Manager, Regulatory Writing

Manager, Regulatory Writing
Cactus Communications Private Limited - Mumbai

Responsibilities: Build regulatory writing team based on client and business needs Coordinate with the business development team when required to provide technical inputs for RFIs/RFPs/Proposals Track metrics related to efficiency and quality Manage client accounts and projects Ensure timely production of high quality regulatory documents (clinical study reports, investigator brochures, protocols (phase 1-4, periodic safety update reports, etc.) across therapeutic areas Review documents and provide meaningful feedback to medical writers Provide formal or informal coaching to regulatory writers by sharing technical information, giving guidance (e.g., best practices), answering questions, and directing them to the appropriate resources Provide quality-related coaching or mentoring to team members, as appropriate Develop and maintain necessary templates, formats and style guides to ensure that documents generated meet client requirements. For more info visit at mentioned link