Senior Medical Writer

Role & responsibilities

Authoring and coordinating end-to-end process for preparation, review, approval and distribution of clinical regulatory documents, including Protocols, Investigational New Drug (IND).

Application, Clinical Trial Application (CTA), Clinical Study Reports (CSRs), Clinical Overview and Summaries associated with the assigned products in accordance with worldwide regulatory requirements.

Provides basic-level oversight and guidance for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.

Preferred candidate profile

M. Pharm

• Postgraduation in Lifesciences
• At least 6 years of experience in Regulatory Medical Writing. Candidate must have exposure to EU and the US markets.

Notice Period : Immediate to 30 days preferred

Email : monisha.lahiri@randstad,in