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Document Coordinator

1.00 to 3.00 Years   Bangalore   09 Sep, 2022
Merck Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other SoftwareDocumentation / Shipping
EmploymentTypeFull-time

Job Description

    A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 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
    Who you are:
    • Graduate or post graduate degree in BPharm/MPharm, PHD, BDS (Dental), BSC/MSC or equivalent job experience with comprehensive Medical W riting 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 Regulatorydocuments
    • Pharmaceutical industry experience (2-5 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 changesA career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.,

Keyskills :
adobe creative suiteama stylestudy reportsspoken englishmedical writingclinical practicescontinuous improvementwritingenglishscienceshapingclinicalbriefinginvestigator brochurectd

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