Job Description
ABOUT THIS ROLE Key Accountabilities: Note: The below statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable. Safety Medical Writing and Safety Analysis Aggregate Safety Reports & Documentation: Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) Develops strategic approaches for challenging safety submissions, incorporating innovative data presentation techniques to enhance clarity and regulatory impact. Reviews and approves high-complexity safety documents, ensuring scientific accuracy, regulatory compliance, and alignment with product strategy. Coordinates multi-document submissions, ensuring consistency and integration across safety documentation packages. Provides expert guidance on evolving global regulatory requirements and advises on their implications for safety documentation. Manages meeting logistics including scheduling, agenda drafting, minute preparation, and tracking of action items, ensuring timely follow-up and resolution of open issues. Safety Analysis & Signal Management: Designs and implements advanced signal detection plans tailored to specific product profiles and diverse data sources. Leads signal detection for priority products by conducting expert-level analyses to uncover subtle safety signals and complex data patterns. Develops robust literature review strategies and critically evaluates complex scientific evidence or inclusion in PSRs, drug safety reports, and RMPs. Supports clinical safety and ad-hoc safety activities for complex molecules, contributing to strategic safety evaluations. Authors and reviews high-priority signal assessment reports and health authority response documents, resolves data challenges, and enhances decision-making through expert analysis and innovative visualizations. Risk Management Plan: Leads the preparation, updating, and integration of Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs) across multiple regulatory regions and product types, ensuring alignment with evolving safety profiles and strategic objectives. Prepares and handles reviews of health authority response documents, incorporating safety data and regulatory insights to address queries and support submissions of RMPs. Oversees Reference member state (RMS) updates, ensuring consistency with client conventions, global regulatory expectations, and internal SOPs. Provides strategic input on risk minimization measures and benefit-risk communication, tailoring content to diverse regulatory audiences. Collaborates with cross-functional teams to ensure RMPs are scientifically robust, compliant, and aligned with the overall safety strategy. General Scientific Support: Demonstrates deep expertise in safety profiles across a wide range of therapeutic areas and product types, applying advanced scientific judgment to support safety documentation and strategy. Ensures exceptional quality through proactive planning, comprehensive oversight, and continuous improvement of documentation standards and processes. Provides authoritative input to safety strategy discussions and regulatory planning, and cross-functional decision-making forums. Represents medical writing in strategic planning meetings, contributing to cross-functional alignment Develops and implements innovative solutions for documentation management, quality assurance, and process optimization. Advises on therapeutic area trends and emerging safety concerns, supporting proactive risk mitigation and strategic planning. Client Engagement & Communication Leads high-impact client meetings and serves as a strategic advisor on safety documentation, acting as the primary contact for high-priority projects and fostering long-term partnerships. Collaborates with clients to define project scope, timelines, and deliverables, ensuring optimal use of resources while maintaining high quality standards. Develops clear, client-focused communication strategies and effectively manages stakeholder relationships to resolve issues and drive collaboration. Quality Control & Compliance Management Provides strategic guidance on evolving regulatory requirements and ensures their effective implementation across projects. Designs and manages quality systems to ensure consistency and compliance, resolving systemic quality issues through targeted, sustainable solutions. Manages KPIs and SLAs, optimizing resource allocation to meet performance targets. Leads audit readiness for safety documents, ensuring compliance and effective external representation. Team Leadership Leads complex safety writing across multiple products, managing timelines, mentoring teams, ensuring scientific and regulatory quality, and supporting strategic initiatives including client engagement, business development, and internal knowledge sharing. Training & Team Development Designs and delivers advanced training programs, educational resources, and reference materials to enhance team expertise in safety writing. Mentor junior and mid-level writers, offering guidance on complex scientific and regulatory concepts and supporting career development. Identifies skill gaps and recommends targeted development opportunities to strengthen team capabilities. Supports recruitment and onboarding, contributing to team growth and integration. Innovation & Technology Drives innovation and efficiency in safety writing through implementation of innovative solutions, process improvements, and knowledge sharing.
