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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 non‑regulatory documents, including eCTD summary documents, clinical study reports, patient narratives, clinical study protocols, manuscripts, Investigator Brochures, and briefing books, among others.
- 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.
- 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.
Qualification & Experience:
- 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.
Company: Cardinal Health
Vacancy Type: Full Time
Job Location: Houston, TX, US
Application Deadline: N/A