Manage the operational coordination and continuous improvement of the Medical, Legal, and Regulatory (MLR) review process for promotional materials. Ensure all materials are reviewed, approved, and archived in compliance with FDA regulations and company policies.
Cristcot
8 Remote Job Openings at Cristcot
Lead the commercial launch of a ulcerative colitis therapy by managing contract sales organizations (CSOs) and external agency partners. Establish governance, performance metrics, and strategic field execution to achieve corporate revenue goals.
The Document Management Lead owns the company's document organization standards across Microsoft Teams and SharePoint. They are responsible for creating structures, enforcing naming conventions, and training employees to maintain a searchable document environment.
Manage and oversee relationships with drug substance and drug product suppliers to ensure reliable and compliant production of combination products. Lead technology transfers, monitor supplier performance, and ensure adherence to GMP and FDA quality standards.
Sr. Manager/Associate Director/Director, Packaging & Labeling Operations
Cristcot
·
Full Time
·
a month ago
Cristcot
Lead the strategic and operational delivery of compliant packaging and labeling for clinical and commercial products. Manage external CMOs and vendors while ensuring alignment across quality, regulatory, and supply chain functions.
Develop and execute national account strategies to ensure successful commercial product launch and patient access. Lead negotiations and relationship management with PBMs, GPOs, payers, and specialty pharmacies.
Lead the development and management of trade, distribution, and contract operations infrastructure to support the company's first commercial product launch. Oversee gross-to-net management, government pricing compliance, and operational relationships with wholesalers and specialty pharmacies.
Medical Science Liaison - Midwest (IL, WI, MN, IA, NE, TN)
Cristcot
·
Full Time
·
a month ago
Cristcot
Develop and maintain professional relationships with healthcare practitioners to provide scientific support for ulcerative colitis therapies. Collaborate cross-functionally with internal teams to deliver medical insights and support research and development programs.