Execute the clinical audit program, including scheduling, planning, reporting, and resolution of audits.
Ensure compliance with worldwide regulations, ICH-GCP, AbbVie policies, and sponsor requirements.
Provide advice and support on GCP and quality topics to business partners and support inspections.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. It is a large biopharmaceutical company committed to integrity, innovation, and community service.
Provide final signatory approval of promotional and non-promotional materials in line with the PMCPA Code of Practice.
Support brand teams and ensure compliance with ABPI, MHRA, and international codes.
Act as a subject matter expert and confidently present code cases to encourage team learning.
AbbVie discovers and delivers innovative medicines and solutions in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company, it operates with integrity, drives innovation, and fosters an inclusive culture.
Review appeals of adverse benefit determinations within federal and state regulatory timeframes.
Apply medical policy, coding guidelines, and contractual requirements to assess coverage decisions.
Collaborate with medical divisions and respond to state insurance department inquiries regarding benefit complaints.
Arkansas Blue Cross and Blue Shield is a health insurance provider serving Arkansas. It is consistently ranked as one of the best places to work in Central Arkansas, with an inclusive culture and an average employee tenure of 10 years.
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.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.