Program Manager

Title: Program ManagerDescriptionLocation: OnsiteStatus Type: Full TimeQualificationsRequired:Bachelor of Science in Engineering or Life ScienceMinimum 8 years of experience in a regulated industry, preferably at least 3 years in medical devices, pharmaceuticals, and/or combination productsExperience in product or process development activities/processMinimum 3 years of experience leading cross-functional, matrixed teams; experience managing external customers/clients preferredExperience directly managing resources, budget, milestones, and detailed activities for large-scale projectsExperience managing people directly preferredExperience directly managing customers, partnerships, alliances, or external contracts preferredExperience in additional functional areas (e.g., quality, regulatory, human factors, manufacturing, or engineering) preferredExperience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standardsProficiency utilizing Microsoft Office suite (Word, Excel, PowerPoint, Project)PreferredManage integration across companies for co-sponsored projectsMaster of Business Administration (MBA) or Master of Science in Engineering/Life Science (Preferred)Project Management (e.g., PMP or CAPM) Certification (Preferred)Knowledge of regulatory requirements governing drug and device development, human factors, commercial manufacturing operations, regulatory approvals and/or product launch experiencePMP or CPMSkills & CompetenciesLeads cross-functional team, including driving accountability and responsibility for results and forward progressCollaborates effectively with diverse stakeholders; demonstrates partner commitment and customer orientationCommunicates effectively in writing, including ability to write in a clear, concise, logical, and grammatically correct mannerSeeks to understand when listening to others; demonstrates awareness of what is requested; communicates orally in a professional manner that inspires confidenceExercises discernment in dissemination of information and sense of urgency; escalates issues to ensure timely and relevant responses; demonstrates ability to handle sensitive information with discretion and tactDemonstrates high attention to detail; conveys excellence in partner deliverablesDistills complicated topics for intended audience; facilitates large discussions, and adjusts/adapts/responds to real-time feedbackLeads and executes strategic plans and workstreams, including planning, organizing, securing, and managing resources to achieve goalsSolves problems, including providing clarity in defining problem statements in ambiguous, complex situations; draws logical conclusionsSets clear goals, delegates effectively, and leverages the skills and expertise of othersInfluences without direct authority; maintains rational and objective demeanor when faced with stressful situationsPhysical RequirementsAbility to remain in stationary position for extended periods of timeAbility to consistently operate a computer, and other office equipment (e.g., printer, telephone, etc.)Ability to work in an open office environment, on-site at an Enable locationResponsibilitiesManage drug partner program(s) and project(s) from inception through commercial launch and life-cycle management (i.e., product retirement); develop, track, analyze and communicate key performance indicators on the program, including the effectiveness of technical strategies, regulatory pathways, clinical build progress, project execution, and product development risks (e.g., alignment to schedule, scope, resources)Support all phases of the product development process from Concept to Launch; understand Design Control principles and support gate-keeping, design freezes, design reviews, change control, sign-offs, etc.Implement best practices on programs/projects; ensure consistency and thoroughness of deliverables throughout programDevelop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as key contact for program; establish credibility with pharma partnerDevelop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work independently with limited oversightLeverage team skills and experience to achieve program/project goals; communicate clear expectations to team members in order to meet deadlinesIdentify business and process issues; model a culture of quality and continuous improvementMaintain awareness of new and changing processes on programs/projects; identify potential risks for pharmaceutical partners; implement necessary changes to maintain complianceModel teamwork, diversity, and inclusion within team, between teams and other groupsNearest Major Market: Cincinnati