment and is passionate about using data to unlock profitable customer growth and brand potential. Key Responsibilities Customer & Audience Insights Lead deep understanding of who our current customer is - their motivations, preferences, purchase drivers, and behavioral patterns. Own customer segmentation and profiling to identify high-value audiences and behavioral patterns. Analyze customer acquisition, retention, repeat purchase, and churn dynamics across channels. Build and maintain dashboards tracking customer KPIs (LTV, CAC, retention rate, frequency, AOV). Partner with the Marketing and E-commerce teams to inform targeting, personalization, and lifecycle strategies. Marketing Performance Analysis Lead measurement and reporting of marketing campaign performance across paid, owned, and earned channels. Build and refine marketing attribution models to assess ROI and inform budget allocation. Identify drivers of traffic, conversion, and engagement to optimize channel strategy and creative direction. E-commerce & Digital Analytics Collaborate with the E-commerce team to monitor site performance, conversion funnel, and customer journey metrics. Conduct deep-dive analyses on site behavior to identify conversion opportunities and UX improvements. Partner on A/B testing strategy and post-campaign performance evaluations. Data Infrastructure & Tooling Work with Data Engineering partners to ensure data pipelines, tagging, and integrations are optimized for marketing measurement. Define data requirements and metrics for new marketing channels, campaigns, and customer programs. Implement and manage analytics tools and visualization platforms (e.g., GA4, Looker, Amplitude, or similar). Cross-Functional Partnership Work closely with FP&A to align marketing performance insights with financial outcomes (CAC, payback, contribution margin). Collaborate cross functionally on insights that inform product development and brand storytelling. Present findings and strategic recommendations to cross functional partners and leadership in a clear, compelling, and actionable way.

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager to join our talented team at our office located in Somerset, New Jersey. In this role, you will manage project coordination with Inside Plant (“IP”) Construction and Outage Planning, the engagement of various internal departments in the project, and communicate directly to ensure that project support needs are met by internal departments. You will also manage Project Engineering in the development of the Material Tracking Log (“MTL”), support all material procurement activities, and ensure that the MTL is maintained throughout the Project lifecycle. Additional Responsibilities Organizes weekly engineering meetings between Project Management, Project Engineering, Project Controls, Procurement, Licensing and Permitting, Corporate Properties, and the Architectural Engineering (“A&E”) firms. Ensures the creation and distribution of weekly action item lists to project stakeholders. Coordinates daily communication between the Project management team, Project Engineering, and the A&E firms. Creation and management of the Project Scope Document, and participation in the procurement of all stakeholder signatures. Creation and management of the Project Execution Plan and Risk Register, and participation in the stakeholder approval process. Review Contractor submittals, including monthly reports, schedules, and cash flow documents. Manage the following: facilitation of design reviews by the Project Engineering Division, and ensuring that everything is signed by the appropriate parties the development of monthly reports for the project and engaging all stakeholders in contributing to their individual sections the facilitation of project detailed design by the A&E firm, and support the preparation, development, and review of technical specifications the execution of the Quality Assurance and Control Plan Project closeout activities, including lessons learned meetings, the submittal of As-Built drawings, documentation turnover, and the closeout of all permits and purchase orders. Support site construction management in verifying that construction activities comply with design and specifications, and support the execution of the detailed commissioning and testing plan. Support the documentation of all lessons learned activities in the Company database. The salary range for this role is between $120,000 and $150,000 but actual salary offered is dependent on experience, skill set and education. Qualifications & Requirements 15+ years of professional experience. Bachelor's degree in a technical field: engineering, project management, construction management. Professional credentialing is strongly encouraged (CCT or CCP, CST or CSP, EVP, CMIT or CCM, EIT). PMP Certification. High level of computer expertise in multiple industry-wide software products, such as: MS Office Products Scheduling software such as Primavera and MS Project Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems Context, Environment, & Safety A safety-minded individual who complies with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

Clinical Project Manager - Rare Disease San Diego, CA - On- Site $115,000 - $140,000 A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research, regulatory coordination, and cross-functional leadership. Key Responsibilities Clinical Trial Oversight: Lead the planning, execution, and closeout of global clinical studies, ensuring alignment with development and regulatory goals. Protocol & Site Management: Contribute to protocol design, site selection, and ongoing site relationships. Regulatory Support: Assist in the preparation of regulatory documents (e.g., INDs, briefing books, investigator brochures) and support health authority interactions. Cross-Functional Collaboration: Partner with internal teams across clinical operations, data management, medical affairs, and external vendors. Scientific Contribution: Review clinical data, support interpretation of results, and contribute to publications and presentations. Process Optimization: Participate in internal process improvement initiatives and mentor junior team members. Budget & Vendor Management: Develop and manage clinical trial budgets and oversee CROs and other external partners. Qualifications Advanced degree in life sciences (PharmD, PhD or MS required). 5-7 years of clinical experience in biotech or pharmaceutical settings. Proven track record in IND submissions and regulatory interactions. Experience in rare diseases, metabolic, CNS, or liver/kidney indications preferred. Familiarity with RNA-based platforms (si RNA, ASO) is a plus. Strong project management, communication, and leadership skills. Ability to work across time zones and manage international teams This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.

