Merck KGaA
Senior Specialist Document Coordinator
Job Description
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 coordinatorsParticipate in meetings related to key MW, QC, and compliance activitiesCollaborate cross functionally for continuous improvement of for medical writing Who you are:Minimum Requirements: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 RegulatorydocumentsPharmaceutical 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
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