31 pharmaceutical jobs found

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Position Summary   We are  seeking  an experienced and  Swissmedic -recognized  Fachtechnisch   verantwortliche  Person ( FvP ) to support the establishment of a local pharmaceutical quality system in Switzerland and lead the company’s efforts to obtain and  maintain...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration....

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...

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 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...

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...

In this role you will be responsible for fostering a culture of data governance (DG) within the site by ensu r ing compliance with Data Governance policies ; designing and delivering relevant training ; and monitoring Data Governance practices. The role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in the site culture.   In this role, a typical day might include the following: Work ing in conjunction with the Global DG (Policy & Programs) t eam to d esign and deliver c ontinuous DG Training in line with current and evolving required DG knowledge, skills and awareness needs . This includes:   Designing and developing comprehensive training programs focused on DG , compliance with regulations, and best practices for bio- pharmaceutical manufacturing   Conduct training needs assessments to identify training gaps and areas...

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s). Your role will play a fundamental par t in safeguarding the quality and reliability of the organisation’s data which is essential for informed decision making and regulatory compliance. In this role, a typical day might include the following: Successful building, leading and managing of the site Data Operations &  Engagement, C ulture & Monitoring (ECM) t eam Successful delivery/implementation of site data governance (DG) responsibilities and standards   Responsible for successful stakeholder engagement and management across the site   Responsible for establishing a successful relationship with the global Governance Team (Policies & Programs) so a clear feedback loop is established     Responsible for the...

In this role you will play a pivotal part in ensuring that Regeneron’s Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will be r esponsible for providing specialised knowledge and expertise in the design of ( DG) frameworks, policies and procedures that are aligned with regulatory requirements and industry standards.   In this role, a typical day might include the following: Assessing current and evolving regulatory guidance and industrial intelligence in relation to IOPS business practices   Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices   Technical writing, research and related editing activities , ensuring accuracy and consistency of documentation and that the appropriate approvals are received   Generating and...

As a key member of the Global Corporate Compliance Operations team, you will support business operations and lead Regeneron’s compliance-related activities in the UK, 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 UK operations. Design and deliver comprehensive compliance training programs for employees and third parties, ensuring a deep understanding of compliance principles and industry codes. Provide proactive risk management and compliance support, collaborating with business leaders...

We are currently looking to fill a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron’s Data Governance systems and practices meet the highest standards of regulatory & industry compliance. The post-holder is responsible for providing specialized knowledge and expertise in the design of Data Governance (DG) frameworks, policies & procedures that are aligned with regulatory requirements and industry standards.     In this role, a typical day might include the following:   Assess current and evolving regulatory guidance & industrial intelligence in relation to IOPS business practices.   Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices . Technical writing, research, and related editing activities, ensuring accuracy and consistency of documentation and that the...

This leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track record for driving success. The post-holder will set and implement a strategic vision for Regeneron’s data maturity roadmap including policies & procedures.   They will lead the required change management program to enable the creation and embedding of a sustainable data quality culture across the organization.   They will also be accountable for the Regeneron Industrial Operations and Product Supply (IOPS) DG program & serve as the global leader and subject matter expert on DG practices. In this role, a typical day might include the following: The creation & delivery of IOPS’ DG Program (Strategy,...