Sr. Clinical Compliance Associate
Posted on 1/13/2024
INACTIVE
Arrowhead Pharmaceuticals

201-500 employees

RNAi-based gene-silencing therapeutics
Company Overview
Arrowhead Pharmaceuticals stands out in the biopharmaceutical industry through its focused application of RNA interference (RNAi) mechanisms to develop targeted therapies for genetic diseases, exemplified by its candidate plozasiran aimed at reducing ApoC3 protein levels to manage severe hypertriglyceridemia. The company's proprietary TRiM platform demonstrates a competitive edge by enabling tissue-specific gene silencing, which has shown promise in early clinical trials, such as the AROAPOC3-2001 study, to improve lipid levels safely and effectively. Arrowhead's approach to drug development not only streamlines manufacturing and potentially reduces costs but also positions the company as a leader in RNAi therapeutics, with ongoing research that could transform treatment paradigms for patients with lipid disorders.
Biotechnology

Company Stage

N/A

Total Funding

$899.9M

Founded

2004

Headquarters

Pasadena, California

Growth & Insights
Headcount

6 month growth

10%

1 year growth

32%

2 year growth

63%
Locations
Pasadena, CA, USA • San Diego, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Quality Assurance (QA)
PowerPoint/Keynote/Slides
CategoriesNew
Risk & Compliance
Legal & Compliance
Requirements
  • At least 3 years of experience in Clinical Operations or similar function
  • At least 2 year of experience working in eTMF system set-up and maintenance (preferably experience with Veeva Vault eTMF)
  • Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines
  • Experience with eTMF systems and TMF reference model
  • Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
  • Proficient in MS Office (Word, Excel, and PowerPoint)
  • Ability to work in a team or independently
  • Effective interpersonal, written and verbal communication skills
  • Able to critically evaluate job tasks and the impact on overall study execution
  • Strong problem-solving capabilities
  • Effectively collaborates with Study Team members
  • Exceptional organizational skills with the ability to multi-task and prioritize
  • Attention to detail
  • Ability to work with distributed team members and outside vendors
Responsibilities
  • Support study teams with eTMF set-up and maintenance
  • Manage assignment and tracking of Veeva Vault study
  • Prepare eTMF QC templates for quality eTMF reviews
  • Initiate quarterly eTMF reviews across programs
  • Set up and review flash reports on eTMF vendor metrics
  • Participate in review of SOPs and WIs during annual
  • Assist DCCT with new hire onboarding and training
  • Manage Vendor Issues Tracker with issues submitted from study team
  • Participate in health authority inspections preparation activities
  • Assist DCCT and QA with document preparation for any internal gap assessments or audits
  • Prepare training refreshers for Clinical Operations staff on internal SOP/WI
  • Assist ADCCT with development of Clinical Operations documents (forms, templates, SOPs/WIs)