• Mentors and leads less experienced medical writers on complex projects, as necessary. • Acts as lead for assigned med info writing projects. • Manages and coordinates medical information activities within and across departments with minimal supervision. • Responds to escalated queries from client internal and external teams (HCPs, patients, caregivers). • Create or update an existent global standard scientific response communications (gSSRCs)/FAQs/global response documents/global guidance documents/local response documents based on client provided template or as per style guide. • Conducts literature search on PubMed, and/or other client-subscribed databases; and validate relevant inclusions. • Experience in developing or supporting a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations. • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. • Serves as peer reviewer on internal review team providing review comments on draft and final documents. • Adheres to established regulatory standards, including but not limited to Journal/congress specific guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.

• Review patient medical records (charts) for completeness, accuracy, and compliance with ICD-10-CM coding guidelines and CMS risk adjustment criteria. • Identify documentation gaps or opportunities that impact HCC capture and risk scores. • Utilize AI-enabled CDI platforms, electronic health records (EHR), and data dashboards to analyze trends, prioritize chart reviews, and flag discrepancies. • Work closely with primary care providers, specialists, and other clinical staff to clarify documentation and educate on best practices, when required. • Collaborate with coding, billing, compliance, and analytics teams to align goals and implement CDI strategies, when required. • Support the execution of cross-functional projects aimed at improving data integrity, documentation quality, and risk adjustment outcomes. • Maintain accurate tracking and reporting of CDI queries, provider responses, and documentation improvements in designated systems or databases. • Stay up to date on current CMS guidelines, ICD-10-CM updates, HCC risk adjustment models (CMS-HCC, RxHCC), and relevant healthcare regulations.

• Mentors and leads less experienced medical writers on complex projects, as necessary. • Acts as lead for assigned writing projects. • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. • Develops or supports a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations. • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. • Serves as peer reviewer on internal review team providing review comments on draft and final documents. • Adheres to established regulatory standards, including but not limited to Journal/congress specific guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. • Performs on-line clinical literature searches, as applicable. • Familiarity with figure-creation and data visualization software, including tools such as GraphPad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics. • Familiarity with publication planning software e.g. Datavision and PubConnect (VeevaVault Promomats) • Reviews deliverables for scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets. • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing. • Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. • Completes required administrated tasks within the specified timeframes. • Performs other work-related duties as assigned. • Minimal travel may be required (less than 25%).

Role Description 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: - Safety Medical Writing and Safety Analysis - Aggregate Safety Reports & Documentation: - Leads or contributes independently, with supervision, to the preparation and compilation of both scheduled and ad-hoc aggregate safety reports, including: - Periodic Safety Update Reports (PSURs) - Periodic Benefit Risk Evaluation Reports (PBRERs) - Addendum to Clinical Overviews (ACOs) - Development Safety Update Reports (DSURs) - Periodic Adverse Drug Experience Reports (PADERs) - Semi-Annual Safety Reports (SASRs) - Annual Risk-Benefit Evaluation (ARBE) report - Responsible for independently leading simple reports and supporting the development of medium complexity reports under guidance. - Incorporates team review feedback into document drafts, ensuring all relevant input is addressed and conducting quality reviews to verify consistency and data integrity across safety reports. - Coordinates the submission process for safety documents to regulatory authorities across multiple regions. - Generates supporting documentation including comparison documents between local and global labeling, INN checking, and appendices. - Safety Analysis & Signal Management: - Independently performs signal detection activities by collecting and analyzing data from various sources (databases, clinical, literature, regulatory websites) in accordance with applicable procedural documents. - Performs both quantitative and qualitative analyses of safety data using established methodologies to identify potential safety signals. - Manages signal tracking activities and maintains comprehensive signal logs with minimal supervision. - Supports safety activities for simple molecules with established profiles, contributing to data interpretation and team discussions. - Assists in preparing signal assessment documents, such as Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs), which summarize data from various sources. - Conducts literature searches and reviews publications to summarize safety data for signal evaluation, PSRs, and epidemiology reports. - Identifies and resolves data discrepancies in line listings and other safety data sources to ensure data integrity. - Risk Management Plan: - Assists in preparing and updating Risk Management Plans (RMPs) and related documents, ensuring accuracy and compliance. - Collaborates with team members to maintain consistency in risk-related documents and communication. - General Scientific Support: - Demonstrates good working knowledge of the safety profiles of assigned products and therapeutic areas. - Demonstrates proficiency in medical terminology and pharmacovigilance coding dictionaries (MedDRA, WHO-DD). - Delivers high-quality outputs through meticulous self-review and effective incorporation of feedback. - Contributes meaningfully to team discussions on safety findings, offering substantive insights based on experience. - Communicates proactively with team members to share updates on task progress, address challenges, and manage timelines effectively. - Effectively prioritizes tasks and consistently meets deadlines. - Maintains audit-ready documentation and ensures proper archiving of source materials and communications. Supports inspection readiness activities as directed by supervisors. - Client Engagement & Collaborative Communication: - Manages client interactions effectively; handles routine queries independently while escalating complex issues; demonstrates cultural sensitivity with global stakeholders. - Delivers proactive status updates; efficiently manages document cycles; adapts to client-specific requirements and templates. - Collaborates seamlessly across functions while demonstrating cultural sensitivity with global stakeholders to deliver integrated, respectful client service. - Quality Control & Compliance Management: - Applies knowledge of global regulatory requirements to ensure timely, high-quality deliverables through robust quality control and oversight of junior team members. - Monitors KPIs and SLAs to support successful project execution and participates in audit readiness activities, contributing to continuous improvement. - Learning and Development: - Completes advanced training and contributes to team efficiency through practical guidance and collaboration. - Innovation & Technology: - Effectively uses tools and systems, adapts to new technologies, and supports process improvements to enhance efficiency and maintain high-quality outputs. Qualifications - Analytical thinking and problem-solving to interpret complex safety data and draw meaningful conclusions. - Scientific writing and communication expertise, with the ability to produce clear, accurate, and compliant documents. - Strong collaboration and interpersonal skills for effective teamwork across cross-functional, global teams and client interactions. - Excellent organizational and time management, with the ability to prioritize tasks, manage multiple projects, and meet deadlines. - Proficiency in medical writing tools and MS Office applications, with familiarity in pharmacovigilance databases and coding dictionaries (e.g., MedDRA, WHO-DD). - Adaptability and continuous learning mindset, with a proactive approach to new technologies and evolving processes. Requirements - Prior experience in pharmacovigilance, or related fields is preferred. - Demonstrates good understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts. Education - Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc. Or equivalent combination of training and work experience. - Clinical exposure in hospital-based environments is considered advantageous.