Program Management Consultant

Princeton, NJ

Contract

apply now

OVERVIEW

Our client is revolutionizing the pharmaceutical industry and is looking to hire a highly skilled professional for the role of Program Management Consultant in Princeton, New Jersey. This person must be Regulatory-focused with experience in the clinical space and know the drug development process well. The company has one of the strongest reputations in the clinical business to add to your career and resume. 

RESPONSIBILITIES

  • Manages and tracks progress for two or more development programs from early clinical development through product launch and full life cycle management
  • Identifies and tracks both cross-project and cross-functional issues, scope, timeline, and budget issues 
  • Facilitates the review of development projects with Senior Management
  • Makes recommendations for action, and ensures appropriate follow-up by management 
  • Leads the development of quality global development and commercialization plans 
  • Responsible for maintenance of project actions, decisions, risks, (ADR) log for project team interactions and maintains project schedules 
  • Responsible for developing and maintaining good relationships with other functions to foster positive interactions and support desired project outcomes
  • Responsible for supporting departmental and corporate initiatives to drive process improvements 
  • Supports alliance management activities based on program requirements

EXPERIENCE 

  • A minimum of 5 years of project or program management experience in the pharmaceutical industry (Bachelor’s Degree)
  • Minimum of 3 years of global drug development experience preferred (Master’s Degree)
  • Solid understanding of global regulatory submission types and requirements
  • Understanding of regulatory filing processes 
  • In-depth knowledge of business functions and cross group dependencies and 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
  • Extensive experience using Microsoft Project required; experience with Microsoft 365 a plus

EDUCATION

  • Bachelor’s Degree required
  • Master’s Degree desirable

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.

847-267-1176