Vertex Pharmaceuticals

Vertex Pharmaceuticals Boston, MA, USA
Oct 16, 2020
Full time
We're looking for a candidate to fill this position in an exciting company. • Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance • Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution • Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate • Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and...