We are currently searching for a skilled professional to join a well-known client’s team as a Program Manager, in Princeton, NJ. The Program Manager will act as a central contact for information on assigned programs and manage activities to develop and commercialize programs. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Manages and tracks progress for two or more development programs from early clinical development through product launch and full life cycle management, identifying and tracking both cross-project and cross-functional issues, as well as scope, timeline, and budget issues
- Works proactively with manager and the project team to achieve timely resolution of issues in order to meet approved program objectives
- Supports cross-functional project teams in the implementation of the strategic and operational plans, ensuring smooth transitions between development milestones from early clinical development through product launch and full cycle management
- Responsible for ensuring timely, accurate and comprehensive project and program information is available to senior management and the wider organization
- Facilitates the review of development projects with Senior Management, makes recommendations for action, and ensures appropriate follow-up by management to meet approved program/project objectives
- Works with the relevant functional areas/teams to lead the development of quality global development and commercialization plans which integrate the development strategy and project plan (inclusive of timelines, milestones, interdependencies, issues, risks and actions)
- Responsible for maintenance of the project actions, decisions, risks, (ADR) log for project team interactions and maintains project schedules
- Responsible for developing and maintaining good relationships with other functions such that it will foster positive interactions and ultimately support achieving desired project outcomes
- Responsible for supporting departmental and corporate initiatives to drive process improvements if needed
- Support alliance management activities based on program requirements
- Ensure that concurrence between the team and line management is achieved for program objectives and objectives are met to attain the organization’s goals of timely and quality-focused development of new therapies and life-cycle extensions within the portfolio
- Work with senior project management staff and teams to create the development strategy, establish objectives, and monitor team progress
- Make recommendations regarding project objectives, resource requirements, and scientific direction to line and senior management
- Minimum of 5 years of project or program management experience in the pharmaceutical industry
- Knowledge of clinical operations and the regulatory process, as well as a thorough understanding of each functional area’s role and contribution to the drug development process
- Experience assisting teams in preparation for regulatory interactions; regulatory submission experience preferred but not required
- Extensive Clinical Experience Required
- Regulatory experience a plus
- Experience working with global teams is a plus
- Extensive experience using Microsoft Project required
- Experience with Microsoft 365 a plus
- Solid understanding of how IT solutions are integrated into the healthcare/pharmaceutical business to drive value
- Experience with e-Trials (i.e., e-Consent, e-Scanning, e-TMF, e-Source, e-Surveillance)
- Understanding of an IT/technology systems lifecycle, implementation requirements and associated terminology
- Understanding of reporting and analytics requirements and report generation
- Solid understanding of global regulatory submission types and requirements
- Understanding of regulatory filing processes
- In-depth knowledge of business functions and cross group dependencies/ relationships as related to regulatory dossiers
- Experience facilitating functional group interactions in the development of relevant information to complete a regulatory submission
- Experience managing complex regulatory projects for global filings and experience working with regulatory agencies, e.g., FDA and DEA, and state health boards a plus
- Bachelor’s Degree
- Master’s degree with at least 3 years of global drug development experience preferred
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.