Job Title: Project Manager - Life Sciences Employment Type: Full-Time About the Role: We are seeking an experienced Project Manager to lead and deliver complex projects within the life sciences sector. This role requires strong technical expertise and hands-on experience with DeltaV and OSIsoft PI systems, ensuring successful implementation and integration across manufacturing and automation environments. Key Responsibilities Manage end-to-end project lifecycle for automation and process control initiatives in life sciences. Coordinate cross-functional teams including engineering, validation, and operations. Develop and maintain project plans, timelines, budgets, and resource allocation. Ensure compliance with regulatory standards (GMP, FDA, etc.). Oversee implementation and optimization of DeltaV distributed control systems. Manage data integration and analytics using OSIsoft PI for process monitoring and reporting. Identify risks, develop mitigation strategies, and ensure timely project delivery. Communicate project status and updates to stakeholders and leadership. Required Qualifications Bachelor's degree in Engineering, Life Sciences, or related field. 5+ years of project management experience in life sciences or pharmaceutical manufacturing. Proven experience with DeltaV automation systems and OSIsoft PI data historian. Strong understanding of process control, automation, and data analytics. Excellent leadership, communication, and stakeholder management skills. Familiarity with GMP and regulatory compliance requirements. Preferred Qualifications PMP or equivalent project management certification. Experience with large-scale automation projects in biotech or pharmaceutical environments. Knowledge of validation processes and documentation standards. Why Join Us? Work on cutting-edge projects in a world-class life sciences hub. Collaborative team environment with opportunities for growth. Competitive compensation and benefits package.

Primus Pharmaceuticals is looking for a highly organized and proactive Brand Project Manager to bring our campaigns, initiatives, and creative projects to life. If you thrive on keeping people aligned, deadlines met, and projects running smoothly, we'd love to meet you! Primus is an innovative company with novel products based on unmet needs that empowers providers and patients with prescription brands that maintain the highest level of safety without compromising efficacy. We are scaling proven brands into their next chapter, and the ideal candidate will find this motivating and have the leadership and skills to drive results. Position Overview The Brand Project Manager will oversee planning, coordination, and execution of marketing projects from concept to completion. This role ensures projects stay on track, deliverables meet expectations, and all work aligns with broader marketing and business goals. This position reports to the Marketing Manager. Roles & Responsibilities Manage the lifecycle of marketing projects, from kickoff through execution, delivery, and post-project review Analyze data and trends to help guide marketing direction, strengthen sales efforts, and support project planning. Partner with marketing, creative, product, and external vendors to define scope, timelines, and deliverables Develop project plans, workflows, and schedules to track progress Ensure projects remain on deadline and within budget Identify risks, roadblocks, and resource needs, proactively offering solutions Support campaign planning, content development, event coordination, digital launches, and other marketing initiative Maintain clear communication with stakeholders, providing updates and gathering feedback Improve project processes, efficiency, and transparency within the marketing function Ensure all final assets meet brand guidelines and quality standards. Manage omni-channel execution across email, web, social, paid search, leave-behinds, and detail aids. Qualifications 3+ years of experience managing marketing, creative, or cross-functional projects in pharma, bio-tech, medical devices or consumer health. Strong organizational, problem-solving, communication and time-management skills Versatile capabilities in analyzing and reporting data Ability to manage multiple deadlines and priorities in a fast-paced environment Familiarity with digital marketing, content workflows, and campaign execution Bachelor's degree in Marketing, Communications, Business, Project management, or related field (Master's degree is a plus) About Primus Pharmaceuticals, Inc. Primus innovates in prescription nutritional therapies targeting metabolic causes of chronic diseases across rheumatology, dermatology, and women's health. We develop and commercialize first-in-class products and novel deliveries in Rx drugs, medical foods, and medical devices to fill key unmet needs with universal patient access not provided by traditional pharma. Visit our website at *****************

The Project Manager Operations is responsible for managing projects as assigned, including leading and coordinating, having the ability to work independently or with minimal supervision within one or multiple departments and locations, and completing projects related to strategic, financial, and market development activities and initiatives. Ensures projects are completed on time and within scope and budget by defining and managing project goals, scope, timeline, and resources and mitigating risks and issues throughout the project lifecycle. S/he is responsible for project communication and managing numerous internal and external stakeholders, including vendors. S/he regularly provides and disseminates project analysis, assignments, timelines, and progress reports to various levels of leadership, as appropriate. Salary Range: $85,076 - $105,094 (Pay is based on several factors including but not limited to education, work experience, certifications, etc.) Qualifications: EducationA.Bachelor's degree or equivalent experience (equivalent experience includes 4 years in a project management-related role in addition to the below experience requirements. PreferredMBA, MHA, MPH, or related advanced degree Experience Minimum 3 years experience in project management roles with at minimum 1 years experience directly managing/leading highly complex projects involving multiple teams OR current KSC Administrative Fellow experience (Fellowship program must be completed to qualify for the role) OR Minimum 5 years experience in project management roles with at minimum 3 years experience directly managing/leading projects involving multiple teams - Demonstrated track record of delivering projects with significant positive financial impact - Experience in healthcare data analytics License - PMP Certification Preferred. Special Skills Strong working knowledge of healthcare/clinical operations - Ability to conduct effective presentations - Strong understanding of project management tools, methodologies, project metrics and KPIs. Experience supporting project assessments, root cause analysis, and deep dives on problem projects to get them back on track. Demonstrated a history of excellent facilitation and influence skills, working with internal and external stakeholders at all levels. Experience working with complex projects where deadlines and scope shift frequently; demonstrated ability to be flexible and adaptable to change - Advanced spreadsheet skills (i.e. creating pivot tables, performing v-lookups, and managing large data sets) Demonstrated ability to organize large-scale cross-functional projects and teams effectively - Maintains a safe environment where everyone feels respected, empowered, and free to express their constructive thoughts and feelings - Fosters an environment of creativity and innovation, focusing on the empowerment and support of staff through tools and continuous process improvement. Able to influence results without direct authority in a matrixed environment with internal and external stakeholders, including vendors.- Excellent communication (verbal and written) and critical thinking skills - Exceptional organizational and planning skills with attention to detail - Strong business acumen and technical acumen. Proficient in MS Office Suite including Project, Excel, Visio, PowerPoint, and SharePoint. Ability to successfully manage multiple priorities with competing priorities. Ability to effectively communicate with patients, physicians, family members, and co-workers in a manner consistent with a customer service focus and application of positive language principles.

