Gayathri Vyshalini

Submission Specialist @Prose on Pixels

IN

Responsible for annotating, review and submission of drug promotional content and materials to the regulatory authority and boards as required. Support on the OPDP label submissions and updates.Responsible for project management support and to ensure the end-to-end effective project delivery of the designated MLR submissions.Support the team with the development of a scope of work; build plan and schedule for agreement with the internal stakeholders.Support required submission, compliance, approval with medical annotations/MLR processes and update as required with approval/compliance tools (e.g, Veeva PromoMats, DAM).Support on DAM migration and transition involving retrospective asset management.Support the management of MLR submission process and annotation team in line with the agreed budget. Collaborate effectively with stakeholders: medical content enhancement teams, medical writing teams and medical communications.Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical annotations group. Secure adherence to compliance procedures and internal/operational risk controls in accordance with all applicable regulatory standards.

O.P. Jindal Global University (JGU)

Master of Business Administration - MBA

Sri Chaitanya Junior College

+2

Bharat Institute of Engineering & Technology

Doctor of Pharmacy - PharmD

Sujatha High School - India

Secondary school of education