Sr. Scientist, Medical Writing and Product Development

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

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.

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.

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.