178 pharmaceutical jobs found in Bernards, NJ

Inizio Engage is building a nationwide team of field based Pharmaceutical Sales Representatives. This is an excellent entry-level role in the healthcare and pharmaceutical industries. The team will be dedicated to providing services to Inizio’s client, Pfizer.    The main objective of the Field Pharmaceutical Sales Representatives position is to increase awareness of high/at-risk patient type for COVID-19.    This is a Field Contracted Team with the ability to create awareness on high/at-risk patients for COVID-19 with targeted HCPs along with urgent cares and retail pharmacies as directed. This role will report to the Area Business Manager.    Your role will involve:     Provide P1 support to physicians about COVID-19 risk factors, disease progression, and treatment options   Educating identified targets to ensure customer preparedness on patient identification as above.       Build working relationships with customers through regular calls and ongoing contact...

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 has a 3-day onsite minimum requirement at either Basking Ridge, NJ or Armonk, NY. 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...

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...

This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization.  This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization’s GxP framework.   In this role, a typical day might include: Project Management and leadership in the delivery of regulatory intelligence research services and information Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders...

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 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 Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Sr. Manager reports to the Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the following: Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam Develops/maintains...

The Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Sr. Manager reports to the Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the following: Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam Develops/maintains...

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities within...

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 Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities. In this role, a typical day might include the following: Provide interpretation of regulatory authorities’ feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval. Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and...

The Manager, Vendor & Relationship Management (VRM) provides support to the operational requirements for which VRM has accountability to ensure optimal functionality and business operations within VRM along with support of the overall delivery of the Vendor Engagement life cycle.    This position will have key interactions with partnering functions within REGN as well as with external partners. ​Leads, on behalf VRM, the document collection and analysis of Governance and Oversight Compliance. A Typical Day Might Look Like this: Manage and document the tiering of Global Development Vendors in collaboration with VRM staff and relevant functions Measure and manage the application of Partnership Effectiveness framework and behaviors across Global Development Support generation and continuous improvement of VRM metrics, including additional support needed to each Segment on applicable Vendor/segment specific dashboards Leads and oversees the creation,...

The Associate Director, Vendor Management, is responsible for assessing, onboarding, and overseeing the health and performance of vendors involved in clinical trial execution. This role ensures that vendors meet the necessary qualifications and compliance standards, manage relationships, and oversee delivery to time, cost, and quality. This position is capable of leadership and oversight of vendor segments, and of the technical aspects such as quality, compliance, business continuity, and inspection readiness. This position is expected to have the ability to execute a variety of roles to meet the expectations of effective relationship management and driving compliance and high-quality delivery.   Relationship Management Oversee the performance and health of vendors within assigned segment to ensure deliver to plan – time, budget quality. Develop/enhance vendor performance scorecards that drives identification of mitigations/contingencies against performance...