Pragati Kulkarni

1.Lead medical writing activities by drafting and review of various clinical documents that include Clinical Study Protocol, Protocol amendments, CSR, narratives, IND submissions, NDA ARs, DSURs, IB, ICF, Response to Agency Questions, Briefing documents.

2. Adhere to Regulatory standards, including ICH- E3, E2, E6 guidelines as well as company SOP/client approved reference materials.

3. Lead the Regulatory activities like handling of Regulatory submissions and agency correspondences in Veeva Vault.

4. Maintenance and tracking of various timeline milestones for the clinical and marketing applications.

5. Quality Management of the Regulatory and medical writing activities.

6. Calculation and Validation of monthly metrices

7. Conducting technical as well as behavioral training for the team.

8. Interacting with various stakeholders to achieve the effective and timely output of the deliverables.

9. Planning and Execution of pilot projects by defining base SLA and KPIs for the team

10. Review of internal training materials for the teams

1. Drafting and review various clinical documents that include Clinical Study Protocol, Protocol amendments, CSR, narratives, IND submissions, NDA ARs, DSURs, IB, ICF, Response to Agency Questions, Briefing documents.

2. Handling of Regulatory submissions and agency correspondences in Veeva Vault.

3. Updating various timeline milestones in Data Management tool for clinical and marketing applications.

4. Performing publishing activities (such as Proof reading for typo error, hyperlinking, grammar check, data consistency) for the Regulatory Submissions

5. Submitting the submission to FDA via e-Submission Gateway.

6. Managing and Execution of Labeling Artworks

7. Process Trainer for the new hires and employees returning from long leaves

8. Key Trainer for the General Regulatory Affairs training in the life science domain of the organization.

1. Verification of the site credentials before permitting the site for conducting the clinical trials. Triggering the drug shipment to the clinical trial site via electronic drug shipment portal.

2. Ensure that regulatory submissions are made on time and meet sponsor’s corporate and local regulatory requirements.