Medical Writer

작업 내용

• Ensure that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles.
• Perform product evaluation, regulatory strategy and gap analysis, as well as protocol design and development.
• Responsible for CSR, clinical investigator’s brochure, CTD, submission e.g. IND, NDA …, integrated report, annual update, and special science report writing.
• Demonstrate a strong ability in scientific literature search, review, and information integration.
• Complete other tasks or assignments requested by the director.
  
  

• At a minimum of master degree of life science / pharmacy / nursing / medical /health related science or equivalent; PhD/PharmD in life sciences preferred.
• Required working experiences: biotech or pharma for 3 years. Experience with regulatory requirements for various types of clinical document writing, preparation, or review.
• Well understandings for medical/ clinical terms.
• Adequate scientific logic and basic statistic concepts.
• Excellent English writing and presentation, listening, communication skills.
• Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment.
• Willing to receive training and develop career in medical scientific field.