41 Legal jobs

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.  Owens & Minor teammate benefits include: Medical, dental, and vision insurance, available on first working day 401(k), eligibility after one year of service Employee stock purchase plan Tuition reimbursement On Site 3 days a week at various hospital locations. RESPONSIBILITIES Develops and maintains strong, account-specific operational processes and performance with the customer. Performs duties on-site with the customer, reacting in a timely manner to customer information and requests. Manages and ensures contract...

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.  Owens & Minor teammate benefits include: Medical, dental, and vision insurance, available on first working day 401(k), eligibility after one year of service Employee stock purchase plan Tuition reimbursement RESPONSIBILITIES Develops and maintains strong, account-specific operational processes and performance with the customer. Performs duties on-site with the customer, reacting in a timely manner to customer information and requests. Manages and ensures contract compliance to all agreed terms and conditions. Collaborates...

Job Summary Manage, produce and communicate Corporate Sales requests from Sales Management and for the department concerning Corporate Contracting efforts.  Responsibilities include:  contract drafting, amendments/addendums, contract loading in SAP, effective data management within SAP, and answering general contract questions from sales representatives, sales management and internal Medline colleagues.   Job Description Responsibilities: Create contract proposals, amendments/addendums as requested from sales field members.  Ensure proposals are reviewed and furnished with the utmost accuracy in accordance to the original request. Enter contract requests received in master log to track all activities within the contracting department. This would include open/completed field requests. Enter all deal specifics of the contract into SAP.  Communicate contract details to other departments with a cover communication to a predetermined contact list within established...

Our Regeneron Global Procurement Team is looking for a Manager, Global Procurement supporting the CMO (Contract Manufacturing Organization) space with experience in end-to-end procurement strategies, processes, and global category execution. This Manager will be a part of an amazing team reporting to the Director of Global Procurement - Direct organization. Do you want to be part of something great? Join us! Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron's unique ability to translate science repeatedly and consistently into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron's laboratories. A typical day might include the following: Leading and working with others to solve issues of diverse scope and provide analysis...

Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in a compliant manner. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. As Director of GMP Compliance & Inspections a typical day may include, but is not limited to, the following:   Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems Leading proactive evaluation and education of site GMP compliance against current and emerging...

Within this role you will support the Process Sciences laboratory operations by supporting adherence to site policies and procedures associated with but not limited to good documentation practices, data integrity considerations, equipment and vendor maintenance and PS study execution, recording and reporting. As a Compliance Specialist within Process Sciences, a typical day might include, but is not limited to, the following:   Ensuring oversight and support for PS laboratory operations comply with site data integrity policies and procedures. participating in ATRAs, audit trails reviews, data recording, storage, and verification Maintaining laboratory records in accordance with site procedures is essential. Types of records include paper and electronic lab notebooks, laboratory logbooks, equipment maintenance records, and laboratory study protocols and reports Completing quality records such as deviations, CAPAs, and change controls with support and oversight...

Regeneron Pharmaceuticals Inc. is seeking a Director Patent Attorney to develop global IP strategies around key molecules, platforms and other technologies to ensure Regeneron’s long-term competitive advantage. This unique in-house opportunity will be part of a high-performing team of IP practitioners devoted to protecting Regeneron’s innovations derived from Regeneron’s cutting-edge science and numerous collaborations, including over 75 collaboration agreements executed in the past 5 years. The patent attorney will enable key synergistic collaborations and acquisitions by providing IP transactional and due diligence support in close partnership with colleagues in the R&D, clinical, regulatory, legal, business and alliance management departments at Regeneron. This role will also advise on emerging legal issues, including monitoring and reviewing case law and legislative developments, and is expected to contribute to administrative and legal projects intended to develop an IP...

Director, Global Compliance Operations (France) As a key member of the Global Corporate Compliance Operations team, you will support business operations and lead Regeneron’s compliance-related activities in France, with the potential to provide ad hoc support to other European markets if needed. You will work closely with other compliance leaders to support monitoring, conduct internal investigations, develop policies, provide training, facilitate communications, and ensure transparency, all aimed at further developing and implementing Regeneron’s compliance program. A typical day may include: Developing and refining compliance policies that integrate appropriate healthcare, corporate, and other compliance controls to guide Regeneron’s French operations. Designing and delivering comprehensive compliance training programs for employees and third parties, ensuring a deep understanding of compliance principles and industry codes. Providing proactive risk management and...

This Senior Director, Corporate Compliance role is a strategic and dynamic role serving as a Compliance Navigator/Advisor to various areas of the business, with a particular focus on supporting Regeneron’s Global Immunology team. This individual will conduct day-to-day risk assessment and management to help support the vision for Compliance at Regeneron, by embedding ethical and risk-informed decision-making into the organization. This role is expected to be the key liaison and primary point of contact for Compliance-related topics to assigned areas of the business, including headquarters and field-based Commercial and Medical Affairs teams. This individual will integrate practical compliance best practices within business processes. In addition, this individual will synthesize learnings from partnerships across business functions to develop innovative and agile methods to better identify Compliance risks and enhance monitoring opportunities. This individual will be expected to...

