Sr. Scientist, Medical Writing and Product Development

About the position The Sr. Scientist in Medical Writing and Product Development at Cardinal Health plays a crucial role in summarizing data into regulatory documents and reports that comply with agency requirements and client expectations. This position involves authoring various regulatory and non-regulatory documents, ensuring the successful navigation of products through the regulatory landscape, and contributing to the overall success of pharmaceutical and biotechnology products post-approval. Responsibilities • Compile, write, and edit regulatory documents and reports, including clinical study protocols, CSRs, IBs, safety narratives, and sections of CTD/eCTD summary documents across multiple therapeutic areas. , • Interpret data, analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions. , • Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner. , • Manage and direct client project teams, including identifying, directing, and delegating tasks necessary for successful document completion. , • Interact directly with clients and contractors; participate in and lead discussions during meetings. , • Collaborate with project teams to respond to health authority questions and requests. , • Mentor and help other medical writers in the writing, editing, and compilation of documents. , • Prepare and manage project plans and timelines. , • Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. , • Organize/prioritize work with limited guidance and manage projects in a timely and effective manner; work on multiple projects simultaneously and reorganize and reschedule work as needed in order to meet client deadlines. , • Understand and support the nature of our business and our company's commitment to quality and responsiveness. , • Proactively develop/maintain technical knowledge, remain up to date on current trends and best practices. Requirements • PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline, preferred. , • 5+ years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry, preferred. , • Ability to prepare any type of clinical regulatory document without supervision according to company guidelines and international governmental regulations. , • Excellent oral and written communication, and project management skills. , • Strong understanding of drug development, clinical study design, regulations (CFR, FDA, and ICH guidelines), and scientific principles. , • Understanding of medical terminology and statistical methodology is a must. , • Experience writing clinical protocols, clinical study reports, and CTD/eCTD summaries. , • Strong command of English language, grammar, style, and logical progression. , • Ability to write in a clear and concise manner, as well as edit on all levels, from copy editing to major rewriting. , • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint. Nice-to-haves • Demonstrated leadership capabilities , • Team player mentality , • Strong attention to detail Benefits • Medical, dental and vision coverage , • Paid time off plan , • Health savings account (HSA) , • 401k savings plan , • Access to wages before pay day with myFlexPay , • Flexible spending accounts (FSAs) , • Short- and long-term disability coverage , • Work-Life resources , • Paid parental leave , • Healthy lifestyle programs Apply tot his job