Merck KGaA
COMW-0 Principal Medical Writer
Job Description
Who you are: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.> 10 years experience in Pharma Industry (with 5 to 8 years of experience in Regulatory medical writing, including experience in postmarketing studies) Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide. Responsibilities :As a Principal Medical Writer you will play a pivotal role in leading the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional/local levels. This includes independently preparing or overseeing the preparation of clinical and regulatory documents such as Protocols, Clinical Study Reports, Investigator Brochures, or Clinical Summary documents. You will also be responsible for supporting submissions for market approval/line extensions under minimal supervision. In this role, you will oversee and coordinate other (external) writers assisting on documents under your responsibility, ensuring strict adherence to business objectives, company standards, as well as the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar.You will represent the department as a subject-matter expert on clinical study teams, leading document-related meetings and reviewing study-related documents. Additionally, you will ensure that all documents are produced according to agreed timelines, adhere to relevant SOPs, and meet the requirements of regulatory authorities and the company.Furthermore, you will play a proactive role in contributing to the development and implementation of Medical Writing best practices and process improvements.
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