NOT A C2C OPPORTUNITY 35 HOURS A WEEK Travel Requirement: 25% travel to various locations in North America for internal collaboration or onsite for project execution. During large scale projects, the percentage could fluctuate. Adherence to corporate travel and entertainment policy is required. Mobility Client Project Manager (PNA) #1044678 Job Description: We emphasize continuous learning through project reviews, which helps team members build leadership skills and operational expertise. While this role starts as a contract position, it's part of a growing team with opportunities for long-term engagement and advancement as we expand our PM capabilities. If you're looking for a role where you can make a measurable difference and grow professionally, this is the right place. Basic Qualifications - Scope: Reports to Senior Project Manager, Mobility Manages project budgets, resources, and cross-functional teams Education & Experience: University degree in business or related field preferred 5 years or more of direct experience in Project Management, Program Management, or similar experience Project Management Professional (PMP) or Certified associate in project management (CAPM) or a related PMI Certification preferred Competencies: Strategic Agility: Adapts project strategies to evolving client and business needs, balancing structure with flexibility. Communication & Influence: Communicates effectively across all levels, translating complex information into actionable insights. Process Discipline: Applies structured methodologies and tools for consistency and continuous improvement. Cross-Functional Collaboration: Builds strong partnerships across departments and with clients. Analytical Thinking: Uses data-driven insights for decision-making and risk assessment. Change Leadership: Guides teams through transformation initiatives, promoting innovation and learning. Customer-Centric Mindset: Prioritizes client needs and business value in project outcomes. Other Requirements: Travel Requirement: 25% travel to various locations in North America for internal collaboration or onsite for project execution. During large scale projects, the percentage could fluctuate. Adherence to corporate travel and entertainment policy is required. Key Accountabilities: 40% - Project Management Lead client projects using established project management best practices and internal processes to fit client needs within the scope of hardware and services sold. Facilitate collaborative planning sessions to define scope, objectives, deliverables, success metrics, risks, milestones, schedules, and resource requirements. Schedule and lead project meetings, ensuring alignment on timelines and deliverables. Monitor and report on project milestones, proactively addressing risks and potential delays. Conduct postmortem reviews to identify improvement opportunities. Communications Management Establish and maintain consistent communication with clients, business partners and internal stakeholders regarding deliverables, timelines, risks, and progress. Define and reinforce clear expectations throughout the project lifecycle. Proactively resolve issues, escalating to leadership as needed. Deliver weekly project summary updates to PMO leadership, project stakeholders and client teams. 30% - Process Management Maintain comprehensive documentation of all project artifacts, ensuring accuracy and version control. Archive project documentation upon completion for traceability and compliance. Enforce standardized reporting and monitoring procedures, aligning with PMO governance. Maintain up-to-date project records in PMO tracking systems (e.g., Smartsheet, Power BI, SharePoint, etc.) ensuring visibility into project status, dependencies, and performance metrics. 30% - Support the PMO in managing a portfolio of internal and customer-facing initiatives by contributing to the continuous improvement of project execution processes. Additional Information: At FastTek Global, Our Purpose is Our People and Our Planet. We come to work each day and are reminded we are helping people find their success stories . Also, Doing the right thing is our mantra. We act responsibly, give back to the communities we serve and have a little fun along the way. We have been doing this with pride, dedication and plain, old-fashioned hard work for 24 years! FastTek Global is a financially strong, privately held company that is 100% consultant and client focused, operating in nearly half of the states in the U.S., Europe and India. We've differentiated ourselves by being fast, flexible, creative and honest. Throw out everything you've heard, seen, or felt about every other IT Consulting company. We do unique things and we do them for Fortune 10, Fortune 500, and technology start-up companies. Our benefits are second to none and thanks to our flexible benefit options you can choose the benefits you need or want, options include: Medical and Dental (FastTek pays majority of the medical program) Vision Personal Time Off (PTO) Program Long Term Disability (100% paid) Life Insurance (100% paid) 401(k) with immediate vesting and 3% (of salary) dollar-for-dollar match Plus, we have a lucrative employee referral program and an employee recognition culture. FastTek Global was named one of the Top Work Places in Michigan by the Detroit Free Press in 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, and 2023! To view all of our open positions go to: ******************************************* Follow us on Twitter: ********************************* Follow us on Instagram: *************************************** Find us on LinkedIn: **************************************** You can become a fan of FastTek on Facebook: *************************************** AI & Hiring Disclosure We use AI tools to support parts of our hiring process, such as reviewing applications and identifying potential matches. These tools are designed to promote efficiency, consistency, and fairness, and they are always used under human oversight. All personal data collected is used solely for recruitment purposes, and you have the right to know, access, or request deletion of your data at any time, subject to legal limits. If AI will be used in a video interview, you'll be informed in advance and asked for your consent, with the option to opt out. Our tools are regularly reviewed to detect potential bias and to ensure compliance with all applicable laws and our commitment to inclusive hiring. To learn more or exercise your rights, please contact us at ****************.

