Project Manager
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AI Summary
Lead and manage cross-functional drug and medical device development projects from discovery through commercialization. Ensure projects are delivered on time, within scope, and within budget while maintaining alignment with client and organizational objectives.
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Home office stipend
- Paid time off
Job Purpose:
Leading strategic and operational initiatives as a key partner to the drug and medical device operational teams. Assisting with driving projects forward, identifying new business opportunities from within existing clients, mitigating risks, and driving alignment across departments while ensuring projects are delivered on time, within scope, and budget.
Duties:
- Develop and maintain integrated project plans, timelines, milestones, budgets, resource requirements, project dashboards, and success metrics.
- Lead and manage cross-functional drug and medical device development projects from discovery through commercialization, ensuring alignment with client and organizational objectives.
- Coordinate and facilitate collaboration among scientific, clinical, regulatory, quality, operational, and business stakeholders to ensure successful project execution.
- Monitor project progress, identify risks, dependencies, and bottlenecks, and implement mitigation strategies to maintain project timelines and deliverables.
- Serve as the primary point of contact for clients and internal stakeholders, providing regular project updates, recommendations, and executive-level reporting.
- Manage multiple projects simultaneously, ensuring deliverables are completed on time, within scope, within budget, and in compliance with quality and regulatory requirements.
- Support clinical and product development activities, including study planning, regulatory submissions and meetings, and commercialization readiness.
- Prepare and present project reports, dashboards, and strategic recommendations to clients, leadership, and cross-functional teams.
- Monitor project expenditures and resource utilization, identify budget variances, and recommend corrective actions as needed.
- Identify opportunities for additional services, business growth, and process enhancements within existing client programs.
- Build and maintain strong relationships with clients, external partners, and internal stakeholders to support long-term project and business success.
- Contribute to strategic planning, organizational initiatives, proposal development, and other special projects as assigned.
Skills/Qualifications:
- Bachelor's degree in Life Sciences, Biotechnology, Engineering, Business, Project Management, or a related field; advanced degree (MS, MBA, PharmD, or equivalent) preferred.
- 5+ years of project management experience within pharmaceutical, biotechnology, medical device, diagnostics, CRO, CDMO, or other regulated life sciences environments.
- Demonstrated knowledge of drug and/or medical device development processes, including product development, clinical research, regulatory submissions, quality systems, and commercialization activities.
- Strong project management expertise, including planning, scheduling, budgeting, resource management, risk assessment, and execution of complex cross-functional projects.
- Proven ability to manage multiple priorities simultaneously while delivering projects on time, within scope, and within budget.
- Strong analytical, problem-solving, and critical-thinking skills with the ability to translate complex information into actionable recommendations.
- Excellent verbal, written, presentation, and interpersonal communication skills, with the ability to effectively engage clients, executives, scientists, clinicians, and regulatory professionals.
- Knowledge of applicable regulatory requirements and industry standards, including FDA regulations, GCP, GMP, GLP, ISO standards, and other relevant compliance frameworks.
- Experience utilizing project management tools and business software, including SmartSheet, Microsoft Project, and advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
- Strong organizational, time management, and executive functioning skills with the ability to work independently and manage competing deadlines.
- Customer-focused mindset with a commitment to quality, operational excellence, continuous improvement, and exceptional service delivery.
This is a remote position.
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