Medical Affairs Documentation Specialist

Medical Affairs Writer JD

1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards.

2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan.

3. Collaborating across line functions in preparing SOPs for Regulatory documents.

4. Interpreting, representing and summarizing clinical and scientific data

5. Planning, organizing, tracking, and archiving clinical and post-marketing regulatory dossiers.

6. Managing stakeholders across line functions and geographies.

7. Managing assigned individual projects and holding complete responsibility throughout the document / project lifecycle.

8. Ensuring consistency at all times with compulsory and voluntary codes of conduct, appropriate legislations and compliance with internal SOPs.

• 9. Building-up newer competencies and enhance existing competencies;

analyzing skill / processgaps and bridging the gaps by developing expertise / process maps.

10. Developing cross-functional skills in publication writing.

11. Training peers in regulatory writing.

12. Mentoring and coaching of direct reportees, if any