A free Jobstore account is required to proceed to the employer site.
Title: Program Manager
Description
Location: Onsite
Status Type: Full Time
Qualifications
Required:
Bachelor of Science in Engineering or Life Science
Minimum 8 years of experience in a regulated industry, preferably at least 3 years in medical devices, pharmaceuticals, and/or combination products
Experience in product or process development activities/process
Minimum 3 years of experience leading cross-functional, matrixed teams; experience managing external customers/clients preferred
Experience directly managing resources, budget, milestones, and detailed activities for large-scale projects
Experience managing people directly preferred
Experience directly managing customers, partnerships, alliances, or external contracts preferred
Experience in additional functional areas (e.g., quality, regulatory, human factors, manufacturing, or engineering) preferred
Experience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standards
Proficiency utilizing Microsoft Office suite (Word, Excel, PowerPoint, Project)
Preferred
Manage integration across companies for co-sponsored projects
Master 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 experience
PMP or CPM
Skills & Competencies
Leads cross-functional team, including driving accountability and responsibility for results and forward progress
Collaborates effectively with diverse stakeholders; demonstrates partner commitment and customer orientation
Communicates effectively in writing, including ability to write in a clear, concise, logical, and grammatically correct manner
Seeks to understand when listening to others; demonstrates awareness of what is requested; communicates orally in a professional manner that inspires confidence
Exercises 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 tact
Demonstrates high attention to detail; conveys excellence in partner deliverables
Distills complicated topics for intended audience; facilitates large discussions, and adjusts/adapts/responds to real-time feedback
Leads and executes strategic plans and workstreams, including planning, organizing, securing, and managing resources to achieve goals
Solves problems, including providing clarity in defining problem statements in ambiguous, complex situations; draws logical conclusions
Sets clear goals, delegates effectively, and leverages the skills and expertise of others
Influences without direct authority; maintains rational and objective demeanor when faced with stressful situations
Physical Requirements
Ability to remain in stationary position for extended periods of time
Ability 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 location
Responsibilities
Manage 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 program
Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as key contact for program; establish credibility with pharma partner
Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work independently with limited oversight
Leverage team skills and experience to achieve program/project goals; communicate clear expectations to team members in order to meet deadlines
Identify business and process issues; model a culture of quality and continuous improvement
Maintain awareness of new and changing processes on programs/projects; identify potential risks for pharmaceutical partners; implement necessary changes to maintain compliance
Model teamwork, diversity, and inclusion within team, between teams and other groups
Nearest Major Market: Cincinnati
A free Jobstore account is required to proceed to the employer site.
US
