19/10 Diksha Sapra

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THB - Lead Regulatory Writer - Medical Writing (8-15 yrs)

Anywhere in India/Multiple Locations Job Code: 23342

Role :

You will supervise and prepare, edit, refine, and modify regulatory medical writing documents of phase 3, phase 4 and real world clinical studies. Additionally, collaborating and independently coordinating with various internal stakeholders and clients. Responsible for client and project management and acting as client SPoC for clinical studies.

Duties :

- Regulatory Medical writing - Regulatory, Clinical trial related documents, including clinical study protocols, CSRs, clinical overviews

- Study related plans (such as safety monitoring, risk mitigation plan),

- Additionally, you may be asked to work on SAR, and manuscript development

- Possess an in depth understanding of regulatory guidelines, emerging developments, and applications in the medical research domain

- Areas of expertise to include project management and client engagement

- Excellent verbal and written communication skills

Experience : 6 to 10 years of regulatory medical writing experience in phase 3 and 4 clinical studies

Knowledge and Skills :

- Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, and ICH Guidelines

- Extensive experience working with pharma clients and knowledge of clinical studies

- Highly organized and detail-oriented with effective project planning and time management skills

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