job title: Sr specialist document coordinator(Merck)

Roles and Responsibilities

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:

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 Regulatorydocuments

• 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