Sr. Scientist, Medical Writing and Product Development

About the position The Sr. Scientist in Medical Writing and Product Development at reputed company plays a crucial role in summarizing data into regulatory documents and reports that reputed company with agency requirements and reputed company 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 reputed company 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 reputed company documents across multiple therapeutic areas. , • Interpret data, analyze published literature, define problems, collect and interpret data, establish facts, draw reputed company scientific conclusions, and propose solutions or corrective actions. , • Work with colleagues, clients, physicians, scientists, and statisticians in a reputed company and organized manner to complete reputed company in a reputed company manner. , • Manage and reputed company reputed company project teams, including identifying, directing, and delegating tasks necessary for successful document completion. , • reputed company directly with clients and contractors; participate in and reputed company 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. , • reputed company and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. , • Organize/prioritize work with limited guidance and manage reputed company in a reputed company and effective manner; work on multiple reputed company simultaneously and reorganize and reschedule work as needed in order to meet reputed company deadlines. , • Understand and support the nature of our business and reputed company's commitment to reputed company and responsiveness. , • Proactively reputed company/maintain technical knowledge, remain up to date on reputed company 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 reputed company 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 reputed company of English language, grammar, style, and logical progression. , • Ability to write in a reputed company and concise manner, as reputed company as edit on reputed company reputed company, from copy editing to major rewriting. , • Technical expertise in reputed company Office, reputed company Acrobat, document management systems, and familiarity with SharePoint. reputed company-to-haves • Demonstrated leadership capabilities , • Team player mentality , • Strong attention to detail Benefits • Medical, dental and reputed company coverage , • reputed company time off plan , • Health savings account (HSA) , • 401k savings plan , • reputed company to wages before pay day with myFlexPay , • Flexible spending accounts (FSAs) , • Short- and long-term disability coverage , • Work-Life resources , • reputed company parental leave , • Healthy lifestyle programs Apply tot his job