at IQVIA in Aurora, Illinois, United States
Job Description
IQVIA MedTech is seeking an Associate Principal with strong Medical Device Regulatory Submissions experience.
JOB OVERVIEW
Manages multiple MedTech Regulatory consulting projects of varying complexity and ensures on-time and on-budget delivery for clients in MedTech or related industries. Serves as point person on engagements. Contributes to new business development and maintaining and strengthening client base.
ESSENTIAL FUNCTIONS
+ Define and implement regulatory strategic plans in the applicable program areas
+ Manage project deliverables including regulatory strategy assessments, regulatory plans, progress reports, presentations, premarket submissions, communications with regulatory authorities. Adjust resources, deliverables and client expectations accordingly.
+ Leverages business experience and acumen in identifying strategic alternatives and project approach to client questions.
+ Serves as key point of contact with client.
+ Provides follow-up with client after project deliverable has been completed to ensure client satisfaction.
+ Monitor project time charges within the functional group.
+ Manages project teams/staff including both internal and external resources, when applicable, in the design, development and delivery of client deliverables.
+ Ensures clear communication throughout projects and within the team.
+ Supports the development of intellectual property for use on future engagements.
+ May manage the process of proposal preparation and/or modifications including overall bid integrity.
+ Develops and/or elevates new business opportunities through the identification of follow-on work and new leads.
+ Develops broader and deeper knowledge of consulting methodologies and MedTech market through on the job experience and training.
+ Provides direction, advice and intellectual leadership to clients and delivery teams.
+ Directs consulting teams through consistent participation in team meetings.
+ Provides high level input to, and ensures the development of, client reports and presentations and delivery of all or significant portions of findings to client.
+ Maintain proficiency of skills and knowledge and remain current with industry trends based on current literature, regulatory guidance documents, application of new technology, attendance at professional meetings, etc.
+ May present relevant regulatory topics to industry clients and at professional conferences. Publish materials such as fact sheets, white papers.
+ Shares subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.
+ Leads ad hoc work streams on critical people-related issues such as recruitment, learning and development.
+ May serve as a coach to junior staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
+ Sound knowledge of regulatory processes and requirements for all medical device and diagnostics classifications
+ Sound knowledge and understanding of FDA and Health Canada submission processes
+ Project planning methodology, problem analysis, development and technical writing for marketing applications and communications with regulatory authorities
+ Strong influencing and negotiation skills.
+ Strong interpersonal and organizational skills.
+ Excellent verbal and written communication skills.
+ Ability to lead, guide and motivate project team members to achieve desired results.
+ Ability to establish and maintain effective working relationships with coworkers, managers and clients
QUALIFICATIONS
+ Bachelor’s Degree in life science related discipline or related field [Req]
+ Master’s Degree/ MBA or Higher degree [Pref]
+ 8-10 years professional experience in consulting, MedTech and/or healthcare industry with evidence of career progression [Req]
+ Demonstrable experience in and commitment to the life sciences and/or healthcare industries.
+ A track record of leadership and people development.
+ A willingness and ability to travel.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
New York City Pay Transparency : The salary range for this role is $167,400 – $226,700.The actual salary will vary based on factors like candidate qualifications and competencies.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
