Program Manager, Regulatory Systems Jobs in Boston MA | Life Sciences,Project/Program Management Job Recruiters

Program Manager, Regulatory Systems

Boston, MA | Work from home flexibility

Posted: 09/23/23 Category: Life Sciences, Project/Program Management Job Number: 21557

Job Description

Position: Project Manager, Pharma
Location: Remote
Job Type: Contract
Duration: 1 year + (will be long term)

We seek a Project Manager who can partner with our scientific and technical/data teams to enhance and drive the acceleration of the drug discovery process.
  • This role is responsible for managing projects for all core medicine development activities from first in human trials to medical affairs and education: clinical pharmacology, modeling and simulation, clinical operations, clinical data management, biostatistics, medical monitoring, clinical development, medical writing as well a drug development support activities for regulatory affairs, global patient safety and quality.
  • Tight alignment with the clinical, regulatory and medical affairs leadership and teams.
  • Expertise in designing, building and managing fast-paced clinical, medical affairs, medicine development and analytics environments
  • Would consider a program manager or PM
  • This person will directly assist w implementation, budget, manage vendor effectively, manage business requirements, risk, etc. 
The Project Manager is a role within the Technology Program Management Office reporting directly to the Senior Director, Portfolio Manager, with dotted line matrixed reporting to the Senior Director. 
Building on the current strategy, the team will design, develop and deliver an implementation program for projects.  The Project Manager will be charged with hands-on management of all PMO activities and ensuring accurate status reporting across all workstreams and driving the project outcomes.
The Project Manager is required to have relevant PMO-related experience specifically in Clinical Data Management within the biopharmaceutical industry. This experience will be critical in understanding both the process challenges and the technology being implemented, which will help the Project Manager facilitate successful delivery outcomes. 
The Project Manager will work closely with the Director and ensure that the projects are in alignment with other inter-dependent projects, programs and stakeholders.
The Project Manager will be responsible for:
  • Program and Workstream Governance
  • Scope Management
  • Schedule Management
  • Resource Management
  • Financial Management
  • Risk and Issue Management (including cross-functional impact assessment/mitigation)
  • Dependency Management (both within the program and externally)
  • Integration Management
  • Stakeholder Management
  • Communications and Change Management
  • Business Adoption and Acceptance / Client Satisfaction
The Project Manager should expect to be heavily involved in presenting and monitoring status, anticipating challenges, unblocking issues, managing dependencies and providing business sponsor and stakeholder transparency for the program through accurate and timely management reporting.  The Project Manager may also be responsible for collaboration with project managers from external consulting teams to ensure successful joint outcomes and accurate management reporting.

Required Knowledge, Skills and Experience:
Knowledge and Experience
  • A minimum of 10 years of experience in Project Management
  • Demonstrated proficiency in managing large-scale, complex projects
  • Training and experience in Agile practices
  • Experience working specifically on Clinical Data Management projects within the biopharmaceutical industry
  • Demonstrated leadership presence and drive
  • Excellent presentation skills and ability to clearly and succinctly express ideas
  • Experience facilitating project meetings and effectively and respectfully holding team members accountable for status, deliverables and the timely escalation of blockers
  • Unfailing commitment to representing project status in an accurate and timely manner, weekly or in near real time when changes occur
  • Successful track record of managing collaborative projects with vendors and packaged software
  • Exemplify a highly collaborative mindset and actively facilitate team communication
  • Build strong relationships with peers and colleagues across the Technology organization, and with key business clients
  • Actively anticipate, track and plan for risks and issues, dependencies, resourcing and contingencies
  • Communicate status, risks and issues in a direct and timely manner
  • Escalate issues in a manner that is effective and direct
  • Demonstrate an analytical, objective, and strategic mindset and a drive to learn new technologies
  • Analyze processes and systems, identifying potential for change
  • Possess an understanding of technology solutions implemented in the past
  • Excellent communication skills, both verbal and written
  • Experience practicing project feature prioritization and backlog grooming methods
  • Experience with Project and Portfolio Management (PPM) tools and reports
  • Demonstrate ability to accurately track and forecast financials and provide accrual information to Finance
  • Understanding of the principles of finance and cost benefit analysis (e.g., capitalized, amortized and expensed costs, opportunity costs, soft and hard dollar benefits, payback, ROI, ROE, NPV, etc.) 
Preferred Knowledge, Skills and Experience:
  • Biopharmaceutical or biotechnology experience
  • Experience with high-growth stage companies
  • Agile CSM, PSM or similar certification and hands-on experience
  • PMP or Prince2 certification

Queen Consulting Group is an equal opportunity employer. Our goal is to promote an environment that helps our employees and clients appreciate the benefits that diversity provides.

Meet Your Recruiter

Chelsea Calvanese
Recruiting Delivery Lead

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs: