Project Manager Product Development at Noven Pharmaceuticals

Jersey City, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Apr, 26

Salary

0.0

Posted On

27 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Communication, Analytical Skills, Interpersonal Skills, Organizational Skills, Regulatory Compliance, Cross-Functional Collaboration, Risk Management, Problem Solving, GxP Principles, Drug Development Lifecycle, Decision Making, Team Alignment, Influence, Collaboration, Documentation

Industry

Pharmaceutical Manufacturing

Description

Overview We are seeking a proactive and detail-driven Project Manager to join our Program Management team. In this role, you’ll partner closely with cross-functional teams including R&D, Analytical, CMC, Clinical, Regulatory, and Quality to keep projects moving and deliver results that matter. Reporting directly to the Associate Director of Program Management, who owns the overall program timelines and strategic direction, the Project Manager will focus on the tactical execution of project elements. The ideal candidate will have strong organizational and communication skills, experience working in a regulated environment, and the ability to proactively manage complex tasks and dependencies. The ideal candidate thrives in a fast-paced and team environment, excels at managing dependencies across R&D, regulatory and clinical teams, and is committed to driving operational excellence in compliance with industry regulations such as FDA and ICH guidelines. Responsibilities As a Project Manager, responsible for overall day-to-day execution of assigned workstreams for development programs. Drive operational execution of assigned workstreams to ensure deliverables are achieved in alignment with defined scope, timelines and program objectives. Support the Associate Director in coordinating project meetings, preparing agendas, capturing decisions and driving action-item closure. Track progress against defined project deliverables and monitor any issues that may have impact on the timelines for project deliverables. Coordinate cross-functional activities and maintain clear documentation of decisions, risks, and action items. Report project progress, gaps and critical issues to Associate Director of Program Management to facilitate seamless execution. Identify potential risks or bottlenecks and escalate to the Associate Director for resolution and decision-making. Track and monitor progress of program specific deliverables and ensure they are completed within schedule and in compliance with company standards. Ensure consistent and transparent information flow between functional teams and program leadership. Ensure all activities adhere to pharmaceutical best practices, including GxP compliance and data integrity standards. Qualifications Key Competencies: Strong communication, analytical and interpersonal skills to manage cross-functional relationships and external partners effectively. Demonstrated judgement in balancing competing priorities and escalating issues appropriately. Proven track record of fostering team alignment and delivering results through influence and collaboration. Successful in managing cross-functional teams and driving projects to completion within defined scope and timelines. Communication: Excellent verbal and written communication skills. Ability to identify dependencies and potential misalignments. Strong collaborative and communication style to influence without authority and maintain strong working relationships across functions. Education / Experience: Bachelor’s or Master’s degree in Life Sciences, Pharmacy or related field (advanced degree preferred). 5 years of minimum experience in pharmaceutical or biotechnology project management operations with exposure to R&D or clinical function. Solid understanding of drug development lifecycle from early stage though clinical and regulatory approval. Proficiency in project management tools and systems (e.g., MS Project, Smartsheet, or equivalent). Working knowledge of GxP principles and regulated environments. Judgment / Decision Making: Recognizes when to act independently with limited supervision. Strong analytical and critical thinking skills to mitigate complex situations. Ensures all actions are aligned with GxP, corporate policies, and regulatory expectations. Financial Responsibility: Errors in judgment or failure to achieve objectives would typically result in noticeable program delays and considerable expenditure of resources to rectify. Responsibilities for Contacts: Frequent contact with functional heads and other members across the Product Development organization. Work Environment: Majority of time spent in office environment, operating computer. Physical Demands: Visual acuity and manual dexterity required to operate computer and proofread documents

Responsibilities

The Project Manager is responsible for the overall day-to-day execution of assigned workstreams for development programs, ensuring deliverables align with defined scope and timelines. They will also track progress, coordinate cross-functional activities, and report on project status to facilitate seamless execution.