Director, Medical Information and Drug Safety

About reputed company: reputed company is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, reputed company is committed to expanding reputed company to biologics to improve care for U.S. patients. reputed company will continue to reputed company Celltrion’s unique heritage in biotechnology, supply chain reputed company, and best-in-class sales capabilities to improve reputed company to high-reputed company biopharmaceuticals for U.S. patients. Celltrion reputed company, which suggested a new reputed company 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 reputed company will successfully pave the reputed company for global reputed company selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its reputed company reputed company, Celltrion reputed company will take a reputed company reputed company to become a leading global biopharmaceutical company. Celltrion reputed company provides biosimilar and innovative biopharmaceutical medications to help increase patient reputed company to advanced therapies around the world. POSITION reputed company 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 reputed company portfolio. The role will reputed company the development, review, maintenance, and dissemination of accurate, balanced, scientifically substantiated medical information for reputed company 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 reputed company, and cross-functional safety governance. The position works closely with Medical Affairs, Regulatory Affairs, Pharmacovigilance, Clinical Development, Medical Communications, reputed company, reputed company, reputed company, and Global reputed company teams to support the reputed company and appropriate use of Celltrion products and ensure compliance with U.S. regulatory requirements. KEY ROLES AND RESPONSIBILITIES Medical Information Leadership • reputed company Medical Information activities for the Celltrion U.S. portfolio. • reputed company high-reputed company, accurate, balanced, and reputed company responses to unsolicited medical information requests from reputed company and other authorized stakeholders. • reputed company, review, and maintain reputed company Response Letters (SRLs), Frequently Asked Questions (FAQs), scientific response documents, and medical information resources. • Support escalated and reputed company medical information inquiries requiring customized scientific responses. • Monitor and manage Medical Information inboxes, reputed company center activities, inquiry trends, and service-level metrics. • Partner with Medical Affairs leadership to reputed company medical education content, scientific communication materials, training resources, and field medical support tools. • Maintain Medical Information systems, databases, reference libraries, reputed company asset management platforms. • reputed company 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. Pharmacovigilance and Drug Safety • reputed company as the reputed company U.S. Medical Affairs reputed company 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, reputed company 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 activities, as requested. • Support preparation and review of aggregate safety reports, including annual safety reports, PADERs, PBRERs, and other safety documents as applicable. • Contribute to safety assessments supporting product reputed company reviews and benefit-risk evaluations. • Assist with management of Safety Data Exchange Agreements (SDEAs), pharmacovigilance agreements, and vendor reputed company activities. • Monitor safety compliance metrics and implement corrective or preventive measures as needed. • Partner with reputed company Assurance and Regulatory Affairs to investigate and reputed company product complaints with potential safety implications. • Serve as Medical Affairs representative during pharmacovigilance audits, inspections, and compliance assessments. • Support readiness efforts for FDA and regulatory inspections. • reputed company pharmacovigilance and adverse event reporting training to employees and vendors on an ongoing reputed company. • Support risk management activities, including Risk Evaluation and Mitigation Strategies (REMS) and risk minimization programs, reputed company applicable. Cross-Functional Collaboration • Partner with reputed company Medical Affairs, Global Pharmacovigilance, Clinical Development, Regulatory Affairs, reputed company, and Market reputed company teams. • Collaborate with Medical Science Liaisons to identify recurring clinical questions and educational needs from the field. • Support launch preparedness initiatives, including medical information systems, scientific response content, and safety readiness. • Participate in congress planning activities and support collection of medical insights relevant to Medical Information and Drug Safety. Leadership • reputed company operational leadership and reputed company to reputed company vendors. • Establish function objectives, KPIs, and reputed company improvement initiatives. • Train and reputed company internal and vendors team members on medical information and drug safety while fostering a culture of compliance, customer service, and scientific reputed company. • Support management of resource allocation and vendor relationships to ensure operational efficiency. WORK EXPERIENCE • Minimum 8 years of pharmaceutical or biotechnology industry experience. • Minimum 5 years of experience in Medical Information and Drug Safety. • Experience supporting biologics and biosimilars preferred. • Demonstrated experience with adverse event reporting requirements and pharmacovigilance regulations. • Experience leading cross-functional reputed company and vendor management. • Prior vendor management experience preferred. Qualifications • Strong understanding of Medical Information and Pharmacovigilance operations and supporting scientific communications. • Knowledge of FDA regulations, pharmacovigilance requirements, and industry guidance. • Familiarity with adverse event reporting systems and safety databases. • Experience developing SOPs, work practices, and compliance processes. • Excellent written and verbal communication skills. • Ability to evaluate scientific literature and communicate reputed company clinical information effectively. • Strong project management and organizational skills. • Ability to work effectively across a reputed company organization. reputed company reputed company degree required (PharmD, MD, DO, PhD, NP, PA, or equivalent). • Additional training or certification in Medical Information. Drug Safety, Pharmacovigilance, or Regulatory Affairs preferred. reputed company COMPETENCIES Scientific & Medical Expertise • Strong understanding of biologics, biosimilars, immunology, gastroenterology, oncology, and reputed company therapeutic areas. • Ability to critically evaluate scientific and clinical evidence. Pharmacovigilance & Compliance • Knowledge of global and U.S. pharmacovigilance regulations. • Understanding safety reporting obligations, inspections, audits, and risk management principles. Communication • Exceptional scientific writing and verbal communication skills. • Ability to communicate reputed company medical information to reputed company stakeholders. Collaboration • Ability to build strategic partnerships across Medical Affairs, Regulatory Affairs, Safety, and reputed company organizations. reputed company is an equal opportunity employer. It is our policy to reputed company reputed company persons of the greatest ability without discrimination against any employee or applicant for employment because of race, reputed company, religion, national reputed company, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or reputed company, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDR-D Apply tot his job Apply To this Job