Assistant Manager -Medical and Scientific Affairs

Core Responsibilities :  Clinical Document Management :

• Drafting & Management :   Independently draft and manage clinical documents such as Protocols, Investigators Brochures (IB), Informed Consent Documents (ICD), and other regulatory submission documents (e.g., IND, NDA, BLA, MAA, 505(b)(2), Biosimilar, hybrid applications).
• Preparation & Review :   Prepare and review key regulatory documents including the Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Module 2.6, Module 2.7, and briefing documents. Develop ISS and ISE text summaries.

Regulatory and Strategic Documentation :

Medical Writing Coordination :

Compliance and Interaction :

Administrative Responsibilities :

Desirable Skills and Experience :

Skills Required

Word, Powerpoint, Excel, Adobe Acrobat, Clients