Job Summary
A pharmaceuticals company is seeking a Remote Regulatory Writing Associate Director.
Must be able to:
- Lead writing team for complex submissions
- Ensure compliance of documentation to internal company standards and external regulatory guidelines
- Author, review and/or independently handle high quality clinical and safety documents
Must meet the following requirements for consideration:
- Minimum university life science degree or equivalent is required
- ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge
- Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements)
- Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs
- Expert knowledge of biostatistics principles
