Part-Time Medical Writer - #1169444

SUMMARY

On Dot Target Molecules Biotech PTE LTD, Singapore, is a subsidiary of On Dot Target Molecules Biotech Inc, USA. The Company operates a research and development laboratory at Gemini, Science Park, Singapore.

Academic Qualifications

• PhD in Bio-Chemistry, Biotechnology

Skills

• Drafting manuscripts for IND readiness FIH clinicals.
• Preparing data reports on the potency, safety and quality attributes of pre-clinical data.
• Broad expertise to deliver our project successfully with clear scientific writing.
• Knowledge of Nanotherapeutics, cell culture, omics and CMC are a must.

Work Experience (3 to 5 Years)

• Cell and Gene Therapy – Research and GMP Production
• Legal Compliance and IND Submissions
• Writing and Adopting SOPs
• Auditing of Quality Control of Formulations

Core Responsibilities

• Write reports that meet necessary scientific, technical, and regulatory requirements for submission to various regulatory bodies.
• Audit Trial for all materials for formulation studies, manufacturing, and QC tests.
• Due diligence in operations, processes, and protocols.
• Assisting scientists and operations team in adopting and fulfilling best practices.

Database Experience: Benchling

Laboratory Roles and Responsibilities

• Perform assigned tasks from the CSO in a time efficient manner.
• Collect experiment data, records, and analysis, for regulatory reporting and submissions.
• Be involved and contribute to the development of protocols and technical reports.
• Assist in laboratory and administrative work.

Timings

• 9AM to noon – Monday, Wednesday, and Friday
• $50 SGD an hour