Key Responsibility:
This role is responsible fediting, updating high-quality clinical regulatory documents following agreed timeline fclinical studies regulatory submissions. Responsibilities also include planning, coordinating driving the development of clinical regulatory documents.
1. Set up the function related SOPs/WIs/templates to meet the company goal HA/regulatory requirement.
2. Develop maintain the function related quality system to meet the business needs.
3. Maintain the training matrix, deliver related training to the company as per requirement.
4. Lead the team to develop documents, such as protocol, IB, Briefing book, CSR etc. per company SOP within the timeline with good quality.
5. Lead the team to develop the medical publication materials fmeetings, journals, within timeline with good quality.
6. Oversee vendselection management ffunction-related vendors.
7. Provide the medical information per CD team needs also proactively share the medical meetings, medical intelligence which will facilitate the medical strategy etc.
8. Report function’s key progress, issues actions regularly to CMO company senimanagement.
9. Other related work as assigned by the company.
Qualifications:
1. Master above; Biology, Medicine, Pharmacy;Physician PhD is preferred
2. At least 5 year experience of medical writing experiences preferred
3. Relevant pharmaceutical industry experience
4. Excellent scientific analytical thinking
5. Microsoft Office Suite proficient (Excel, Outlook, PowerPoint, Word, etc.)
6. Excellent communication skills in English (written verbal)
Traits:
1. Solid problem solving time management skills
2. Great interpersonal skills
3. Strong attention to detail