Overview Within this role you will be responsible for a wide variety of bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment. As a QC Analyst in the Gel's Lab, a typical day might include, but is not limited to the following: Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforms to company policies and standard operating procedures (SOPs) Reviewing data from other analysts for accuracy and completeness Performing gels/separations assays (CE-SDS/SDS-PAGE, iCIEF, PICO MCE, Western Blot) in compliance with cGMP practices Performing data processing using Empower Maintaining laboratory reagents and supplies Preparing reagent aliquots and buffers for use in assays Maintaining equipment in the laboratory Conducting laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT Initiating and completing CAPAs in accordance with site procedures Writing new and updates current SOPs as needed Presenting bioanalytical data reports clearly and concisely to management Identifying and implementing lab process improvements, lean initiatives Performing any other duties relevant to the QC laboratory position as required This role might be for you if: You have current or prior experience working with Gel based Assays You have a proven ability to work independently or as part of a team You possess strong trouble-shooting and problem solving skills You have strong attention to detail & excellent written and oral skills To be considered for this opportunity you must hold a BS/BA in Life Sciences or related field or an equivalent combination of education and experience with 2+ years' experience working in a regulated testing environment. Previous experience working in a regulated Biotech environment is a distinct advantage. 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. #J-18808-Ljbffr
Overview The Senior Manager, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, typically carrying out responsibilities with minimal guidance. Leads development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle. Responsibilities Manages the Regulatory labeling process throughout the product lifecycle. Leads the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and RoW labeling. Manages complex programs with minimal support from the Labeling Director. Leads development of labeling strategies through interpretation of labeling regulations, guidelines and competitor analyses, and application to product situation. Leads the development of target labeling documents to support the design and analysis plan for clinical trials, with guidance from the Labeling Director. Leads or contributes to discussions on labeling topics at relevant management interactions. Effectively communicates labeling rationales to various levels of management to enable decision making. Provides labeling expertise on complex issues to stakeholders. Anticipates Health Authority (HA) perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk. Communicates consequences to product portfolio. Prepares submission-ready labeling documents. Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate. Contributes to the development of the Regulatory Labeling Group through active knowledge sharing and mentoring of junior staff members to build labeling expertise. Monitors worldwide regulation changes pertaining to Labeling regulations and maintains the labeling SOP and work instructions. May be responsible for leading or contributing to various continuous improvement projects. This role might be for you if you have the: Ability to think strategically, assess risks and propose strategies to manage risk. Ability to lead Labeling Working Groups to address labeling issues, develop plans of action, and oversee completion of complex labeling projects. Expert knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines. Ability to assimilate clinical and scientific information and present it in a concise manner. Ability to work independently and use judgment to make decisions and escalate problems appropriately. Proactively share information with peers and generate discussion to resolve complex issues. Ability to handle multiple projects and prioritize work independently. Ability to operate in ambiguous situations and provide functional guidance to others. Attention to detail and strong word processing skill. To be considered for this opportunity, you must have the following: At minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences. An advanced degree (Masters, Pharm D, Ph.D, MD or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements. 3-4 years of related Biotech or Pharma industry experience, 2 or more of which are working with labeling is preferred. In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process. Familiar with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies. 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. Salary Range (annually) $148,300.00 - $241,900.00 Benefits: Work From Home #J-18808-Ljbffr
Overview Within this role you will be responsible for specifies instrumentation for biopharmaceutical process & utilities systems and supports all aspects of the site calibration program. Evaluates new instrumentation for functional equivalence to existing instrumentation. Supports authoring and maintains configuration specifications & standards for cGMP manufacturing instrumentation. Responsibilities Understanding of common process & utilities instrumentation including but not limited to load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers and level sensors Evaluating & specifiying cGMP instrumentation for new installations & for the upgrade of existing instrumentation with additional functionality, including instrument components & spare parts Being the technical SME for the site calibration program, providing technical guidance to calibrations operations team and supporting regulatory body inspections