Within this role you will be responsible for the design and configuration of the Manufacturing Execution Systems (MES) manufacturing batch records and equipment data. The successful individual is responsible for eliciting and documenting manufacturing business processes requirements As a MES Operations Analyst a typical day might include, but is not limited to, the following Designing and deploying MES system (Werum's PAS-X) to replace paper based process or manual processes in the processing areas Coordinating the needs of functional departments and establishes priorities for MES user requirements gathering, system design and implementation Participating in project deliverables such as review of company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess requirements for designing electronic records Designing and developing MES recipes, workflows, equipment, master data and electronic batch records to meet the requirements of the Business, specifically Manufacturing and QA Participating in the creation and testing of MES related protocols Maintaining MES design documentation in a state compliant to GAMP 5 throughout the system's life cycle Processing system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated state Liaising with Technical Trainers to develop training plans for MES users Providing end-user support for the MES including troubleshooting problems on the floor and work closely with IT to troubleshoot problems Implementing strategies to improve process efficiencies This role might be for you if: You demonstrate knowledge and experience of MES preferably Werum PAS/X You possess logical troubleshooting and problem-solving skills You have excellent analytical, written and oral communication skills You demonstrate an ability to work within a successful team To be considered for this opportunity you should have a BS/BA/BEng in a technical discipline, with 0-2 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience. #REGNIELSM #JOBSIEST #REGNIEEC Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Please copy and paste the desired job description for this role here. If you need a copy of an existing job description please reach out to TA or work with your HR Business Partner to develop one for a new role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This role is a hybrid role on-site 3 days per week and 2 days from home. A fully remote role is not possible. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensurestimely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Acts as point of contact for clinical program and study level escalation Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress Provide proactive creation and implementation of risk mitigation strategies Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges Drive the strategy and oversight for vendor selection and management within a clinical program(s) Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts To be considered, you must possess a Bachelor's degree, and minimum of 12 years relevant industry experience, 8 years within clinical trial management. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $198,000.00 - $330,000.00
The Senior Mgr Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Sr Mgr CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. Responsible for direct line management responsibilities. This role requires a minimum of 3-days onsite and is not eligible fully remote. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified for this role, you must possess a Bachelors' degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00
The Senior Manager Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role has a 3-day onsite minimum requirement and is not eligible remote. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified for this role, you must possess a Bachelors' degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00
As a Sr. Manager Global Procurement you will support and assist in the development and implementation of the our Global Clinical Category Management strategy by gathering and anticipating business supply needs and specifications. We aim to manage a supply base and enhance value, minimize risk, and ensure quality & cost effectiveness by working collaboratively with business unit. A typical day may include the following: Collaborating with partners leading discussions related to the Global Clinical Category strategies and aligns category priorities. Manages negotiations, supplier management activities, and partner engagement activities Drives value in terms of cost savings, cash flow improvement, and other efficiency savings. Represents Global Procurement by participating in organizational decisions in Global strategies with critical short and long-term impact on the success, efficiency, growth, and results. Demonstrates knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and evolution of the organization and leverages this knowledge to drive improvements aligning with corporate priorities. Manages category activities to ensure compliance with appropriate GxPs and other applicable regulations, as applicable. Negotiates contract terms and conditions in consultation with Law department aligned with Regeneron's priorities and business requirements. May, either directly or through a matrix structure, manage team of professional level employees responsible for performing category management tasks (if applicable.) Uses data to drive decision-making for successful category projects. Coaches proficiency on procurement technical skills among global procurement team. This may be for you if you Can build relationships with collaborators and suppliers to drive results for Regeneron. Use external data sources, market information, and supplier engagement to continuously improve your knowledge of supply market dynamics. Operate with integrity, focus, and clarity in an environment of ambiguity to lead change and improvement. Want to have an impact on patient lives To be considered you are to have a bachelor's degree in a relevant field of study plus relevant, progressive experience in procurement, including experience in Pharma/BioPharma. Experience successfully managing clinical category processes, and suppliers across a breadth of categories is required. Your experience will include demonstrated success working effectively with cross-functional teams through effective sourcing, negotiations, contracting, and supplier relationship management. Additional experience required: Knowledge regarding rates, unit costs, and costing structures. Global supply market evaluation processes using all available market intelligence, risk, compliance, and financial assessment tools. Working knowledge with sourcing contracting tools, ERP's, and eRFx systems preferred. (Oracle, Zycus, Ariba, Other) Experience managing associate level professionals preferred Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $129,800.00 - $211,800.00
The Manager, Global Procurement - Global Development will be responsible for supporting and assisting in the development and implementation of the Global Clinical Category Management strategy by gathering and anticipating business supply needs and specifications. We are looking for someone who can be a business strategy influencer & collaborator to advise our Clinical Operations teams around market supply dynamics and leading practices. The ideal candidate will be able to proactively manage a supply base and maximize value, minimize risk, and ensure quality & cost effectiveness by working collaboratively with their colleagues & business partners. This is an opportunity to work in a growing, dynamic environment where you'll leverage your Procurement & Category Management experience to anticipate future business requirements for Regeneron's growing clinical pipelines. A typical day may include: Accountable for supporting the definition and implementation of the Global Clinical Category strategies to serve global and regional business needs. Works closely with stakeholders to manage discussions related to the Global Clinical Categories and aligns category priorities with Procurement management and stakeholders. Leverages analytical and negotiation skills to drive cost competitiveness. Enables decision making by providing financial insights and recommendations. Takes direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from study management activities. Supports Global Procurement by participating in organizational decisions in the Global Clinical categories with critical short and long-term impact on the success, efficiency, growth, and results of the study team. Demonstrates knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and evolution of the Global Procurement organization and leverages this knowledge to drive improvements within Regeneron, aligned with corporate priorities. Manages category study activities to ensure compliance with appropriate GxPs and other applicable regulations, as applicable. Negotiates contract terms and conditions in consultation with Law department aligned with Regeneron's priorities and business requirements, as needed. May either directly or through a matrix structure, manages teams of professional level employees responsible for performing category management tasks (if applicable.) Uses data to drive decision-making for successful category study projects. This role may be for you if: You have demonstrated experience working across multiple spend categories within a strategic sourcing team Sophisticated negotiations skills and proficiency utilizing data to build business cases Cost modeling knowledge Excellent verbal and written communication skills, with an ability to build consensus across a diverse, collaborative team with limited supervision Program / project management experience Enjoy building influential relationships with stakeholders and suppliers to drive results You operate with integrity, focus, and clarity and can be inspired in an evolving working environment Ability to leverage standard business applications for communicating, presenting and analyzing data (Word, Excel, PowerPoint) You want to have an impact on the future of a growing Global Procurement team. To be considered for this position you must possess a bachelor's degree in a relevant field of study plus progressive experience in procurement, including experience in Pharma/BioPharma. Experience successfully managing category processes, and suppliers across a breadth of categories. Working knowledge with sourcing contracting tools, ERP's, and eRFx systems preferred. (Oracle, Zycus, GEP, Ariba, Other). Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $113,100.00 - $184,700.00
This role is a hybrid role on-site 3 days per week and 2 days from home. A fully remote role is not possible. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensurestimely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Acts as point of contact for clinical program and study level escalation Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress Provide proactive creation and implementation of risk mitigation strategies Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges Drive the strategy and oversight for vendor selection and management within a clinical program(s) Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts To be considered, you must possess a Bachelor's degree, and minimum of 12 years relevant industry experience, 8 years within clinical trial management. Oncology experience is required. Experience with early stage oncology assets is highly preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $202,000.00 - $336,600.00
