Company Jobs

Prepare, compile and review regulatory submissions for ROW markets. Prepare CTD/ACTD dossiers for non-regulated markets.  Ensure timely dossier submissions and respond to regulatory queries. 

Good communication and analytical skills. Team player with the ability to complete tasks in a timely manner.

Troubleshoot instrument-related issues and malfunctions and coordinate for resolution wherever required. Prepare and review SOPs, protocols, worksheets and other applicable documentation in accordance with GLP and established SOP requirements.

To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.

Responsible for preparation and review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. 

Ensure assigned products remain in a validated and compliant state as per MS&T and regulatory expectations. Contribute to investigations and prepare OPV reports, PPQ documentation, regulatory responses, and scale up proposals.

Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff.

Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content

MBBS/M.D., Ph.D., or Pharm.D. required, with an M.D. highly preferred; subspecialty training and/or Real-World Evidence (RWE) experience is advantageous.