Project Director

3 weeks ago

Reston, Virginia, United States Intellectt Inc Full time
Project Manager - Pharmaceutical Industry

Intellectt Inc is seeking a highly skilled Project Manager to lead cross-functional teams in the planning, execution, and completion of drug development and pharmaceutical-related projects. The ideal candidate will have experience in the pharmaceutical industry, strong project management skills, and a thorough understanding of regulatory and compliance requirements.

Key Responsibilities:
  • Develop comprehensive project plans, including timelines, budgets, and resource allocation.
  • Coordinate project activities and monitor progress against the plan.
  • Identify and mitigate project risks and issues.
  • Lead cross-functional teams, including R&D, clinical operations, regulatory affairs, quality assurance, and manufacturing teams.
  • Facilitate communication between team members and stakeholders to ensure alignment.
  • Monitor project budgets and expenditures, ensuring the project remains within financial constraints.
  • Coordinate resource allocation, ensuring necessary personnel and materials are available.
  • Ensure that projects comply with all relevant regulatory requirements, including FDA, EMA, and other international guidelines.
  • Coordinate regulatory submissions, including IND (Investigational New Drug), NDA (New Drug Application), and other relevant filings.
  • Ensure documentation is complete and accurate for regulatory audits.
  • Oversee the planning and execution of clinical trials, including site selection, patient recruitment, data collection, and monitoring.
  • Collaborate with clinical teams to ensure trial milestones are met.
  • Provide regular updates to stakeholders on project status, risks, and issues.
  • Prepare and present reports to senior management, ensuring they are informed about project progress and potential obstacles.
  • Manage external vendors and contract research organizations (CROs), as needed.
  • Identify areas for process improvement and implement best practices in project management.
  • Stay current with industry trends, technologies, and regulatory changes that may impact project execution.
Qualifications:
  • Bachelor's degree in life sciences, pharmacy, chemistry, or a related field. A Master's degree or PMP (Project Management Professional) certification is preferred.
  • 5+ years of project management experience in the pharmaceutical or biotechnology industry.
  • Experience with drug development, clinical trials, and regulatory submissions.
  • Strong leadership and team management skills.
  • Excellent organizational and time management abilities.
  • Proficiency in project management software (e.g., MS Project, Smartsheet, etc.).
  • In-depth understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other regulatory frameworks.
  • Exceptional communication skills, both verbal and written.
  • Strong problem-solving and decision-making skills.

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