Description
Summary: The Ology Bio Clin/Reg PharmD fellowship program offers a 2-year program to foster the Doctor of Pharmacy position in medical countermeasure development. The PharmD fellow will obtain valuable experience in regulatory affairs and clinical development with exposure to a number of biopharmaceutical platforms and regulatory pathways to product approval, including the FDA Animal Rule.
Essential Position Responsibilities:
- Support clinical operations, clinical technical writing, data management and pharmacovigilance activities
- Evaluate PK/PD in nonclinical and clinical studies
- Prepare clinical documents in support of regulatory filings for biologic, medical device, pharmaceutical and combination products (e.g. 510(k), IND, NDA, and BLA)
- Review clinical development plans in Regulatory Strategies for ongoing programs
- Conduct extensive literature searches to better position regulatory negotiations on topics related to product development
- Establish/maintain a sustained PharmD fellowship program for the Ology Bio Clin/Reg Department
*All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
Position Requirements
- 0-1 year working experience after graduation, excluding internships
- PharmD graduates from accredited College of Pharmacy programs
- High academic standing with a minimum GPA of 3.0
- Research experience (optional)
- Excellent presentation skills
- Analytical skills with strong organization abilities
- Written/verbal communication skills
- Must be eligible to work in the U.S. on a permanent basis, and have permanent residence status
Apply
Visit, https://www.ologybio.com/cdmo-careers/