Offer summary
Qualifications:
PhD with 6 years or Masters with 10 years of regulatory medical writing experience, Extensive medical writing in clinical study documents and regulatory submissions, Experience authoring responses for Health Authority, Strong project management and organizational skills, Proficient in MS Word, Outlook, some Excel and PowerPoint.
Key responsabilities:
- Write clinical submission documents clearly and concisely
- Contribute to project timelines and organization of documents
- Ensure adherence to regulations and representation of key messages
- Review documents for consistency, structure, and grammar
- Drive the document preparation process and lead resolution meetings independently