Hospira – A Pfizer Company Hiring Life Science candidates For Executive – Technical Writing Post

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

Click to Apply Online