4 jobs found in Bernards, NJ

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...

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 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 Senior Statistical Programmer provides support to the lead programmer and study team on all programming activities according to the study requirements and the timelines. This role contributes to studies in various therapeutical areas and all clinical trial phases. The incumbent implements and executes the programming and project standard under minimal supervision of the lead programmer and manager to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. Maintains programming documentations such as study tracker, code, logs, and outputs in a regulated environment.   In this role, a typical day might include the following:    Provide programming support within multiple studies/projects in various study activities with timely and high-quality programming deliverables in assigned tasks and projects   Demonstrate company values by demonstrating excellence, competence,...