Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.
Post: Senior Manager - Medical Writing
Job Description
PRIMARY FUNCTION:
- Responsible for writing drug safety related documents.
MAJOR DUTIES AND RESPONSIBILITIES:
- Research, write and edit Drug Risk Management Plans (RMPs).
- Research, write and edit Drug Safety aggregate reports, such as PSURs, PBRERs, CASRs.
- Write Individual Case Safety Reports, Subject narratives (of significant adverse events)
- Ensure full quality assurance and quality control procedures are followed for all documents written
- Conduct peer reviews and quality checks for other writers
-Plan, coordinate and track the progress of the medical writing activities with other stake holders like medical monitors, clinical project managers, etc
- Train and mentor junior writers
- Prepare Standard Operating Procedures (SOPs) and templates
Qualification and Experience:
- Experience of 1-2 years in writing Drug Risk Management Plans for generic drugs.
- Experienced in writing Drug Safety aggregate reports, such as PSURs, PBRERs, CASRs.
- Skilled in writing Individual Case Safety Reports, Subject narratives (of significant adverse events).
- Minimum of 5 years’ experience working within the pharmaceutical industry (Biotech, pharmaceutical or clinical research organization).
- Knowledge of global Drug Safety regulatory requirements with a strong focus on US, EU, ICH requirements.
- Attention to detail with the ability to manage multiple projects.
- Ability to manage multiple stakeholders.
- Good oral and written skills.
- Demonstrated team player with a positive attitude.
Additional Information:
Experience: 1-2 Years
Auto req ID: 20999BR
Location: Chennai, Tamil Nadu
Functional Area: R&D
Job Type: Salaried
End Date: 28th April, 2016
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