In this role, you will be at the forefront of developing and implementing innovative contract models tailored to our diversified oncology portfolio. You will build and maintain long-term business relationships with key stakeholders, specifically in the hospital, GPO, and wholesale segment, analyze market trends, and provide strategic input to drive our business forward. A typical day might include the following: Negotiation and conclusion of contracts primarily with hospitals, purchasing groups (GPO), and regional and national health insurance funds across Germany. Developing and implementing innovative contract models tailored to our oncology portfolio. Establishing and maintaining long-term business relationships with key stakeholders in the healthcare sector. Analysis and evaluation of market trends and competitive activities to optimize negotiation strategies. Development of education and training concepts for the internal Commercial team as well as external...

The successful candidate will manage and support the external testing activities within the Quality Control group in support of the company’s quality program. A typical day might include, but is not limited to, the following: Organizing and scheduling external testing to support product release/stability testing under cGMP Managing external data review per production schedule and stability program Performing the single point of contact role with contract laboratory facilities Evaluating and monitoring the performance of the contract labs Coordinating investigation activities at contract laboratories to ensure thorough technical content and compliant documentation Communicating and soliciting input from Regeneron SME’s and Quality Assurance Coordinating the issuance and approval of Quality Agreements with contract labs Authoring Master service Agreements, as necessary Participating in GMP audits to the contract labs Coordinating and leading quarterly meetings...

The HCP Contracting Manager will facilitate the contracting process for oncology international activities for Regeneron. This role encompasses overseeing the end to end process of HCP contracting and sponsorship activities.   what a typical day might look like: Oversee the complete contracting process with members of the healthcare community and sponsorships across multiple geographies. Serve as the primary point of contact for guidance and support on contracting processes. Provide training on processes and develop and maintain resources, web pages, training materials, and quick reference guides. Manage relationships with key internal stakeholders, including Medical Teams, Compliance Officers, Legal Counsel, Finance, and Commercial Operations. Stay informed about company policies, procedures, and government regulations related to HCP Contracting and Sponsorships. Proactively develop and provide timely resolution to issues Participate in...

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

The Sourcing Specialist will be responsible to support assigned categories and is a proven collaborator who can work with cross functional teams across Regeneron, locally, regionally and internationally. Essential Duties and Responsibilities include, but are not limited to, the following: Being accountable for supporting the definition and implementation of the assigned categories strategy to serve global and regional business needs as assigned. Working closely with stakeholders to support discussions related to the assigned categories and aligns category priorities with Procurement management and stakeholders. Supporting negotiations, supplier management activities, and stakeholder engagement activities for the Categories as assigned. Taking direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Supporting Global Procurement by participating in organizational decisions in the...

Regeneron is seeking a Manager, Global Patient Safety Quality and Compliance role, reporting into the Associate Director of Quality and Compliance (Q&C). This position is responsible for performing quality review tasks related to ICSRs and other GPS deliverables including conducting quality control review of individual case safety reports. This position will also provide support in other tasks for Q&C, as needed. In this role, a typical day might include: Conducting regular quality control review of ICSRs based on established documented procedures Conducting quality control reviews of Global Patient Safety deliverables including Safety Agreements and Safety Management Plans Generating and reviewing metrics related to quality control of ICSRs Performs regular trending of quality results to identify potential trends This role might be for you if can: Effectively manage workload to ensure overall compliance with GPS standards...

The Senior Manager, Global Procurement – Supplier Quality Compliance will be responsible for leading a small team of Global Procurement Compliance professionals that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. A typical day may include: Tracks progress on all Global Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates Interfaces regularly with Quality Assurance and...

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. *This is an onsite position located in Rensselaer, NY* As a Facilities Compliance Specialist, a typical day might include the following: Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner...

The Medical Affairs HCP Engagement Temp will provide project management support for international markets on HCP Engagements and sponsorships. This position reports to the Sr. Manager of Medical Affairs Business Operations. What a typical day may look like; Coordinate the complete contracting process for members of the healthcare community within international countries. Serve as the primary point of contact for medical teams seeking mentorship and support on contracting processes related to HCP engagements and sponsorships. Provide training on processes to relevant teams and collaborate with the Sr. Manager to develop and maintain resources, web pages, training materials, and quick reference guides. Stay informed about company policies, procedures, and government regulations related to HCP engagements and sponsorships.  Conducting regular reviews and supporting internal audits. Handle relationships with key internal stakeholders, including...

This is a leadership role providing Quality and Compliance oversight of site operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Associate Manager Quality Compliance , a typical day might include, but is not limited to, the following:   Ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities and materials management Overseeing site quality systems including but not limited to; Deviations, CAPA, Change Control, Audits (Internal and External) and Customer Complaints Being responsible for review and approval of the following types of documents, relating to area functions: failure investigations, change control documents, corrective/preventative action documents, standard...

Within this role you will be responsible for coordination and completion of manufacturing deviations and change controls.   As an Associate / Compliance Specialist a typical day might include, but is not limited to, the following:   ·          Coordinating and documenting of manufacturing quality events including but not limited to deviations and change control’s ·          Coordinating cross functional teams during Change Control/Deviation events and align team on approach forward ·          Utilizing problem solving methodologies such as fishbone, 5 Whys to establish root cause of deviations ·          Working closely with Manufacturing Managers to review and evaluate quality event information ·          Assessing event for impact to SISPQ, conduct risk assessments and initiating appropriate corrective actions to prevent recurrence ·          Coordinating of internal reviews of investigational reports ·...