and audits Evaluating new instrumentation for Functional Equivalence to existing instrumentation that has become obsolete Implementing corrective/preventative actions for existing instrumentation Working knowledge of process automation control systems Conducting troubleshooting and root cause analysis for complex instrumentation and associated systems Creating and maintaining configuration specifications for cGMP manufacturing instrumentation Assisting in the design review of equipment, and approved supplier lists for instrumentation Reviewing and approval of wiring diagrams for instrumentation & associated control systems Preparing engineering evaluations and test plans for change control documentation Writes and executes test plans to demonstrate instrument suitability Supervising engineering contractors, may be required Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by ensuring compliance with applicable regulatory authority requirements This role might be for you if You possess logical troubleshooting and problem-solving skills You have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally You have strong analytical and organisational skills To be considered for this opportunity you must hold a BEng/BS along with 5+ years experience for Senior Engineer level and 8+ years experience for Principal Engineer level. Experience with Biopharmaceutical Process & Utilities systems is preferred. REGNIRLTO 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. #J-18808-Ljbffr
Overview 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 our International locations, we are seeking for a strong leader who is able to manage the Country Medical Directors in these different markets, to develop and execute on local medical affairs strategies to support the Oncology franchise needs in alignment with the Global Medical affairs Oncology Franchise strategies, and adapted to local market needs. For this intent, the role will closely partner with the Oncology Global Medical Affairs Franchise Head and the global Oncology medical leads. Importantly, this role will establish strong partnership with the International Commercial and Market Access Partners and contribute to accelerating the pipeline by supporting our clinical development programs. This leader will cover all markets for the Oncology franchise; direct and indirect; and will also support future pipeline assets as they emerge to address their needs across pre-launch, launch, life cycle management, and in-market. Ability to work with a "start-up mindset" is key as the offices are new and continuing to grow and evolve. The selected individual will work closely with the Heads of Commercial International, Market Access, and Regulatory Affairs, including other key senior leaders within the international organization. A typical day A typical day might include the following: #J-18808-Ljbffr
As a Compliance Specialist within QC you will support the QC organisation in meeting compliance targets through laboratory investigation and deviation management. The Compliance Analyst will report quality system metrics to the group and identify improvements that can be made in all quality system inputs. Responsibilities Coordinating and managing preparation for regulatory inspections and internal audits, ensuring QC is audit ready at all times Acting as the primary QC point of contact during inspections or audits, addressing inquiries and providing documentation as needed Organizing and maintaining QC quality records, including Change Controls, CAPAs, and Workflows Leading cross-functional teams during Change Control or CAPA events, ensuring alignment on strategies and resolution plans Reviewing, editing and revising controlled documents to ensure compliance with written procedures and regulatory standards Monitoring open compliance records, such as CAPAs, Change Controls, and Workflows, to ensure timely resolution and closure Reporting quality system metrics to QC teams and other relevant departments to track performance and identify improvement areas Representing QC in interdepartmental teams and meetings, ensuring QC perspectives and requirements are considered Performing other duties assigned by QC management, demonstrating flexibility and a broad understanding of QC functions Qualifications You thrive in a multifaceted and fast-paced environment You possess excellent verbal and written communication skills You enjoy collaboration with cross functional groups You successfully build and develop strategic partnerships You demonstrate an ability to work within a successful team To be considered for this opportunity you should have a BS/BA in Life Sciences or equivalent with 2+ years relevant experience, preferably in the pharmaceutical or biotechnology industries. Apply and Company Information 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.S. 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. #J-18808-Ljbffr
Overview Within this role you using project management techniques and experience, the Project Specialist leads well-defined Quality Control projects. The Project Specialist may additionally support, plan and coordinate operational tasks for other QC projects under the guidance of a Project Manager. This is a 12-month temporary contract. Responsibilities Acting as a lead on at least 1 well-defined QC project or molecule-based program and is responsible for: Coordinating meetings and creating agendas, minutes and managing action items Gathering / compiling data and project information Tracking project deliverables through management of tools, e.g. dashboards, MS Project, etc Ensuring effective communication of project deliverables up and across the QC Identifying risk and developing mitigation strategies with input from manager and/or QC responsible parties Utilizing project management best practices to ensure Quality Control