Project Coordinator – Clinical and Regulatory Life Sciences

Are you ready to #BeEpista? At Epista, you will grow a career in a setting that cherishes curiosity, integrity, and development.

Epista Life Science is dedicated to defining and delivering process, technology and compliance excellence. Since our founding, we've expanded into multiple countries with big ambitions for the future. Our team is our superpower – and we want you to be a part of it. If you're interested in #BeingEpista, get in touch, we want to hear from you.

We are seeking a detail-oriented and proactive Project Coordinator to support clinical and regulatory project teams within the pharmaceutical industry. This role will serve as a key liaison between internal teams, clients, and external vendors. The successful candidate will bring a strong understanding of clinical research and regulatory environments, with proven experience coordinating deliverables, managing project governance, and driving stakeholder alignment in a consulting context.

Competencies

• Strong organizational and time management skills.
• Strong consulting experience.
• Proactive problem-solving and critical thinking.
• Team-oriented with ability to work independently.
• Adaptability in a dynamic regulatory and clinical environment.

Qualifications:

• Bachelor's degree in Life Sciences, Project Management, or related field (Master's preferred).
• 5+ years of experience in project coordination or administration, preferably in the pharmaceutical, biotech, CRO, or regulatory sector.
• Knowledge of clinical research processes, regulatory submission pathways, and industry standards (ICH GCP, FDA, EMA).
• Strong proficiency in MS Office Suite (Excel, PowerPoint, Word); experience with project management tools (e.g., MS Project, Smartsheet, or similar).
• Experience with clinical or regulatory systems (e.g., Veeva Vault, CTMS, eTMF, RIM).
• Excellent written and verbal communication skills with attention to detail.
• Ability to multitask, prioritize, and work in a fast-paced, deadline-driven environment.

As an Epista, you'll be working at the intersection of compliance and business as a part of our highly skilled and dedicated team. You'll be involved in a wide variety of projects, primarily focusing on Project Coordination.. Much of your time will be spent with our clients - international pharma and medical technology companies. Your daily activities might include:

• Project Planning & Coordination
• Support Project Managers and cross-functional teams in planning, tracking, and executing project deliverables.
• Develop and maintain project trackers, timelines, and dashboards.
• Schedule and coordinate project meetings, workshops, and teleconferences.
• Documentation & Compliance
• Maintain project documentation (project plans, meeting minutes, decision logs, issue/risk trackers).
• Ensure project activities align with clinical trial regulations (ICH GCP, FDA, EMA) and regulatory submission requirements.
• Communication & Stakeholder Management
• Act as the central point of contact for project communications and updates.
• Prepare status reports and presentations for senior leadership, regulatory, and clinical operations teams.
• Facilitate communication between sponsors, CROs, and internal departments (Regulatory Affairs, Clinical Operations, Quality, etc.).
• Operational Support
• Assist with budget tracking, resource planning, and vendor oversight activities.
• Support inspection readiness activities, ensuring audit trails and documentation are current.

Epista is a team of pioneers. We unlock each consultant's potential to continuously improve. We pioneer new ways to stay in control of patient safety and product quality and question the status quo in everything we do.

Our unique team spirit makes a positive impact – on our clients and the Life Science industry. Here, you're never alone. We all work together for everyone's success. And each individual is strengthened by the knowledge of the group.

We're proud to be Epista, for good reason. Are you ready to #BeEpista?

Epista is an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need. This position requires the selected candidate to be legally authorized to work in the United States without the need for current or future visa sponsorship

Please note that applications from third-party recruiters or recruitment agencies will not be accepted at this time. Applications must be submitted directly by individual candidates interested in this position.

Location:

East Coast

Application deadline:

As soon as possible

Employment date:

1. October 2025