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
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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