The Senior Manager, Reimbursement Access will play a critical role in ensuring appropriate patient access to Xeris products by leading the Reimbursement Access team, shaping national access strategies, and supporting operational excellence across the function. The incumbent must have deep experience in reimbursement, patient access, and healthcare provider support services, and leadership experience that includes driving the execution of complex operations while developing a high performing team of Reimbursement Access Managers. Responsibilities Team Leadership & Talent Development Identify, recruit, onboard, and develop a high-performing team of Reimbursement Access Managers (RAMs) across key geographies. Provide coaching, mentorship, and performance management to drive effectiveness and professional growth. Lead field-based access teams to execute patient support strategies that improve access and affordability for patients. Reimbursement Strategy & Execution Collaborate with Patient Access leadership to design and implement innovative reimbursement access strategies that align with product and company goals. Analyze access barriers and develop field-based solutions to improve access to therapies for rare disease patients. Partner with internal teams (Commercial, Medical Affairs, Legal, Compliance) to ensure alignment and seamless execution of access initiatives. Operational Excellence Assist in developing standard operating procedures (SOPs), metrics, and reporting tools to evaluate and optimize the effectiveness of the Reimbursement Access function. Drive continuous improvement initiatives to ensure the highest standards of patient access and compliance. Monitor and assess reimbursement trends, payer coverage, and changes in access environment; provide recommendations to senior leadership. Stakeholder Engagement Serve as a strategic liaison between internal stakeholders and field reimbursement teams to ensure market and patient needs are addressed. Provide insights from the field to inform leadership decisions on payer strategy, patient affordability programs, and other access-related initiatives. Represent the company at relevant industry meetings, conferences, and with key external stakeholders as needed. Qualifications Bachelor's degree in business, healthcare, or related field (advanced degree preferred). Minimum of 7 years of experience in market access, reimbursement, patient services, or related pharmaceutical roles. Prior leadership experience managing field reimbursement teams strongly preferred. In-depth understanding of the reimbursement landscape including buy-and-bill, specialty pharmacy, payer dynamics, copay assistance, and HUB services. Experience in rare diseases or specialty biologics/therapies. Demonstrated ability to lead cross-functional initiatives in a fast-paced, entrepreneurial environment. Willingness to travel (up to 30%) to support field teams and stakeholders. Competencies: Leadership, Presentation skills, Written and Verbal Communications, Analytical skills, Problem Solving, Teamwork & Collaboration, Customer Service focus, Adaptability, Professionalism A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Ability to Travel up to 30%. Travel may include air and ground travel to HCP locations, and company meetings The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $130,000 to $220,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Senior Manager, Patient Access is responsible for managing the operational plans for all patient services tactics to support the Xeris product portfolio. This leadership role is responsible for assigned Xeris patient support responsibilities inclusive of reimbursement, financial, patient assistance, patient advocacy management and adherence support. The incumbent will manage daily operations of a team of field-based Patient Access Managers across geographically aligned regions. Responsibilities Manage patient services programs for Xeris products. Collaborate cross functionally to ensure successful implementation and long-term success of Patient Services' strategy and operations by understanding patient journey and best in class services required for excellence across reimbursement, financial support, patient advocacy and adherence. Embrace continuous improvement initiatives and innovative program enhancements throughout the program lifecycle. Proactively cultivate collaborative and productive relationships with a wide range of teams, including Marketing, Sales, Market Access, Legal, and Compliance to discuss service design and develop action plans for execution, in a constantly changing environment. Drive project management and execution for cross-functional Patient Services Projects. Act as a consistent liaison, point of contact and facilitator to enable appropriate discussions and projects between Patient Services, Brands, Training, IT, Commercial Operations, and other business partners and departments related to Patient Services' operational activities. Develop Patient Services CRM expertise; coordinate with IT and train internal and external end users. Serve as the Patient Services Lead in working with IT on the development of patient services systems, system upgrades, and reporting platform. Collaborate with Operations to monitor operational metrics and routinely monitor to identify changes in patterns. Coordinate with all applicable stakeholders, implement improvements and share best practices within patient services and across business units. Oversight and management of team performance to meet defined objectives. Provide strong people management to attract, coach and retain team of impactful and engaged Patient Access Managers. Create an environment of continuous learning where team members feel challenged and engaged. Foster team effectiveness within matrix team by sharing knowledge, experience, and information. Establish and/or further develop and continuously strengthen advocacy relationships with national and community organizations through compliant and thoughtful engagement in alignment with company business priorities and objectives. Identify opportunities for patients and patient advocates to participate in development of educational materials, review clinical study protocols and other documents and programs (e.g., informed consent, patient, and product services, etc.) Establish and help operationalize best practices for communicating with patients who reach out to Xeris proactively via phone, email, etc. in collaboration with personnel responsible for medical information. Communicate key learnings from the patient community to inform cross-functional (i.e. medical, clinical, and commercial) team strategies. Qualifications Bachelor's Degree in business administration, management, marketing, or equivalent experience preferred. A minimum of 7 years of experience in the pharmaceutical/healthcare environment, in roles involving patient advocacy, reimbursement, and marketing/sales, including previous patient access management experience. Ability to exhibit agility in an evolving environment. Decision support experience. Demonstrated knowledge of and ability to comply with HIPAA guidelines. Strong track record of driving results in a complex internal and external environment A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position. Competencies: Project Management, Relationship Management, Collaborative Team Leadership, Change Agility, Authentic Leadership, Talent Developer, Attention to Details, Presentation skills, Written and Verbal Communication skills Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a remote position and requires travel up to 25%. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $180,000 to $200,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Senior Manager, Reimbursement Access will play a critical role in ensuring appropriate patient access to Xeris products by leading the Reimbursement Access team, shaping national access strategies, and supporting operational excellence across the function. The incumbent must have deep experience in reimbursement, patient access, and healthcare provider support services, and leadership experience that includes driving the execution of complex operations while developing a high performing team of Reimbursement Access Managers. **Responsibilities** + **Team Leadership & Talent Development** + Identify, recruit, onboard, and develop a high-performing team of Reimbursement Access Managers (RAMs) across key geographies. + Provide coaching, mentorship, and performance management to drive effectiveness and professional growth. + Lead field-based access teams to execute patient support strategies that improve access and affordability for patients. + **Reimbursement Strategy & Execution** + Collaborate with Patient Access leadership to design and implement innovative reimbursement access strategies that align with product and company goals. + Analyze access barriers and develop field-based solutions to improve access to therapies for rare disease patients. + Partner