6 jobs found in New Brunswick, NJ

Account Director, Medical Communications Overview eNova, an IQVIA business, is a next-generation medical communications agency. Our mission is to transform medical communications by connecting HCPs and stakeholders across the healthcare ecosystem with content that advances science and medicine. We are currently seeking an experienced Account Director to join our team in support of both new and existing client relationships.The Account Director is responsible for the management and delivery of engagements within their portfolio, and is a key relationship driver for our client accounts. Essential Functions Business Growth Partner with clients to identify traditional and innovative solutions that drive brand growth which translate to organic growth for eNOVA, actively participate in strategic brand and tactical planning and contribute to the development of tactical plans Client Management Serve as primary liaison to the client and agency team for all...

The Process & Procedures (P&P) Lead, Director is responsible for the end-to-end procedure development lifecycle. The Director role is responsible for collective multiple partner groups, understanding interdependencies and overall efficiencies through process optimization. We require the Director to act as a thought partner to support process effectiveness related to compliance and standard processes. We expect a great level of business insight, critical and thinking to support management of sophisticated issues that demand interaction with senior leadership in a highly matrixed environment. Process/Procedure development includes interpreting global and country specific functional business regulatory requirements and industry standards to deliver a portfolio of controlled procedural documents. The role will provide procedural expertise and work across multiple functions in Global Development to identify cross-functional dependencies and ensure project timelines are met. We...

This is a hybrid position on-site 3 non-consecutive days in Armonk, NY or Basking Ridge, NJ. The Director, Strategy Planning & Operations will partner with the functional VP(s)/Functional Head(s) and their Senior Leadership Teams (SLTs) to lead the development and execution of functional & corporate-level strategic initiatives, setting objectives and goals, resource & finance management, cross-functional alignment, issue identification, mitigation and resolution, while driving operational efficiencies. This role enables the vision and mission of an impactful, strategic, and quality-focused function that is well-aligned cross functionally, internal and external to Development Operations, Portfolio Management, and Biostatistics & Data Management (DO, PM & BDM) and Global Development (GD). This role collaborates with other GD Strategy Planning and Operations staff and functional SLTs, to drive value and strategic evolution of the specified organization. This...

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 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 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...