8+ years in regulated industry, 5+ years in medical devices or pharmaceuticals
3+ years in product development
3+ years leading cross-functional teams, managing external clients preferred
3+ years managing resources, budget, milestones for large projects
Direct people management experience
Experience with ISO, FDA, or MDD regulations
Proficient in Microsoft Office Suite
Responsibilities
Manage drug partner projects from inception to launch
Support all phases of the product development process
Identify and implement best practices across programs
Maintain positive relationships with pharmaceutical partners
Foster strong internal team relationships and exercise autonomy
Leverage team skills to meet project goals
Identify business issues and facilitate organizational change
Ensure compliance and adapt to new processes
Benefits
Full-time status with onsite work requirement
Supportive culture encouraging diversity and inclusion
Opportunity to work with leading pharmaceutical partners
Focus on continuous improvement and quality
Engagement in a variety of large-scale projects
Full Job 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 5 years in medical devices, pharmaceuticals, and/or combination products
Minimum 3 years of experience in product development activities/process
Minimum 3 years of experience leading cross-functional, matrixed teams; experience managing external customers/clients preferred
Minimum 3 years of experience directly managing resources, budget, milestones, and detailed activities for large-scale projects
Experience managing people directly
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:
Experience directly managing customers, partnerships, alliances, or external contracts
Experience in additional functional areas (e.g., quality, regulatory, human factors, engineering, manufacturing, or strategic marketing)
Master of Business Administration (MBA) or Master of Science in Engineering/Life Science
Project Management (e.g., PMP, CAPM, CPMP, or Project Director) Certification
Skills & Competencies:
Leads cross-functional team, including driving accountability and responsibility for results and forward progress
Collaborates effectively with diverse stakeholders, including ability to facilitate/translate perspectives into group consensus; models 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; fosters a culture of excellence in partner deliverables
Distills complicated topics for intended audience; facilitates large discussions, and adjusts/adapts/responds to real-time feedback
Designs, 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 and negotiates conflict; 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.
Identify and implement best practices on programs; ensure consistency and thoroughness of deliverables throughout program
Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as ambassador for program; inspire confidence with pharma partner
Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work autonomously and exercise good judgement
Maximize 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; facilitate change within the organization; 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
Embody Enable values
Foster teamwork, diversity, and inclusion within team, between teams and other groups
