- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... AND RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways.… more
- Novo Nordisk (Lexington, MA)
- … submissions, which may include: + Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational ... About the Department Our East Coast Global Development Hub brings together the best minds...teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of… more
- Novo Nordisk (Lexington, MA)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and ... Therapy Designation requests + Clinical summary and overview documents in eCTD format for global regulatory submissions + Shares knowledge and experience to… more