Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances.  We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through three strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, and Medical Strategy and Communications.

We are seeking a life-sciences professional with healthcare regulatory experience to serve as the Director of Regulatory Affairs within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.

The Director of Regulatory Affairs will play a vital role in the management of clients, billable projects, and staff. This position is responsible for ensuring that scientific content is accurate and well organized and evaluating and analyzing scientific information to support the underlying integrity of the projects. This role requires an expert level understanding of processes adhered to by pharmaceutical and medical device firms, and scientific data and nomenclature, as well as the ability to communicating complex scientific principles to non-scientists, scientists, and physicians.

Additional duties and responsibilities include:

• Manage FDA Advisory Committee Programs: Play a senior management role in projects involving FDA Advisory Committee management, including, leading team meetings, managing project timelines, developing slide decks, and drafting briefing books
• Manage Regulatory Project: Play a senior role in provide guidance to clients relating to drug and medical device safety and efficacy evaluations and activities related to FDA product approvals
• Scientific Summary and Analysis: Review scientific studies and data relevant to a particular scientific issue and provide meaningful written and/or oral critical analysis and integration as to how it affects the client objectives
• Client Interaction: Provide oral and written communication with clients to convey project status, interim reports, and final project deliverables
• Program Management: Supervise client projects and ensure that they are completed with high degree of accuracy and quality and that they are within budget and on time
• Budget Preparation and Oversight: Provide budget estimates for project proposals and ensure that projects stay within budget parameters
• Management and Oversight: Oversees junior staff on client-related projects and administrative responsibilities
• Marketing Initiatives: Conceive, formulate, and implement effective marketing initiatives designed to identify leads and expand project work
• Review and Revise Work Product: Review written work product for clarity and style and revise as necessary
• Expand Projects: Possess ability to identify opportunities to expand existing client projects into larger and more profitable jobs

The ideal candidate will have an advanced degree in a life-sciences field, healthcare regulatory experience, and consulting experience in the pharmaceutical or medical device industry.

Additional Requirements and Qualifications

• Relevant work experience; preferably in regulatory affairs and/or project management; previous experience with regulatory submissions, regulatory body meetings (e.g. FDA Advisory Committees) a plus
• Proficient and comfortable with scientific/medical data and nomenclature
• Ability to effectively communicate complex scientific and regulatory principles to non?scientists (as well as to scientists and healthcare professionals)
• Proficient with Word, Outlook, Excel, and PowerPoint
• Expert skills in internet searching and web browsing related to life sciences and regulatory affairs
• Eagerness to work independently and in teams in a fast?paced environment
• Excellent ability to interpret scientific charts, tables and figures and communicate summary of findings
• Passion for producing and presenting scientific data in oral presentations or written reports

Benefits:

We offer our employees a comprehensive benefits package that focuses on what matters to you – health and well-being, personal finances, professional development, and a healthy work/life balance:

• Competitive salary plus bonus scheme
• Medical, dental, and vision insurance options
• 401(k) plan with employer match
• Generous amount of paid time off annually + 10 paid holidays
• Employee Assistance Program
• Company-paid short-term and long-term disability coverage
• Flexible spending accounts for health and dependent care