The Associate Director, Medical Information and Review works closely with the Head of Global Medical Affairs Excellence to lead a high performing team responsible for medical information and medical review activities across Deciphera’s portfolio. This individual is responsible for providing high-quality, timely, balanced and up-to-date medical and scientific information to internal and external customers, globally. The Associate Director is responsible for the management of Medical Review personnel providing the medical and scientific accuracy review of promotional and non-promotional materials across the portfolio. As necessary, this individual may support broader activities within Global Medical Affairs. The employee carries out this role in accordance with departmental SOPs, corporate policy, and other legal and regulatory requirements.Key Responsibilities
Management of the Medical Information function Responsible for the creation, review, and approval of standard response letters (SRLs), FAQs, and other scientific materialsEnsures scientific accuracy, compliance, and alignment with product labeling and regulatory requirementsOversight of the third-party contact center as it relates to: Compliance with workflow procedures and standards; Inquiries requiring escalation or customization; Conducting quality review of medical information cases and responses to ensure consistency and accuracy; New hire or ongoing therapeutic area/product training, as applicablePerform critical analysis of medical inquiry trends to identify key insights, develop evidence-based conclusions, and provide actionable recommendations that inform Global Medical Affairs strategic plansLead medical information launch planning and execution for new products and indication expansionEnsure all medical information activities comply with applicable laws, regulations, and industry standards (e.g., PhRMA, FDA, EMA)Participate in internal audits and regulatory health authority inspections as neededProvide conference support including staffing the medical information booth and covering scientific sessions as neededImplementation of medical information best practices Supports various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; identification of new innovative opportunities for dissemination of medical information. Medical Review Process Oversee personnel tasked with ensuring medical accuracy of Deciphera’s advertising, promotional and scientific materials as part of Promotional Material Review Committee (PMRC) and Medical Material Review Committee (MMRC), in collaboration with the Medical Affairs Medical DirectorsEnsure team is providing fact-checking of data points and verification that all claims and statements are adequately supported by appropriate references and properly cited in materials submitted to the PMRC/MMRC in a timely mannerOther duties and responsibilities as assigned.
