IQVIA Regulatory & Start Up Specialist (Home-based) - IQVIA MedTech in Rockville, Maryland
IQVIA MedTech is now hiring for a Regulatory & Start -Up Specialist for a home-based opportunity.
Prepares, performs and follows-up on regulatory submissions to Institutional Review Boards (IRB) and other applicable bodies according to the relevant legislation and guidelines for clinical trials with medical devices (e.g. ICH-GCP, ISO 14155, MDR, FDA 21 CFR) under supervision of the Regulatory & Start-up Manager.
Search and verifies IRB submission requirements.
Drafts IRB submission documents (e.g. application form, ICF, …).
Prepares IRB and other applicable submission packages.
Follows-up on development and collection of required regulatory documentation.
Ensures timely filing of submission documents.
Ensures regulatory tracking systems/databases remain updated.
Follows-up on submission status and ensures resolution of all questions and comments under supervision of the Regulatory & Start-up Manager.
Acts as an intermediary between the involved different parties, which may include IQVIA MedTech employees, Regulatory Authorities, Review Committees, third party vendors (e.g. consultants, translation agencies), participating site staff (e.g. investigators, study coordinators) and clients.
Pro-actively identifies regulatory related issues and discuss strategies with the Regulatory & Start-up Manager.
Reports on activities and IRB status in a timely fashion to the Regulatory & Start-up Manager.
Assures adherence to Good Clinical Practices and compliance with all IQVIA MedTech SOPs, study procedures and regulatory requirements.
Attends study-related, company, departmental, and external meetings, as required.
Ensures all study deliverables are completed per IQVIA MedTech and study timelines.
Knowledge, skills and abilities:
You have a (para-) medical or scientific degree and by preference relevant experience in clinical research and clinical trial submissions.
Fluent in English, by preference in more languages.
Excellent written and verbal communication skills.
Excellent planning and organizational skills with proven time-management capability.
Detail-oriented and pro-active with a strong analytical and problem-solving mindset.
Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
Able to handle several priorities within multiple, complex trials.
Able to reason independently and recommend specific solutions in clinical settings.
Able to work independently, prioritize, and work within a matrix team environment.
Experience with standard Microsoft Office programs
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.