with internal teams (Commercial, Medical Affairs, Legal, Compliance) to ensure alignment and seamless execution of access initiatives. + **Operational Excellence** + Assist in developing standard operating procedures (SOPs), metrics, and reporting tools to evaluate and optimize the effectiveness of the Reimbursement Access function. + Drive continuous improvement initiatives to ensure the highest standards of patient access and compliance. + Monitor and assess reimbursement trends, payer coverage, and changes in access environment; provide recommendations to senior leadership. + **Stakeholder Engagement** + Serve as a strategic liaison between internal stakeholders and field reimbursement teams to ensure market and patient needs are addressed. + Provide insights from the field to inform leadership decisions on payer strategy, patient affordability programs, and other access-related initiatives. + Represent the company at relevant industry meetings, conferences, and with key external stakeholders as needed. **Qualifications** + Bachelor's degree in business, healthcare, or related field (advanced degree preferred). + Minimum of 7 years of experience in market access, reimbursement, patient services, or related pharmaceutical roles. + Prior leadership experience managing field reimbursement teams strongly preferred. + In-depth understanding of the reimbursement landscape including buy-and-bill, specialty pharmacy, payer dynamics, copay assistance, and HUB services. + Experience in rare diseases or specialty biologics/therapies. + Demonstrated ability to lead cross-functional initiatives in a fast-paced, entrepreneurial environment. + Willingness to travel (up to 30%) to support field teams and stakeholders. + Competencies: Leadership, Presentation skills, Written and Verbal Communications, Analytical skills, Problem Solving, Teamwork & Collaboration, Customer Service focus, Adaptability, Professionalism + A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position. + Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. + Ability to Travel up to 30%. Travel may include air and ground travel to HCP locations, and company meetings _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-REMOTE _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $130,000 to $220,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US_ **Title** _Senior Manager, Reimbursement Access - West_ **ID** _2025-2168_ **Category** _Market Access_ **Type** _Full-Time_

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, 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.

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) **P** **hysical Demands and Work Environment** Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. **Education and Related Experience** Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **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 $146,955.00 - Maximum $219,650.00, 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.

What you will do: Reporting to the Executive Director, Service and Parts Operations, Global Data Center Solutions, the Global Customer Operations Director is a business partner and critical driver of execution across the Global Data Center Solutions (GDCS) service and parts operations teams. This leader owns oversight and the operating rhythms of workstream teams and works with workstream leaders to ensure timely completion of strategic initiatives. The Global Customer Operations Director must be comfortable holding other leaders accountable with effective communication and must also be able to provide executive updates on complex topics related to the overall Global Service & Parts Operations within GDCS. The role demands a high level of cross-functional coordination, strategic alignment, and performance tracking to support business growth and operational excellence across the Global Data Center Solutions (GDCS) organization. The Global Customer Operations Director has accountability and is a leader in supporting the organization's culture and success while scaling the Service & Parts strategy globally. This will be achieved by fostering collaborative relationships with key stakeholders both within JCI (e.g., Region Operations teams, Commercial data center team) as well as with Vice president and senior level customer counterparts. Understanding our customer's needs and incorporating them into our processes will be an important capability. As a leader in the Global Data Center Solutions organization, this person will have the opportunity to work closely with senior leaders across the portfolio to align efficient process rigor with Strategy, Technology, and Implementation. The Global Customer Operations Director is a unique opportunity for a high-performing candidate to share in the creation of sustainable value generation across Johnson Controls. This global leader will lead and manage a portfolio of initiatives to enable data center service and parts business growth, innovation and operational improvement within Johnson Controls. On a daily basis, the Global Customer Operations Director will interact with a broad range of functional and business partners to lead and implement initiatives driving transformational change. Work involved understanding critical strategic items and translating them to operations globally. How you will do it: Strategic business leader who deeply understands driving organization culture shifts to have a multiplier impact on people and business outcomes Design, develop and implement transformation strategies and practices that will enable measurable commercial and operational success Understand overall Johnson Controls Strategy and business unit/functional-unique priorities to ensure alignment and linkage between transformation and key strategic initiatives Experienced leadership influencer who builds strong relationships across the business and with cross-functional partners Advise business leaders on proactively managing stakeholders, including anticipating and mitigating risks and issues, navigating stakeholder interests/conflicts and prioritization, and facilitating alignment. Cultivate meaningful relationships with key stakeholder groups to enable excellence through transformed ways of working. Hold team members / Initiative Owners accountable for their deliverables in accordance to requirements and verifying completion of each deliverable Highly disciplined and accountable doer with a strong bias towards action Support and/or lead ad hoc project teams, as required What we look for: Requirements: BA / BS plus at least 10 years successful experience in business, transformation, organizational design or culture change management and stakeholder / community engagement, or related field or comparable experience Successful leadership of JCI Service and/or Parts operations and ability to develop and implement lasting change Demonstrated leadership of transformation initiatives working with key leaders in large, matrix management organizations Excellent interpersonal skills and ability to build relationships, manage stakeholders, and manage conflict at all levels of a global enterprise Outstanding verbal and written communication skills, with ability to create and communicate compelling messages to various stakeholders Demonstrated organizational skills, including project planning, project management and team building Ability to engage globally, understand and work effectively in a culturally diverse organization Ability to operate in a matrix organization and manage team members by influence Ability to think strategically and adapt quickly to new environment and demands Enjoy collaborating, building skills, and succeeding in a fast-paced environment Candidate must be well organized and capable of managing numerous competing priorities Desired Qualifications: Master's Degree (or equivalent) in relevant subject area Comfortable making decisions with incomplete information and navigating ambiguity and uncertainty Worked with, or within, key corporate functions such as transformation, operations in a large corporation. Willing to challenge others and be challenged Experience with a wide variety of structured problem-solving processes and reporting tools Experience of collaboration tools and digital platforms HIRING SALARY RANGE: $141,000 - 188,000 (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, location and alignment with market data.) This role offers a competitive Bonus plan that will take into account individual, group, and corporate performance. This position includes a competitive benefits package. For details, please visit the About Us tab on the Johnson Controls Careers site at ***************************************** Johnson Controls International plc. is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability or any other characteristic protected by law. To view more information about your equal opportunity and non-discrimination rights as a candidate, visit EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please visit here.

