Taiwan Life Science Medical Writer
Proclinical is currently recruiting for a Taiwan Experienced Life Science Medical Writer with a global biopharmaceutical company located remotely. You will author complex regulatory documents ensuring the coordination and integration of the scientific, medical and regulatory input from development team members and to support the performance goals for filing regulatory dossiers as planned by the Development Teams.
- Must be able to work cross-functionally to produce high-quality, accurate documents within appropriate timeframes
- Manage timelines and communicate with team members to maintain awareness of milestones, and deliverables
- Confirm clinical documents adhere to company standards and regulatory guidelines
- Confirm that assigned documents undergo a quality check before approval
- Confirm the key messages as defined by the team are clearly and adequately represented in the documents; drive the team to reach agreement in case of conflicting opinions.
- Establish effective cross-functional communication and relationships with counterparts both internally and externally.
Skills and Requirements:
- Masters or PhD in life sciences required.
- At least 4 years of relevant medical writing experience is required.
- Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
- Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.