As an Associate Scientific Director in the Medical Communications team you will be responsible to:
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 including protocols, investigator brochures (IBs), clinical study reports (CSRs), periodic safety update reports (PSURs), aggregate reports, risk management plans (RMPs), summary of clinical efficacy (SCE), summary of clinical safety (SCS), and clinical overview (CO) across therapeutic areas.
Qualification: MBBS/MD or PhD (preferably in the pharmaceutical sciences) with knowledge of clinical research
At least 5-8 years of core regulatory writing experience in a medical writing team of a pharmaceutical company or a clinical research organization
Advanced knowledge of clinical research processes and drug development, as well as ICH, GCP, and other such industry guidelines
Hands-on writing experience across study phases, document types, and therapeutic areas/diseases/drug classes
Prior experience with CERs or medical devices, or ability to come up to speed quickly on these projects