For over four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology, and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on your research investments. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle to help ensure the continued success of your product post-approval.
The medical writers at Cardinal Health Specialty Solutions summarize data into concise and accurate reports in formats that comply with regulatory agency requirements and client expectations. We author all types of regulatory and nonregulatory documents, including eCTD summary documents, clinical study reports, patient narratives, clinical study protocols, manuscripts, Investigator Brochures, and briefing books, among others.
- Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically-oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, agency RTQs, and eCTD summary documents for IND, NDA, MAA, BLA and biosimilar BLA applications and amendments.
- Interpret data, search and 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.
- Collaborate and help other medical writers in the writing, editing, QC review 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.
- PhD, PharmD, MS, BS, RN, or RPh in a relevant scientific or pharmaceutical discipline.
- 8 years (minimum) of experience in pharmaceutical industry with 5 years (minimum) of experience in medical/regulatory writing/editing. Experience with biosimilars and BLAs preferred.
- Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding of medical terminology and statistical methodology is a must.
- Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy.
- Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as edit on all levels, from copy editing to major rewriting.
- Experience and proficiency with document templates and proper version control.
- Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail.
- This is a remote, work from home position.