Cardinal Health Principal Scientist, Medical Writing in Raleigh, North Carolina
What is expected of you and others at this level in Research for functional success
- Lead the compilation, writing, and editing of high-quality regulatory documents and reports, including CSRs, IBs, safety narratives, safety reports, ISS, ISE, agency RTQs, and eCTD summary documents for biosimilar BLA applications.
- 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 heath authority questions and requests.
- Willingness to 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; leverage expertise to produce solutions that enable global consistency and standardization to ensure exceptional performance.
- Bachelor’s degree or equivalent combination and 8+ years of relevant work experience, or
- Masters and 6+ years of relevant experience, or
- Doctorate and 5+ years of relevant experience;
- 10+ (15 preferred) years of experience in writing clinical and regulatory documents in all phases of regulatory submissions (clinical trial applications to ICH marketing applications);
- Experience with writing clinical and regulatory documents in Regulatory Affairs, Research, Development, or related area in the Biotech/Pharmaceutical industry;
- Experience with biosimilars and BLAs preferred;
- Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment;
- Experience in understanding and interpreting data/information and its practical application;
- Advanced knowledge of scientific/technical writing and editing;
- Organizational expert within defined subject area;
- Excellent written and oral communication; and strong time and project management skills