job title:senior specialist/expert medical writer(merck)

Title: Senior Specialist/ Expert Medical writer

Location: Bangalore

About the Role

As a Senior Specialist/ Expert Medical writer , you will support the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional/local levels.

• Independently prepares of clinical and regulatory documents such as Protocols, Clinical Study Reports, or Investigator Brochures.

• You will also be responsible for supporting submissions for market approval/line extensions under minimal supervision.

• Proactively contribute to the development and implementation of MW best practices and process improvements.

• May 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.

• Ensure that all documents are produced according to agreed timelines, adhere to relevant SOPs, and meet the requirements of regulatory authorities and the company.

• Participate in meetings related to key MW, QC, and compliance activities.

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.

• Regulatory medical writing experience (4 to 9 years)

• Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.

• Knowledge of Clinical and Regulatory documents