Openings for Senior Manager - Medical Writing @ Hospira
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
Skills/Experience Education/Certification 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.
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