Authoring and coordinating end-to-end process for preparation, review, approval and distribution of clinical regulatory documents, including Protocols, Investigational Current 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.
Education
M. Pharm
Postgraduation in Lifesciences or equivalent
PhD. is preferable
Minimum Work Experience
At least 6 years of experience in Regulatory Medical Writing. Candidate must have exposure to EU and the US markets
📌 Senior Medical Writer Chandigarh
🏢 IT
📍 Chandigarh
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.