Merck KGaA

Principal Medical Writer 1

Posted On

Sept. 3, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time, part-time possible

Apply By

Sept. 24, 2024

Job Description

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. Who you areBachelor’s degree in a scientific or writing discipline required; Master’s degree or Ph.D. preferred.5 to 8 years of regulatory medical writing experience, with a focus on post-marketing (non-) interventional studies.Demonstrated ability to lead medical writing activities, including overseeing vendor resources and coordinating teams within a matrix organization.Strong project management skills with proven ability to handle up to 50% project management responsibilities, ensuring efficient timeline and resource management.Extensive knowledge of regulatory requirements and industry standards in medical writing, combined with proficiency in Microsoft Office and electronic document management systems.Excellent verbal and written communication skills in English, essential for clear and effective collaboration and documentation.Demonstrates a strong commitment to innovation, integrity, and excellence, along with a dedication to continuous improvement and adherence to ethical practices.

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