2024-10-09
Technical Writer
Location: Zhejiang
Job Responsibilities:
1. Responsible for drafting and writing various technical documents for the R&D analysis department, such as transfer and validation plans for analysis methods of raw materials and finished products, transfer and validation reports, analysis methods, and quality standards.
2. Responsible for drafting stability research, influencing factor research, forced degradation research, compatibility research, freeze-thaw research plans and reports.
3. Assist in drafting technical documents for the development of formulations, such as formulation process research plans, research summary reports, process trial and pilot batch records, process validation plans and reports.
4. Responsible for drafting laboratory standard operating procedures (SOP), internal guidelines, and other internal management documents.
5. Responsible for drafting CTD format application documents.
6. Responsible for responding to defect declaration letters.
7. Responsible for translating technical documents into English and preparing for international applications.
8. Responsible for managing and updating various technical document templates.
9. Responsible for training on writing technical documents for the R&D department.
10. Responsible for the initial review of technical documents.
2. Responsible for drafting stability research, influencing factor research, forced degradation research, compatibility research, freeze-thaw research plans and reports.
3. Assist in drafting technical documents for the development of formulations, such as formulation process research plans, research summary reports, process trial and pilot batch records, process validation plans and reports.
4. Responsible for drafting laboratory standard operating procedures (SOP), internal guidelines, and other internal management documents.
5. Responsible for drafting CTD format application documents.
6. Responsible for responding to defect declaration letters.
7. Responsible for translating technical documents into English and preparing for international applications.
8. Responsible for managing and updating various technical document templates.
9. Responsible for training on writing technical documents for the R&D department.
10. Responsible for the initial review of technical documents.
Qualifications：
1. Master's degree or above, majoring in pharmacy, chemistry, chemical engineering, biology, medicine, etc.
2. English level 6 or above, proficient in English reading and writing skills.
3. Familiar with domestic and international drug research regulations and guidelines (CDE, FDA, EMA, ICH) and pharmacopoeias of various countries (CP, USP， EP， JP）。
4. More than three years of experience in developing new or generic drugs.
5. Experience in developing and validating analytical methods; Experience in drafting quality standards.
6. Experience in formulation and process development.
7. Experience in writing CTD application materials.
8. Excellent technical writing skills, able to convey complex information clearly and concisely.
9. Pay close attention to details and organizational skills.
10. Able to work independently and collaboratively in a team environment.
11. Proficient in using Microsoft Office Suite and have experience in document management systems.
2. English level 6 or above, proficient in English reading and writing skills.
3. Familiar with domestic and international drug research regulations and guidelines (CDE, FDA, EMA, ICH) and pharmacopoeias of various countries (CP, USP， EP， JP）。
4. More than three years of experience in developing new or generic drugs.
5. Experience in developing and validating analytical methods; Experience in drafting quality standards.
6. Experience in formulation and process development.
7. Experience in writing CTD application materials.
8. Excellent technical writing skills, able to convey complex information clearly and concisely.
9. Pay close attention to details and organizational skills.
10. Able to work independently and collaboratively in a team environment.
11. Proficient in using Microsoft Office Suite and have experience in document management systems.