Sr. Project Coordinator
TalentHop · United States · 2 wk ago
RemoteRemoteProject ManagementFull-time
This is a Fully Remote Job About Our Client:The organization operates in the biopharma sector, focusing on accelerating breakthrough science and delivering life-enhancing therapies to patients. It supports various clients through critical phases of drug discovery, approval, and commercialization. The organization emphasizes strategic, solutions-driven approaches that yield significant real-world outcomes in product development and delivery. It is recognized for fostering a positive work environment, career growth, and innovation, evidenced by awards such as BioSpace's "Best Places to Work". About the Opportunity:The SENIOR PROJECT COORDINATOR role is designed to support the successful planning, execution, and delivery of complex cross-functional initiatives within a medical device environment. This position collaborates with stakeholders across multiple departments to ensure projects align with business objectives, stay on schedule, and maintain scope. The role contributes by managing regulated product projects and product lifecycle activities, directly impacting the organization's operational effectiveness and regulatory compliance. Responsibilities:Coordinate and support multiple cross-functional projects through all phases.Develop and maintain project plans, timelines, milestones, and status reports.Facilitate collaboration among technical, operational, and commercial teams.Track project deliverables, dependencies, risks, issues, and action items.Support product development, launch, remediation, and lifecycle management.Prepare project documentation including agendas, minutes, decision logs, and executive updates.Monitor project performance and recommend solutions for schedule or resource issues.Ensure compliance with medical device regulations, quality systems, and procedures.Assist with governance activities such as steering committee meetings and leadership reviews.Coordinate change management, communication plans, and stakeholder engagement.Support process improvement initiatives for better project execution.Maintain project data in management tools and reporting systems. Requirements:Bachelor's degree in Business, Engineering, Life Sciences, Healthcare Administration, or related field preferred.Project management certification such as PMP, CAPM, or Agile preferred.Over 5 years of project coordination or management experience.Strong knowledge of project management principles and methodologies.Experience with complex cross-functional projects in medical device, healthcare, life sciences, or regulated industries.Familiarity with FDA-regulated products and medical device quality systems preferred.Experience collaborating with product development, manufacturing, quality, and regulatory teams.Proficiency in Microsoft Office, Project, Smartsheet, Jira, or similar tools.Excellent organizational, communication, and stakeholder management skills.Ability to manage multiple priorities in a fast-paced environment.Knowledge of Design Controls, Risk Management, CAPA, and Product Lifecycle Management preferred.Experience supporting product launches, acquisitions, integrations, or transformations.Experience working with global teams and external partners. Pay Range and Compensation Package:The pay range and compensation package for this role will be determined based on the candidate's experience, skills, and other relevant factors. Equal Opportunity Statement: Our client is an equal opportunity employer. They celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, or national origin. Note:TalentHop is a recruitment partner of this role. Please note that all employment decisions, including candidate assessment, interviews, hiring, compensation, and employment terms, are made exclusively by the hiring employer.