Reg Affairs & Drug Safety Alliance Mgmt Internship

10 Weeks Internship

Philadelphia, PA - Hybrid (Ability to travel to Philadelphia office 2-4 days per month)

PR: $25-30/hr

Job Description

The Global Regulatory Affairs and Drug Safety (GRADS) Alliance Management Summer Internship opportunity is designed to expose a selected individual to the roles and responsibilities of alliance and vendor management within the pharmaceutical industry setting. The selected individual will gain exposure to alliance and vendor management processes such as business partner agreements and commitment reporting, pharmacovigilance exhibits, and vendor selection, negotiations, and oversight of deliverables for the regulatory affairs and drug safety organization as well as learn of the interactions between disciplines involved in drug development. The focus of this internship is to familiarize the GRADS intern with the various projects, tasks, and work that the GRADS Alliance Management department and GRADS organization contribute to the overall success of the company

Job Responsibilities

• Support and shadow alliance and vendor management activities:

• Learn and develop an understanding of alliance and vendor management, regulatory and safety sciences, drug development framework, and pharmaceutical industry through focused assignments.

• Assist GRADS Alliance Management with managing, updating and reviewing Standard Operating Procedures, Work Instructions, Tools, and Templates.

• Assist with collection and documentation of vendor Key Performance Indicators, Service Level Agreements, and recording of meeting minutes for vendor meetings.

• Gain an understanding of the Organized Data Collection Program process, including concept initiation, vendor/CRO selection, safety requirements and documents, and monitoring.

• Gain an understanding of the Safety Data Exchange Agreements (SDEA) process, including selection, contracts, confidentiality requirements, and adherence to PV regulations regarding data exchange.

• Assist with special projects such as a) organizing information in Teams so there are consistent naming and storage conventions to facilitate quicker search and retrieval of information for audits and inspection, b) preparing dashboards to report on status of objectives, c) reporting on benchmarking information associated with alliance and vendor management functions.

• Prepare presentation(s) for GRADS on an industry or regulatory topic of the intern’s choosing at the end of the program.

• Set up meetings with members of the broader GRA (Global Regulatory Affairs) team to discuss issues specific to assigned projects/tasks to enhance the practical application of the information.

• Set up meetings with other colleagues, relevant to the area of study, in various departments to understand their roles.

• Ensure compliance with company policies, procedures, and training expectations

Education & Qualifications

Required:

• Is currently enrolled in 2nd, 3rd or 4th year of undergraduate college program in the science/life sciences, engineering, healthcare, or business disciplines.
• Ability to travel to Philadelphia office 2-4 days per month
• Strong attention to detail and ability to manage tasks within defined deadlines