Cardinal Health Medical Writer in Kansas
For over four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical and biotechnology companies successfully develop their products and secure marketing approvals. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on clients’ research investments. We provide efficient scientific and regulatory consulting and services throughout the full product lifecycle from early development to post-approval.
The Medical Writers at Cardinal Health Specialty Solutions perform a crucial role. They summarize data into concise and accurate reports in formats that comply with regulatory agency requirements and client expectations. They author all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others.
The Medical Writer assists in 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, BLA and biosimilar BLA applications.
- Assists in 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, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly.
- 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 regulatory documents and reports.
- 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.
- Remote, telecommuter
- Bachelor's degree in related field, or equivalent work experience, preferred
- PhD, PharmD, MS, BS, RN, or RPh in a relevant scientific or pharmaceutical discipline a plus
- 5 years of experience in pharmaceutical industry with 3 years (minimum) of experience in regulatory writing.
- Experience with biosimilars and BLAs a plus.
- 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 to review and edit on all levels, from copy editing to message strengthening to major rewriting.
- Experience and proficiency with document templates, document toolbars and proper version control.
- Demonstrated leadership capability. Good team playercharacteristics.Excellent communication and interpersonal skills. Strong project management skills. Organized andself-motivated.Strong attention to detail.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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We are a team of nearly 48,000 mission-driven partners striving each day to advance healthcare and improve lives. We are Essential to care.
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities
We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.
With 50 years of experience, approximately 44,000 employees and operations in more than 30 countries, Cardinal Health seizes the opportunity to address healthcare’s most complicated challenges — now, and in the future.
On Thursday, Jan. 7, 2021, we celebrated the day our founder, Bob Walter, had the vision to start a business that became known as Cardinal Health.
One of the most important ways we celebrated was by giving back to the communities where we live and work. 2021 was a "Year of Service” for all Cardinal Health employees around the world.
View Cardinal Health on YouTube (http://youtube.com/user/CardinalHealth)
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.