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, 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.

Cresco Labs is one of the largest public, vertically integrated, multistate operators in the cannabis industry. Our portfolio of in-house cultivated and manufactured brands features some of the highest quality, most awarded and most popular cannabis products in America. With dozens of locations nationwide, our owned and operated Sunnyside dispensaries provide a welcoming, positive, judgement-free place to shop for anyone at any point on their cannabis journey. Founded in 2013, Cresco Labs' mission is to normalize and professionalize cannabis through our passionate employees. As stewards of the cannabis industry, our teams are constantly focused on supporting the needs of our fellow colleagues, consumers, customers, and communities alike. With a focus on Social Equity and Educational Development, our SEEDTM initiative ensures that our company reflects the communities in which we serve, ensuring equal opportunity for all to have the knowledge and resources to work in and own businesses in cannabis. At Cresco Labs, we aim to revolutionize and lead the nation's cannabis industry with a focus on quality and consistency of product, and to bring legitimacy to the industry with the highest level of integrity and professionalism. If you're interested in joining our mission, click the below links to join our team today! MISSION STATEMENT At Cresco, we aim to lead the nation's cannabis industry with a focus on regulatory compliance, product consistency, and customer satisfaction. Our operations bring legitimacy to the cannabis industry by acting with the highest level of integrity, strictly adhering to regulations, and promoting the clinical efficacy of cannabis. As Cresco grows, we will operate with the same level of professionalism and precision in each new market we move in to. JOB SUMMARY Cresco Labs is seeking a Senior Document Center Manager to join our operations team. This is a remote role but will require travel to our Operations facilities in IL and other locations within Cresco's national facility network. You will be responsible for overseeing the Document Management Team and managing all documents related to facility operations across the enterprise, ensuring they are current and comprehensive. You will also be responsible for administrative functions, related to managing the Document Center Team. The ideal candidate must possess a strong attention to detail, be highly organized, be able to juggle multiple document changes and priorities, manage timelines and due dates, work collaboratively within a team, and has experience working within a highly regulated industry. CORE JOB DUTIES Lead the build and maintenance of SOPs and training infrastructure for Operations Facilities. Responsible for accuracy and completeness of the company's Operations SOPs and training materials. Oversee document lifecycle management, including updates, reviews, approvals, and archiving. Collaborate with Facility Management, Training, and Compliance teams to identify process gaps and documentation needs. Oversee deliverables, timelines, priorities, suppliers, and change control manager and approver workload to meet critical launch priorities and objectives. Conduct gap assessments and/or audit of documents and training related to new market or integration through merger and acquisition. Partner with cross-functional teams to manage deliverables, timelines, and priorities, ensuring key initiatives are executed effectively and launch deadlines are met. Oversee technical writers in developing detailed SOPs and instructional materials based on facility operations and IT systems. Identify opportunities to streamline content, reduce redundancy, and improve document usability. Provide documents as required for regulatory inspections, license applications, etc. Ensure all documentation meets state and company standards for periodic review and regulatory compliance. Identifies opportunities to streamline documents, content, volume of documents, automate, error proof. Work cross functionally among projects and departments as needs arise. REQUIRED EXPERIENCE, EDUCATION AND SKILLS Excellent written and verbal communication skills - detailed, user-friendly, and succinct writing. Ability to communicate clearly, concisely and professionally verbally and in writing. 5+ years' experience in manufacturing, preferably in a regulated industry with at least 2 of those in a management position. Required experience with a formalized change control and document management process, including reading and assessing regulatory requirements and guidelines. Required experience writing Standard Operating Procedures (SOPs) and training materials Collaborates effectively with senior leaders-driving results while demonstrating awareness of competing priorities. Highly flexible and adaptable - working in a fast-paced start-up involves daily shifting priorities; able to go with the flow and adjust to changing needs quickly Demonstrated ability to manage multiple high-priority projects and shifting deadlines. Travel required up to 10-15% annually to Operations Facilities and other Cresco locations as needed. BENEFITS Cresco Labs is proud to offer eligible employees a robust offering of benefits including, major medical, dental and vision insurance, a 401(K)-match program, FSA/HSA programs, LTD/STD options, life insurance and AD&D. We also offer eligible employees paid holidays and paid time off. Other rewards may include annual discretionary bonuses, stock options as well as participation in our employee discount program. Benefits eligibility for permanent positions may vary by full-time or part-time roles, location, or position. In accordance with any local and state compensation laws, the compensation listed is the current estimated range for the position. Final offer details and future compensation may be determined by multiple factors including but not limited to, geographic location, market compensation data, skills, experience, and other relevant factors. For questions about this please discuss with your recruiter during the interview process. Pay Range$90,000-$100,000 USD ADDITIONAL REQUIREMENTS Must be 21 years of age or older to apply Must comply with all legal or company regulations for working in the industry Cresco Labs is an Equal Opportunity Employer and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. California Consumer Privacy Act ("CCPA") Notice to Applicants:Please read the California Employee Privacy Notice ("CA Privacy Notice") regarding Sunnyside* and its affiliate Cresco Labs' policies pertaining to the collection, use, and disclosure of personal