Precision for Medicine is a precision medicine CRO combining novel trial designs, operational experts, and biomarker analytics with a focus on oncology and rare diseases. It encourages high-energy professionals who thrive in dynamic environments.
Salary Distribution
1 of 9 jobs
$71,350
Min
$71,350
25th
$71,350
Median
$71,350
75th
$71,350
Max
Benefits Overview
1 of 9 jobs
Home Working Allowance
(1)
Life Insurance
(1)
Medical Insurance
(1)
MultiSport Card
(1)
Pension
(1)
Vacation
(1)
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Serve as primary point-of-contact and escalation point for clients, coordinating functional services and vendors to meet quality, scope, cost, and time objectives.
Manage study budget and financial health, ensuring projects remain within scope and identifying out-of-scope activities, while overseeing billing and forecasting.
Develop robust project plans with timelines and risk management, ensure quality management including eTMF inspection readiness, and lead internal and client meetings.