meets timeline for project/program deliverables while ensuring quality Developing and communicating strategy, deliverables and timelines within QC Serving as primary point of contact for QC on cross-functional teams to facilitate the advancement of projects Proactively identifies team performance issues and works to resolve Utilizing project management techniques to identify, develop and maintain best practices, templates and planning tools (spreadsheets, MS Project, etc.) in support of projects and standardization across QC-PM Leveraging proficient understanding of QC-PM processes and tools to manage project work Developing excellent communication and working relationships with QC personnel responsible for deliverables as well as cross-functional team members Identifying continuous improvement and lessons learned opportunities to the team and implements solutions Qualifications and candidate profile This role might be for you if: You contribute to knowledge sharing and process improvement You possess strong communication skills You are diligent in maintaining accurate records You thrive in a collaborative team setting To be considered for this opportunity you should have a BS/BA in related field required with a minimum of 2 years of relevant experience or equivalent combination of education and experience. About the role and benefits 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! Equal Employment Opportunity and background checks 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. #J-18808-Ljbffr
Within this role, you will ensure compliance with international trade regulations while managing import/export operations. Key responsibilities include reviewing and validating harmonized tariff classifications under IE and EU commodity codes, maintaining trade documentation, and resolving customs and entry-related issues. You will collaborate with internal teams and external partners to uphold compliance standards, manage Trade Compliance Manuals, and assist with permits and AEO applications. Acting as the primary contact for trade functions, you will liaise with regulatory bodies, audit filings, and provide training to keep the business aligned with trade practices. A typical day might include, but is not limited to, the following: Reviewing harmonized tariff classifications under IE and EU commodity codes, and additional export/import commodity control classifications for all formulated drug substance products and raw materials as necessary, including collaboration within the organization, brokerage, and vendors/partners. Maintaining and managing all import and export documentation records in line with trade compliance best practices. Managing customs and entry-related issues effectively. Supporting international transportation and shipping processes with necessary documentation. Updating Export and Import Trade Compliance Manuals regularly. Assisting the business with export or import permits, AEO applications, and designation approvals. Acting as the primary point of contact for all tactical trade-related functions, including managing Freight Forwarders and Customs Brokers for Regeneron Ireland and conducting regular audits, reconciliations, and disclosures. Liaising with IE Revenue and the Department of Agriculture to resolve issues and ensure compliance. Creating Trade Compliance-related SOPs as required. Providing periodic training on Trade Compliance to the business. Advising the business on trade regulatory changes, updates, and current trade practices. Knowledge and Skills: Knowledge of Export, Import procedures, Revenue Customs documentation, etc. Ability to handle Customs and entry related issues Ability to manage relationships with Freight Forwarders and Customs Brokers Current knowledge of trade compliance best practices To be considered for this opportunity, you should hold a BS/BA/BEng in a related field, though equivalent industry experience may be considered in place of formal education. Additionally, a minimum of 3 years' experience in customs brokerage or trade compliance practices is required, ideally within the pharmaceutical industry. #REGNIELSM #JOBSIEST 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.
As a QC Analyst you will perform a wide variety of analytical chemistry testing to support in-process and bulk drug substance manufacture in a cGMP regulatory environment. . Please note this is a 24/7 shift position. The successful candidate will be required to work shift which includes days & nights. A typical day might include, but is not limited to, the following: Gathering data and documenting test results Reviewing test results to ensure compliance with standards; reports any quality anomalies Complying with all pertinent regulatory agency requirements Participating in required training activities Maintaining laboratory supplies Conducting testing on raw materials, in-process, product, stability, and/or research samples Writing and revising control test procedures and SOPs Completing test records and reviewing data Calibrating or verifying calibration of instruments/devices prior to use Interacting with outside customers or functional peer groups Owning the responsibility for maintaining a specific project Devising or developing new analytical methods and techniques Assisting in validation of methods Participating in establishing the transfer of methodology from R&D This role might be for you if: You enjoy working a shift pattern You have a proven ability to work independently or as part of a team You possess strong trouble-shooting and problem solving skills You have strong attention to detail & excellent written and oral skills To be considered for this opportunity you should have a BS/BA in Life Sciences or related field along with 2+ years of relevant experience. #REGNQC #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.