Our Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise. As Regeneron has recently expanded with offices throughout Europe, Canada and Japan, the need for a strong leader who is able to manage various Country Medical Directors, work cross functionally primarily with Commercial and Market Access Partners and accelerate the pipeline with our clinical development colleagues has emerged. This leader will work in the Oncology organization but will also support future pipeline assets as they emerge. There will be further support provided to indirect market distributors as well throughout the world. The role has significant growth opportunity therefore. The ability to work with a "start-up mindset" is key as the offices are new and continuing to grow & evolve. This position is based in Dublin, Ireland at a regional headquarters office as the selected individual will work closely with the Head of Commercial Oncology, International and Head of Market Access, International with a need for co-location. Furthermore, the Head of Regulatory Affairs, International and other senior leaders for the international roles are also present there. A typical day might include the following: Representing Regeneron in its Medical Affairs and Clinical Development functions globally, excluding the USA. Overseeing and evolving a newly formed international team, bringing innovation and critical thinking to Medical Affairs processes. Providing scientific and medical leadership, understanding therapeutic areas, and serving as a key medical resource to internal and external stakeholders. Ensuring alignment of medical/clinical activities with global strategies and goals, including joint strategies with alliance partners. Collaborating with internal colleagues within Medical Affairs, Clinical Sciences, Clinical Operations, Regulatory, and Commercial. Ensuring all activities adhere to corporate standards and government/industry regulations. Leading international strategic/operational excellence for Oncology and managing other therapeutic areas as they arise. Supporting clinical development and research, identifying medical centers of excellence, and maintaining deep scientific and medical knowledge. Engaging with external communities to advance scientific and medical understanding. Acting as an effective Regeneron representative at professional/medical meetings. Developing medical strategy and content for congresses, symposia, and advisory boards. Providing medical guidance and support to clinical research field operational teams. Assessing medical education needs and developing educational strategies. Ensuring countries can deliver and execute local medical plans aligned with global strategies. This role is for you if you... are a strategic leader with a breadth of global industry-related experience and strong business acumen. thrive in a multifunctional, matrix organization and can align international activities with global strategies. possess excellent people leadership skills and can foster professional development and growth of direct reports. are a proactive self-starter who can lead work and manage others independently. have strong interpersonal skills, including motivational, negotiation, listening, judgment, analytic, and conflict management skills. can work effectively in a fast-paced, rapidly changing environment and engage in collaborative decision-making. To be considered, you have a medical degree (Physician, M.D. or equivalent) with commensurate pharmaceutical/biotech industry experience; Medical Affairs experience is required. You have a strong working knowledge of Medical Affairs and Clinical Development business in Europe, with a thorough understanding of the European healthcare environment. You have oncology experience; and other disease areas are a plus. You have a strong background in drug development and life-cycle development of related products. Experience working in a matrix, cross-functional environment and in alliance relationships is very important and helpful. You can cultivate and maintain relationships with key internal and external stakeholders. In addition, you have excellent presentation and communication skills with fluency in English and you're willing to travel 25-35% of the time. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
We are seeking a dedicated Senior Specialist - Global Procurement R&D to join our dynamic team. In this role, you will support the development and implementation of Category Management strategies, ensuring alignment with global and regional business needs. You will work closely with team members to drive value through effective sourcing, negotiations, and supplier management, contributing to the success and growth of our Global Clinical Categories. We are committed to making a significant impact in oncology, and with your expertise, we will achieve our goals together. Join us and be part of a team where we value innovation, collaboration, and excellence. A Typical Day may include: Supporting the definition and implementation of Global Clinical Category strategies. Collaborating with stakeholders to align category priorities with procurement management. Engaging in negotiations and supplier management activities. Providing insights on rates, unit costs, and costing structures for efficient negotiations. Using external data sources and market information to improve supply market knowledge. Ensuring compliance with GxPs and other applicable regulations. Bringing to bear standard business applications for communication, presentation, and analysis. This Role May Be For You: You excel in environments of ambiguity and motivate change with integrity and focus. You have a knack for forming relationships with team members and suppliers. You are passionate about supporting cross-functional teams to achieve results. You are proficient with sourcing contracting tools, ERPs, and eRFx systems (e.g., Oracle, Zycus, Ariba) and are adept at using data to drive decision-making and project success. To Be Considered: The ideal candidate will have a bachelor's degree in a relevant field and over 5 years of progressive experience in procurement, particularly within the Pharma/BioPharma industry. Experience in supporting global category teams and processes, along with a proven track record in effective sourcing, negotiations, and supplier relationship management, is essential. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
