Narrative Medical Writing Role

Responsibilities :

1. As per process requirement and assigned primary responsibility, support narratives (draft and QC)

2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards

3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category

4. Conduct and attend narrative kick-off meeting with client to understand the project requirements such as scope of the project, narrative writing plan, narrative categorization.

5. Prepare guidance / convention document for drafting narratives in accordance with the client requirements that must be followed by the team members for consistency within narrative project.

6. Conduct and attend comment resolution meetings with the Clinical lead / safety scientist to seek comment clarification and provide probable solution for conflicting comments.

7. Perform scientific review of the narratives drafted and QCed by the team.

8. Perform tracking of large volume of narratives through narrative tracking sheet to understand process stage of the narrative and provide allocations to the team.

9. Mentoring and coaching the junior writers on their tasks in completing and finalizing their narrative writing deliverables with the defined quality and timeline.

10. Initiate and implement process improvement projects

11. Complete assigned (TCS / Client) trainings within stipulated timelines

12. Provide timely data (study tracker, quality metrics, billing numbers / effort hours) forpreparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the TCS / client requirements

13. Conduct knowledge sharing sessions based on acquired knowledge for team excellence and process improvement

Skills Required

Quality Check, TAT, Tracking