Intern (Clinical)
- Employer
- Scilex Holding Company
- Location
- Palo Alto, CA
- Start date
- Mar 24, 2023
View more
- Discipline
- Clinical, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Role and Responsibilities
Support Clinical Operations and Medical Affairs as needed.
Review regulatory packets collected by CRO.
Create ICF template and route among different reviewers.
Help with UAT of eDiary
Help with IXR UAT
Review plans, eg: ECG specification and central lab spec docs against the protocol schedule of events
QC CRFs design against the protocol procedures
Assist with pending CDAs and contracts.
Assist with feasibility assessment and site selection.
QC/check the TMF for specific documents related to closeout visits.
Medical Affairs retrospective study data collection at Anu Navani site
Preferred Skills
College student with relevant major, computer skills (MS Office, Excel)
Company
SCILEX HOLDING COMPANY (Nasdaq: SCLX, “Scilex”), majority-owned by Sorrento, is dedicated to the development and commercialization of non-opioid pain management products. We are uncompromising in our focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life.
The company’s lead product ZTlido® (lidocaine topical system) 1.8%, is a branded prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain.
Scilex’s SP-102 (10 mg dexamethasone sodium phosphate viscous gel injection), or SEMDEXA™, for the treatment of Lumbar Radicular Pain has completed enrollment in a Phase III clinical trial and has received Fast Track Status from the FDA. If approved by the FDA, the company expects SP-102 to be the first FDA-approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica, with the potential to replace 10 to 11 million off-label epidural steroid injections administered each year in the US.
SCILEX is committed to harnessing the power of revolutionary delivery technologies designed to safely and effectively provide therapies to those who need them the most.
Scilex Pharmaceuticals and Semnur Pharmaceuticals are wholly-owned subsidiaries of Scilex Holding Company.
- Website
- https://www.scilexholding.com/
- Phone
- (650) 516-4310
- Location
-
960 San Antonio Road
Palo Alto
California
94303
US
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