information. This CA Privacy Notice supplements the information contained in the Sunnyside* Privacy Policy and applies to California resident employees and job applicants. Applicants with disabilities may access this notice in an alternative format by contacting ************************* Reporting a Scam: Cresco Labs is aware of fictitious employment offers being circulated from various sources. Many of these schemes consist of an alleged offer of employment with Cresco Labs with the intention of gaining personal information, including payment and/or banking information. Be aware that fraudulent job offers and correspondence may appear legitimate: they may feature a Cresco Labs logo, they may appear to originate from an official-looking email address or web site, or they may be sent by individuals purporting to represent Cresco Labs or an entity which includes the word Cresco Labs in its name. Please note that Cresco Labs does not ask for payment or personal banking information as a condition of employment. Any personal information is requested for payroll or state badging purposes only. Applications can be securely submitted through our career's pages.We are working diligently to block this from happening. Beware if an offer of employment looks too good to be true. Never divulge personal and banking information or send money if you are unsure of the authenticity of an email or other communication in the name of Cresco Labs.If you are in doubt, please contact us at **************************** with questions.

Cresco Labs is one of the largest public, vertically integrated, multistate operators in the cannabis industry. Our portfolio of in-house cultivated and manufactured brands features some of the highest quality, most awarded and most popular cannabis products in America. With dozens of locations nationwide, our owned and operated Sunnyside dispensaries provide a welcoming, positive, judgement-free place to shop for anyone at any point on their cannabis journey. Founded in 2013, Cresco Labs' mission is to normalize and professionalize cannabis through our passionate employees. As stewards of the cannabis industry, our teams are constantly focused on supporting the needs of our fellow colleagues, consumers, customers, and communities alike. With a focus on Social Equity and Educational Development, our SEEDTM initiative ensures that our company reflects the communities in which we serve, ensuring equal opportunity for all to have the knowledge and resources to work in and own businesses in cannabis. At Cresco Labs, we aim to revolutionize and lead the nation's cannabis industry with a focus on quality and consistency of product, and to bring legitimacy to the industry with the highest level of integrity and professionalism. If you're interested in joining our mission, click the below links to join our team today! MISSION STATEMENT At Cresco, we aim to lead the nation's cannabis industry with a focus on regulatory compliance, product consistency, and customer satisfaction. Our operations bring legitimacy to the cannabis industry by acting with the highest level of integrity, strictly adhering to regulations, and promoting the clinical efficacy of cannabis. As Cresco grows, we will operate with the same level of professionalism and precision in each new market we move in to. JOB SUMMARY Cresco Labs is seeking a Senior Document Center Manager to join our operations team. This is a remote role but will require travel to our Operations facilities in IL and other locations within Cresco's national facility network. You will be responsible for overseeing the Document Management Team and managing all documents related to facility operations across the enterprise, ensuring they are current and comprehensive. You will also be responsible for administrative functions, related to managing the Document Center Team. The ideal candidate must possess a strong attention to detail, be highly organized, be able to juggle multiple document changes and priorities, manage timelines and due dates, work collaboratively within a team, and has experience working within a highly regulated industry. CORE JOB DUTIES Lead the build and maintenance of SOPs and training infrastructure for Operations Facilities. Responsible for accuracy and completeness of the company's Operations SOPs and training materials. Oversee document lifecycle management, including updates, reviews, approvals, and archiving. Collaborate with Facility Management, Training, and Compliance teams to identify process gaps and documentation needs. Oversee deliverables, timelines, priorities, suppliers, and change control manager and approver workload to meet critical launch priorities and objectives. Conduct gap assessments and/or audit of documents and training related to new market or integration through merger and acquisition. Partner with cross-functional teams to manage deliverables, timelines, and priorities, ensuring key initiatives are executed effectively and launch deadlines are met. Oversee technical writers in developing detailed SOPs and instructional materials based on facility operations and IT systems. Identify opportunities to streamline content, reduce redundancy, and improve document usability. Provide documents as required for regulatory inspections, license applications, etc. Ensure all documentation meets state and company standards for periodic review and regulatory compliance. Identifies opportunities to streamline documents, content, volume of documents, automate, error proof. Work cross functionally among projects and departments as needs arise. REQUIRED EXPERIENCE, EDUCATION AND SKILLS Excellent written and verbal communication skills - detailed, user-friendly, and succinct writing. Ability to communicate clearly, concisely and professionally verbally and in writing. 