What are the responsibilities and job description for the Pharmaceutical Project Manager - HYBRID position at Sierra Solutions?
Job Summary:
The Pharmaceutical Project Manager is responsible for leading and managing pharmaceutical product development projects, ensuring the timely and successful delivery of products from research and development through to commercialization. This position involves overseeing cross-functional teams, managing budgets, timelines, and resources, and ensuring compliance with regulatory standards and internal policies.
Key Responsibilities:- Project Planning and Coordination:
- Develop detailed project plans that outline timelines, milestones, resource allocation, and budgets.
- Coordinate cross-functional teams, including research, development, regulatory affairs, quality assurance, and marketing.
- Identify potential project risks and work proactively to mitigate them.
- Leadership and Team Management:
- Lead project teams, providing clear direction and motivation to team members.
- Foster a collaborative environment, encouraging open communication and efficient problem-solving.
- Monitor team performance and offer feedback for continuous improvement.
- Regulatory and Compliance Oversight:
- Ensure that projects adhere to regulatory guidelines, including FDA, EMA, and other global regulatory standards.
- Work closely with regulatory affairs to manage submissions and approvals, ensuring timely progress.
- Review regulatory documentation and assist in preparing submissions.
- Budget and Resource Management:
- Develop and manage project budgets, ensuring resources are allocated appropriately.
- Track project expenditures and report on financial status to senior management.
- Ensure resource allocation aligns with project priorities and deadlines.
- Risk Management:
- Proactively identify potential project risks and develop strategies for mitigation.
- Report on project risks, issues, and timelines to senior management.
- Adapt project plans as needed to overcome obstacles and stay on schedule.
- Stakeholder Communication:
- Serve as the primary point of contact for stakeholders, including internal teams, external partners, and regulatory bodies.
- Communicate project status, updates, and concerns to all stakeholders.
- Prepare regular project reports and presentations for senior leadership and other key stakeholders.
- Quality Assurance:
- Ensure the project meets quality standards and regulatory requirements.
- Work with quality assurance teams to address any issues related to product quality.
- Product Launch and Post-Launch Support:
- Oversee the planning and execution of product launches, including coordination of marketing, sales, and distribution efforts.
- Ensure the transition from development to production is smooth and well-documented.
- Education: Bachelor's degree in Pharmacy, Life Sciences, or a related field. A Master's degree or PMP (Project Management Professional) certification is preferred.
- Experience:
- Minimum of 5-7 years of experience in the pharmaceutical industry, with at least 3 years in project management.
- Experience in managing cross-functional teams and complex projects in drug development.
- Skills:
- Strong understanding of pharmaceutical development processes, regulatory requirements, and industry best practices.
- Excellent communication, leadership, and interpersonal skills.
- Ability to manage multiple projects and priorities simultaneously.
- Strong problem-solving and decision-making abilities.
- Proficiency in project management tools and software (e.g., Microsoft Project, Smartsheet, etc.)
