Director, Medical Information and Drug Safety

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.
Celltrion Healthcar
e, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.

Celltrion Healthca
re provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

Reporting to the Executive Medical Director Head of Scientific & Medical Communications- is responsible for leading Medical Information operations and supporting Drug Safety/Pharmacovigilance activities across the Celltrion USA portfolio.

The role will oversee the development, review, maintenance, and dissemination of accurate, balanced, scientifically substantiated medical information for healthcare professionals and internal stakeholders while ensuring compliance with applicable regulatory requirements and company policies. The incumbent will also serve as a key Medical Affairs representative supporting adverse event reporting, product complaint management, pharmacovigilance compliance activities, safety training, vendor oversight, and cross-functional safety governance.

The position works closely with Medical Affairs, Regulatory Affairs, Pharmacovigilance, Clinical Development, Medical Communications, Commercial, Legal, Quality, and Global Headquarters teams to support the safe and appropriate use of Celltrion products and ensure compliance with U.S. regulatory requirements.

• Lead Medical Information activities for the Celltrion U.S. portfolio.
• Provide high-quality, accurate, balanced, and timely responses to unsolicited medical information requests from healthcare professionals and other authorized stakeholders.
• Develop, review, and maintain Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), scientific response documents, and medical information resources.
• Support escalated and complex medical information inquiries requiring customized scientific responses.
• Monitor and manage Medical Information inboxes, call center activities, inquiry trends, and service-level metrics.
• Partner with Medical Affairs leadership to develop medical education content, scientific communication materials, training resources, and field medical support tools.
• Maintain Medical Information systems, databases, reference libraries, and digital asset management platforms.
• Develop Medical Information metrics and reports to identify trends, emerging clinical questions, and evidence gaps.
• Support preparation and maintenance of AMCP dossiers and payer evidence resources.
• Collaborate with Medical Communications and Publications teams to ensure consistency and scientific accuracy across materials.

• Act as the primary U.S. Medical Affairs liaison supporting Pharmacovigilance and Drug Safety activities.
• Ensure adverse events, product complaints, and special situation reports are identified, documented, processed, and escalated in accordance with company procedures and regulatory requirements.
• Support implementation and maintenance of local pharmacovigilance processes, standard operating procedures (SOPs), and work instructions.
• Collaborate with Global Pharmacovigilance teams to ensure compliance with FDA, global, and local safety reporting requirements.
• Participate in safety signal evaluation and safety data review…