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:

Briefing Packages: Draft Pre-IND, Pre-NDA briefing packages, SAM briefing packages, orphan drug designation feasibility reports, and expedite approval processes.
Document Support: Review and support clinical trial-related documents (e.g., SAP, Mock TLFs, eCRF outlines, study-specific documents).

Medical Writing Coordination:

Medical Writing Activities: Manage medical writing activities for individual studies, coordinating with departments with minimal supervision.
Content Creation: Develop impactful and accurate content for various deliverables for clients, adhering to client expectations and deadlines through teamwork and scientific expertise.

Compliance and Interaction:

Regulatory Compliance: Ensure all documentation complies with internal standards and external regulatory guidelines.
Cross-functional Interaction: Collaborate with department heads and staff members in data management, biostatistics, regulatory affairs, and medical leads to create writing deliverables.

Administrative Responsibilities:

Department Management: Handle administrative tasks related to the medical writing department, ensuring efficient operation and support.

Desirable Skills and Experience:

Experience: Minimum of 10+ years as a professional medical writer with extensive experience in drafting and managing regulatory medical writing documents.
Regulatory Knowledge: Expert understanding of regulations, policies, and guidelines applicable to regulatory medical writing.
Technical Proficiency: Proficient in Word, PowerPoint, Excel, and Adobe Acrobat, with advanced knowledge of PDF editing and compilation tools.
Publication Knowledge: Basic understanding of the publication process and congress activities.
Communication Skills: Excellent interpersonal and communication skills for effective liaison with internal teams, clients, KOLs, and other key stakeholders.
Attention to Detail: Keen eye for accuracy and high fluency in English.
Work Ethic: Ability to multitask, prioritize effectively, and work collaboratively within a cross-functional team.

Assistant Manager -Medical and Scientific Affairs