Intermediate (2-5 years of experience)
Summary of the Role
The Pharmaceutical Project Manager is responsible for leading cross-functional teams in the development and commercialization of new drugs, overseeing clinical trials, regulatory submissions, and product launch activities. They ensure that projects are completed on time, within budget, and in compliance with regulatory standards.
Required Skills
Excellent leadership and team management skills.
Proficient in project management software and tools.
Strong communication, negotiation, and interpersonal skills.
Ability to manage multiple projects simultaneously and prioritize tasks.
Analytical thinking and problem-solving abilities.
Strong attention to detail and organizational skills.
Qualifications
Bachelor's or master's degree in a life sciences field, pharmacy, or related discipline.
Minimum of 2 years of experience in project management within the pharmaceutical industry.
Strong understanding of the drug development process and regulatory requirements.
Experience in managing projects that involve clinical trials and regulatory submissions.
PMP (Project Management Professional) certification is desirable.
Familiarity with GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and GCP (Good Clinical Practices).
Responsibilities
Lead and coordinate cross-functional project teams consisting of R&D, regulatory affairs, quality assurance, manufacturing, marketing, and other departments.
Develop and manage detailed project plans, including timelines, budgets, resources, and risk assessments.
Ensure compliance with regulatory requirements and submission deadlines for new drug applications and clinical trial documentation.
Facilitate communication between internal departments and external stakeholders, such as clinical research organizations and regulatory bodies.
Monitor project progress and implement corrective actions as necessary to address delays or other issues.
Prepare and present project updates and strategic recommendations to senior management.
Collaborate with finance and business development teams to assess project feasibility and return on investment.
Manage relationships with vendors, suppliers, and contract manufacturers.