A global, Top 10 pharmaceutical organization in Northern New Jersey is seeking a Principal Medical Writer to join their established Medical Writing team and contribute to their ever growing portfolio of blockbuster products. This position offers remote flexibility.
- Act as lead writer for all clinical and regulatory deliverables including but not limited to CSRs, Protocols, IBs, DSURs/PSURs
- Communicate timelines, documents needed and process standards to team
- Review all regulatory/clinical documents composed by external resources
- Serve as the division representative on project team meetings
- Interpret and explain data from a variety of internal and external sources
- Advanced degree within a scientific discipline
- 5+ years of clinical and regulatory writing experience within the pharma/biotech industry
- 2+ years of industry experience preferred
-Strong familiarity with Regulatory Agency guidelines
- Exceptional written and verbal communication skills
Please contact Paige Pecora on +1 718-753-4453 or email firstname.lastname@example.org if you would like to know more about this opportunity. This will be 100% confidential.