01Overview
Principal Medical Writer, Patient Safety When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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: Independently lead the preparation/update 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), United States 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) and any other ad hoc safety documents, ensuring scientific accuracy, regulatory compliance, and timely delivery. Serves as an SME for safety reports, developing templates, guiding teams, and creating strategies to address complex regulatory and data presentation challenges. Facilitate operational coordination, including scheduling and leading meetings, drafting agendas and minutes, tracking action items, and ensuring timely follow-up on open issues to support seamless project execution. Ensure compliance and quality across aggregate safety reports, performing detailed reviews for factual accuracy and internal consistency across documents such as but not limited to PBRERs, DSUR etc.). Manage the distribution of final reports to stakeholders, including partners, affiliates, and health authorities, in accordance with agreed timelines, distribution lists, and email templates (as required). Safety Analysis & Signal Management: Leads advanced safety signal detection and management for key products, integrating diverse data sources and innovative analytical approaches to identify emerging safety concerns. Provides expert interpretation of complex safety data patterns and trends across product lifecycles. Leads clinical safety activities for complex molecules, contributing to strategic decisions as part of the global safety team. Collaborates with cross-functional teams to analyze complex safety data and provide support as part of the study management team. Directs literature review strategies and critically evaluates scientific evidence for inclusion in safety documents. Leads safety evaluations for complex molecules and sensitive indications, providing scientific direction that supports clinical strategy and strengthens regulatory positioning through high-quality safety reports and responses. Risk Management Plan: Leads global RMP and Company Core-RMPs (CC-RMP development and updates, ensuring alignment with safety profiles, regulatory standards, and strategic goals. Prepares and reviews regulatory response documents, integrating safety data to support RMP submissions and address authority queries. Provides strategic input on risk minimization and benefit-risk communication, collaborating with cross-functional teams to ensure scientific and regulatory robustness. General Scientific Support: Provides strategic scientific expertise across therapeutic areas, supporting safety documentation and regulatory planning with deep understanding of evolving safety profiles. Drives quality and innovation in documentation standards, process optimization, and cross-functional alignment through proactive planning and oversight. Advises on emerging safety trends, contributing to risk mitigation strategies and representing medical writing in strategic forums and decision-making discussions. Client Engagement & Collaborative Communication Leads strategic client engagement for complex safety projects, driving discussions, negotiating deliverables, and aligning safety and regulatory strategies with client expectations. Build strong cross-functional relationships, ensuring effective communication, resolving escalations, and enhancing client satisfaction through consistent delivery and collaboration. Quality Control & Compliance Management Leads quality oversight for complex safety documents, ensuring scientific accuracy, regulatory compliance, and consistency across global submissions. Drives continuous improvement .
