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Post : Senior Specialist Document Coordinator
Job Description
About the Role
As a Document Coordinator, you will support the Global Medical Writing Team to deliver its portfolio effectively and efficiently.
Your role would require you to :
• Conduct quality review of clinical and regulatory documents including but not limited to Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, and Clinical Summary documents.
• Ability to work within a team in collaborative and supportive role Mentor and train the assigned new joiners/junior Document coordinators
• Participate in meetings related to key MW, QC, and compliance activities
• Collaborate cross functionally for continuous improvement of for medical writing
Candidate Profile
• Graduate or post graduate degree in BPharm/MPharm, PHD, BDS (Dental), BSC/MSC or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
• Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
• Knowledge of Clinical and Regulatory documents
• Pharmaceutical industry experience (4-7 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge) required.
• Knowledge of ICH/Good Clinical Practices, CTD guidance.
• A flexible attitude with respect to work assignments and new learning; readily adapt to changes
Additional Information
Experience : 4-7 years
Qualification : BPharm/MPharm, PHD, BDS (Dental), BSC/MSC
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th May 2025
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