38 pharmaceutical jobs found

Career Category Quality Job Description QA Specialist, Deviations Role Overview The QA Specialist, Deviations provides Quality Assurance oversight and subject matter expertise for deviations, investigations, CAPAs, and change controls. Working closely with Manufacturing, Engineering, Validation, Quality Control, and Supply Chain, the role ensures quality investigations are managed effectively and in compliance with GMP requirements, regulatory expectations, and Amgen standards. Key Responsibilities Provide QA oversight of deviations, investigations, CAPAs, and change controls, ensuring timely and compliant execution. Review and approve quality records, ensuring appropriate scope, root cause analysis, risk assessment, and corrective actions. Represent QA at Deviation Review Boards, Change Control Boards, and other cross-functional forums. Support complex investigations and provide quality guidance on compliance and operational issues. Monitor quality system...

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...

Job Description The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality. In this role, a typical day might include the following: Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes Demonstrate company values by demonstrating excellence, competence,...

As an integral part of a study, the statistical programmer provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following: Assist in providing mentorship in implementing and driving the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Design and test program logic, coding programs, program documentation and preparation of programs. Coordinates projects crafted to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment. Support and/or lead programmer for...

The Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s). They will work with management and study team, plan and own the implementation and execution of programming project standard to support from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests. Be responsible for owning the programming aspect of a project and working with internal partnering functions, partners, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality. In this role, a typical day might include the following: Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming results in assigned projects and areas. Coordinate programming documentations and specifications for multiple studies following...

Preclinical Operations (PCO) is seeking a dynamic Associate Manager, Preclinical Operations  to join the team.  Using program management knowledge and experience in the drug development industry, the successful candidate would provide operational and Project Management support to Preclinical Development (PCD) and Drug Safety & Pharmacometrics (DSP) for multiple assigned projects .  The successful candidate would also provide guidance and input to cross-functional project teams to enable projects to drive to completion. This role has a 3-day onsite minimum requirement in Tarrytown, NY. Relocation can be provided. A typical day as an Associate Manager looks like: Facilitates development and alignment of  integrated PCD/DSP cross-functional project deliverables, plans, timelines and  resources,to align with the overall project plan throughout the project lifecycle from preclinical through commercialization. Ensures effective execution of project plan to...

The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality. In this role, a typical day might include the following: Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect,...

The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality. In this role, a typical day might include the following: Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect,...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality. In this role, a typical day might include the following: Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Develop and maintain programming documentations and specifications following programming standards and processes Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect,...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks,...

A senior statistical programmer provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following: The incumbent assists in providing guidance in implementing and executing the programming and project standards. The evaluation and development of study  requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Manager Statistical Programming provides timely support to the study team on all programming matters according to the project strategies. Provide project leadership and programming support for processing data from clinical studies. Provides guidance in implementing and performing the programming and project standards. Lead the programming aspect of a project, both internally or CROs, for all programming results from the single study through to regulatory approval, product launch, data monitoring boards and annual reports. In this role, a typical day might include the following: Develop an expertise within a therapeutic area or standard tool. Work with minimal direction to perform, coordinate and be responsible for the preparation, execution, reporting and documentation of a project. Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements using Regeneron tools and methodologies and current...

The Manager, Scientific Writing Operations supports and works closely with the Scientific Writing Operations Lead to support and assist with SW resource (capacity) management and development of the outsourcing strategy. In this exciting role, you will work with outsourcing vendors to facilitate contract development and implementation, while also onboarding/off-boarding activities while also supervising external consultants at times. A Typical Day in the Role Might Look Like: Screens and supervises external consultants Assists with contractor/vendor selection, initiation, and implementation of collaborations  Serves as point of contact with vendors for contracting and financial aspects of external engagements  Identifies training needs, monitors adherence to document processes, and provides support for external personnel Collaborates with Procurement, Finance, and Business Operations to help manage contracting, budgeting and spending for Scientific Writing Manages...

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 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...