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Hospira – A Pfizer Company Hiring Life Science candidates For Executive – Technical Writing Post
Hospira is the world’s leading provider of inject-able 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.
Job Title : Sr Executive / Executive – Technical Writing
Experience : 1 – 5 Years
Eligiblity : B.Tech/B.E/ M.tech – Bio-Chemistry / Bio-Technology / Microbiology
Location : Chennai
Role Description : Responsible for writing drug safety related documents. (experience in Bio Similar are Preferred )
Major Duties & 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.
Desired Profile:
- 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 1 year 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.
- Post-graduate training in a health related field and / or equivalent experience is desirable.
- Advanced/well-developed skills and knowledge within a specific professional discipline involving the integration of theory and principles with organizational practices and precedents