The Senior 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 is not eligible fully remote. This role is required to be onsite in one of our locations. (Armonk, NY / Warren, NJ / Cambridge, MA / Dublin, Ireland / Uxbridge, London) 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, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. A background in clinical trials within cell therapy 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) $148,300.00 - $241,900.00
As a member of our HR Technology team, you will play a key role in shaping and supporting a world class digital employee experience for our people. In this role, you'll act as a core part of the HR Technology team working across a wide variety of functional HR domains and partner with our Technology team to help design, deliver and support world-class technology enabled HR processes Our team partners closely with HR Centers of Excellence (COE), HR Business Partners and our HR Operations team, to understand their challenges and strategic priorities. We combine innovative HR process and operational support experience, with a strong appreciation of HR technology capabilities, to help these partners define their vision and business requirements. In collaboration with our IT partners, we provide the introduction, optimization, and business support of our key enabling technologies. This role will require 4 days per week onsite at one of our Corporate locations in Sleepy Hollow, NY or Dublin, IRE. This is not available for fully remote / hybrid work. As a Sr. Manager, HR Technology a typical day may include: Partner closely with our HR COE and HRBP leadership to understand their challenges, business priorities, and associated prioritization. Provide strategic guidance and ensure alignment with organizational goals. Armed with this knowledge, oversee the development of clear and concise business and functional design requirements. Lead the creation of a prioritized backlog and ensure smooth transition to IT Product Managers for solution design and delivery. Provide oversight for, as well as conduct user acceptance testing and ensure alignment with business needs. Partner with COE resources to ensure change/comms/training materials are updated in line with process changes. Drive successful business outcomes by applying advanced business analyst capabilities (strategic thinking, agile working, process design expertise, data analysis, critical thinking, problem solving, stakeholder communication, etc.) throughout project lifecycles. Identify and implement innovative tools to support workforce needs or extend the use of existing tools into new locations or functional areas. Oversee and provide end-user support for Workday (Core HCM & Security) and ensure processes support the resolution of queries in a customer-centric manner. Provide strategic insights from ticket management trends to inform training/communication strategies and continuous improvement demands. Manage the escalation process to Technology partners for any technical issues/incidents. Provide governance and ensure escalations are resolved in a timely and effective manner. Establish and maintain strong relationships with stakeholders (globally and locally). Develop an intimate understanding of their key strategic and operational demands, translating these into actionable plans and requirements. Oversee the end-to-end journey of these demands and projects from idea to operational delivery to ensure key stakeholders are kept informed of progress. Partner with IT Product Managers, to ensure business and functional requirements are documented and understood. Ensure prioritized demands are delivered within agreed timelines and to a level of quality expected by the business. Stay abreast of the latest industry trends and thought leadership, to ensure that we are keeping an eye on the future and art of the possible with regards to all roadmap planning and delivery. This role may be for you if you have: Proven ability to manage multiple projects delivered on time with high customer and team satisfaction. Strong data analytics skills to distill complex details into actionable insights and recommendations. Comfortable working with ambiguity, supporting diverse leaders with diverse needs, and driving alignment in a unified direction. Effective communicator with credibility and empathy, engaging with stakeholders and driving collaboration. Intellectual curiosity to optimize business requirements and identify innovative solutions to complex problems. To be considered for this role you are required to posses a Bachelor's or Master's degree in a related field with 8+ years of experience in HR, focusing on WorkDay Core HR and Security processes/technology in a global environment. Extensive hands-on experience with Workday HCM and Security, translating business demands into high-quality requirements. 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) $132,400.00 - $216,000.00
