Regulatory Lead
Topography
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Remote
Posted on Wednesday, April 3, 2024
Topography Health is a first-of-its-kind, physician-focused clinical trials platform. We offer a full stack of tools and services to empower doctors to gather evidence within an existing practice. Our mission is to accelerate clinical research by increasing the investigative capacity of every physician, creating a new world of medicine where patients have seamless access to advanced research. We care deeply about creating data sets that are more inclusive and representative, and we’re determined to change how research is conducted at the community level. We’re backed by Andreessen Horowitz, Bain Capital Ventures, and other great financial and strategic partners.
OVERVIEW
This role will act as a key intermediary between research teams, regulatory authorities, and sponsors. You will be managing internal communications, Investigator Site Folder/Regulatory Binder contents and documenting adherence to regulations and protocols, particularly with IRBs and within internal operations. This role requires maintaining well-organized records, preparing and submitting regulatory documents. A strong grasp of FDA and ICH guidelines is required, along with meticulous attention to detail and organizational skills. The Regulatory Lead must stay informed about regulatory trends to assess their impact on trials, contribute to SOPs, participate in audits, and ensure documentation accuracy. Their work is essential to maintaining the integrity of clinical research, streamlining processes, and fostering effective collaboration within a vibrant organizational culture.
KEY RESPONSIBILITIES
Plan resource needs for regulatory operations and workload of regulatory team and strategize growth
Identify program improvement opportunities and lead improvement efforts within team, including technology solutions
Serve as a liaison for essential documentation/regulatory required documentation between the research team, regulatory authorities, and sponsors
Oversee Institutional Review Board (IRB) communications
Oversee the timely submission of clinical trial protocols, amendments, and informed consent documents to IRBs to meet project timelines
Contribute, Review and Approve study related plans/documents as needed.
Perform internal audits and/ or participate in Quality Assurance reviews/audits of the Investigator Site Files/Regulatory Binder as needed
Develop and contribute to the creation and maintenance of regulatory binders and all other essential documents
Foster a collaborative environment and contribute to a positive, dynamic, high-energy organization.
Maintain awareness of and expertise in FDA and ICH guidelines related to regulatory topic
Ensure adherence to all applicable regulatory requirements
Prioritize work across various studies and exercise good judgment in reporting responsibilities in complex documentation through to completion
MINIMUM QUALIFICATIONS
Bachelor's Degree or equivalent 4 years of work experience
5+ years of formal work experience in clinical research, including 3+ years of experience in regulatory, specifically in clinical trials
5+ years of experience with Good Clinical Practice (GCP), FDA, and ICH guidelines
5+ years of experience working with electronic document management systems
2+ years of previous people management/formal mentorship experience
Ability to travel 30% of the time
PREFERRED QUALIFICATIONS
Certification in Regulatory Affairs
3+ years of experience in IRB
3+ years experience as a CRC
Topography is an equal opportunity employer and does not discriminate based on race, age, religion, gender, gender identity, national origin, citizenship status, sexual orientation, disability, political affiliation, or belief. We are committed to creating an inclusive culture.
This job is no longer accepting applications
See open jobs at Topography.See open jobs similar to "Regulatory Lead" BIOS Community.