5+ years' experience in manufacturing, preferably in a regulated industry with at least 2 of those in a management position. Required experience with a formalized change control and document management process, including reading and assessing regulatory requirements and guidelines. Required experience writing Standard Operating Procedures (SOPs) and training materials Collaborates effectively with senior leaders-driving results while demonstrating awareness of competing priorities. Highly flexible and adaptable - working in a fast-paced start-up involves daily shifting priorities; able to go with the flow and adjust to changing needs quickly Demonstrated ability to manage multiple high-priority projects and shifting deadlines. Travel required up to 10-15% annually to Operations Facilities and other Cresco locations as needed. BENEFITS Cresco Labs is proud to offer eligible employees a robust offering of benefits including, major medical, dental and vision insurance, a 401(K)-match program, FSA/HSA programs, LTD/STD options, life insurance and AD&D. We also offer eligible employees paid holidays and paid time off. Other rewards may include annual discretionary bonuses, stock options as well as participation in our employee discount program. Benefits eligibility for permanent positions may vary by full-time or part-time roles, location, or position. In accordance with any local and state compensation laws, the compensation listed is the current estimated range for the position. Final offer details and future compensation may be determined by multiple factors including but not limited to, geographic location, market compensation data, skills, experience, and other relevant factors. For questions about this please discuss with your recruiter during the interview process. Pay Range$90,000-$100,000 USD ADDITIONAL REQUIREMENTS Must be 21 years of age or older to apply Must comply with all legal or company regulations for working in the industry Cresco Labs is an Equal Opportunity Employer and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. California Consumer Privacy Act (“CCPA”) Notice to Applicants: Please read the California Employee Privacy Notice (“CA Privacy Notice”) regarding Sunnyside* and its affiliate Cresco Labs' policies pertaining to the collection, use, and disclosure of personal information. This CA Privacy Notice supplements the information contained in the Sunnyside* Privacy Policy and applies to California resident employees and job applicants. Applicants with disabilities may access this notice in an alternative format by contacting ************************* Reporting a Scam: Cresco Labs is aware of fictitious employment offers being circulated from various sources. Many of these schemes consist of an alleged offer of employment with Cresco Labs with the intention of gaining personal information, including payment and/or banking information. Be aware that fraudulent job offers and correspondence may appear legitimate: they may feature a Cresco Labs logo, they may appear to originate from an official-looking email address or web site, or they may be sent by individuals purporting to represent Cresco Labs or an entity which includes the word Cresco Labs in its name. Please note that Cresco Labs does not ask for payment or personal banking information as a condition of employment. Any personal information is requested for payroll or state badging purposes only. Applications can be securely submitted through our career's pages. We are working diligently to block this from happening. Beware if an offer of employment looks too good to be true. Never divulge personal and banking information or send money if you are unsure of the authenticity of an email or other communication in the name of Cresco Labs. If you are in doubt, please contact us at **************************** with questions.

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Global Manager, Beef Sustainability and Farm Animal Sustainability Operations As the Global Manager, Beef Sustainability and Farm Animal Sustainability Operations you will be a critical leader responsible for developing and executing the beef sustainability strategy in key markets, while also driving the development of robust governance frameworks, processes, and business principles to ensure the credibility and integrity of Elanco's sustainability initiatives and protect the brand. This role will spearhead the identification, design, and monetization of GHG reduction opportunities for beef. You will lead a cross functional team dedicated to advancing Elanco's 4-Pillar Sustainability Strategy (Innovation, Analytics, Value Creation & Advocacy), ensuring economic viability for producers and delivering on key environmental outcomes. Your Responsibilities: Global Sustainability Governance & Strategy: Develop, implement, and oversee global governance frameworks, processes, guidelines, and business principles for all farm animal sustainability programs. Ensure consistency, credibility, and compliance with internal and external standards, safeguarding the Elanco brand and delivering measurable outcomes. Global Beef Sustainability Strategy & Execution: Create and drive the overall global beef sustainability strategy, identifying key opportunities for GHG reduction and value creation within the beef sector. Partner closely with local commercial teams in key geographies to execute strategic initiatives, and collaborate with the monetization team to identify potential buyers and develop compelling carbon projects. This role will work across functions to ensure the successful implementation and advancement of Elanco's beef sustainability goals including the EKS and carbon project management teams. Business Value Creation: Ensure robust business strategies and value propositions for Elanco, customers, and partners when deploying funding allocations or launching new sustainability-focused products and services. What You Need to Succeed (minimum qualifications): Experience: 12+ years of progressive experience in sustainability, marketing, or business development within the animal health or agriculture sector, with a significant portion in a global leadership or managerial role. Proven in developing and implementing governance frameworks, processes, or business principles for complex global programs. Top skills include strong leadership experience, including managing cross-functional teams and projects in a complex, fast-paced global environment, and exceptional strategic thinking, leadership, and communication skills (written and oral), with the ability to influence at all levels. This includes the ability to navigate ambiguity, manage complexity, and drive results independently and through others. Deep understanding of global food animal production systems across various species (e.g., beef, dairy, poultry, swine). What Will Give You a Competitive Edge (preferred qualifications): Experience with carbon market development and implementation. Extensive understanding of global food supply chain certification and processes. Strong financial acumen, negotiation skills, and consultative selling experience, particularly in a Strategic Account Management context with large organizations and buyers. Entrepreneurial mindset with a passion for advancing sustainable animal agriculture globally. Master's degree in a relevant field (e.g., Animal Science, Environmental Science, Business, Marketing, Public Policy). Additional Information: Travel: Up to 30% (global). Location: Global Elanco Headquarters - Indianapolis IN - Hybrid Work Environment Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status