Remote Life Sciences Project Manager

LifeSciences Regulatory Solutions, LLC; United States; On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Dental insurance

Health insurance

Home office stipend

Paid time off

Job summary

LifeSciences Regulatory Solutions, LLC is seeking a Senior Project Manager to lead cross-functional drug and medical device development projects remotely across the United States. You will drive planning, budgeting, risk management, and client communication to ensure on-time, in-scope project delivery.

You will coordinate scientific, regulatory, clinical, and quality stakeholders, monitor progress, report to clients, and identify opportunities for services within existing programs, while

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Business, Project Management, or a related field.
• 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.

Responsibilities

• 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

Project management

Cross-functional leadership

Regulatory knowledge

Risk management

Budgeting

Stakeholder communication

Analytical thinking

Excel proficiency

Education

Bachelor's degree in Life Sciences / related field

MS / MBA / PharmD preferred

Tools

SmartSheet

Microsoft Project

Microsoft Office Suite

Job description

LifeSciences Regulatory Solutions, LLC is seeking a Senior Project Manager to lead cross-functional drug and medical device development projects remotely across the United States. You will drive planning, budgeting, risk management, and client communication to ensure on-time, in-scope project delivery.

You will coordinate scientific, regulatory, clinical, and quality stakeholders, monitor progress, report to clients, and identify opportunities for services within existing programs, while