Medical Writer (Contractor)

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Medical Writer (Contractor) based in the United States. As a Medical Writer, you will contribute to the development and maintenance of high-quality clinical and drug safety documentation supporting pharmaceutical product development and post-marketing surveillance. You will analyze clinical and non-clinical safety data, prepare regulatory reports, and help ensure compliance with global pharmacovigilance requirements. Working alongside drug safety professionals, clinical research teams, and regulatory specialists, you will play an important role in protecting patient safety and supporting informed regulatory decisions. This contract opportunity offers exposure to diverse therapeutic areas and a variety of medical and regulatory documents. You will also contribute scientific expertise to signal assessment, risk management, and safety reporting activities. Ideal for a detail-oriented medical writing professional, this role combines scientific rigor, regulatory knowledge, and cross-functional collaboration in a technology-enabled life sciences environment. Accountabilities: - Analyze and interpret safety data: Review clinical and non-clinical safety data, alongside relevant scientific sources, to support accurate, evidence-based pharmacovigilance documentation and regulatory submissions. - Prepare aggregate safety reports: Author and review periodic and development safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Canadian annual reports, safety update reports, and addenda to clinical overviews.

- Develop risk management documentation: Prepare and review Risk Management Plans (RMPs) and related documents to support the assessment, communication, and mitigation of potential product safety risks. - Author clinical and regulatory documents: Develop and review Clinical Study Reports, clinical study protocols, labeling documents, and other materials supporting clinical development, regulatory submissions, and post-marketing product maintenance. - Conduct signal detection and assessment: Perform qualitative and quantitative signal assessments to identify, evaluate, and communicate potential safety concerns associated with medicinal products. - Conduct scientific literature reviews: Search, assess, and summarize relevant scientific publications, incorporating appropriate evidence into aggregate reports and other pharmacovigilance deliverables. - Support safety reporting operations: Generate Periodic Safety Line Listings (PSLLs) from safety databases and maintain accurate process trackers, ensuring effective documentation management and reconciliation. - Coordinate regulatory and safety communications: Collaborate with Regulatory Affairs and other stakeholders to support appropriate reporting of drug safety information to health authorities and the prescribing community. - Respond to regulatory inquiries: Contribute to responses to regulatory agency questions and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, providing clear, accurate, and scientifically supported information. - Ensure quality and timely delivery: Verify that all client deliverables meet applicable regulatory requirements, internal quality standards, and agreed project timelines. - Provide subject matter expertise: Serve as a medical writing and pharmacovigilance resource, offering guidance, training, and mentoring to colleagues and pharmacovigilance associates. - Support evolving business needs: Contribute to high-priority ad hoc assignments, adapt to changing project requirements, and collaborate effectively with clinical research organizations (CROs), partner teams, and other stakeholders.