Responsibilities include, but are not limited to the following:
Develop an understanding of the clinical supply chain organization and its processes.
Interacts with global external vendors and cross functional support teams (QA, stability, etc.)
Responsible for completing specific tasks for assigned projects and studies.
May work on projects with peers from other departments or functions.
Manage basic projects
Executes to a pre-established timeline and project plan and is responsible for completion of specific milestones.
Reviews GMP documentation for operational and technical accuracy.
Works with team members and supervisor to identify and resolve problems.
Basic understanding of reviewing business proposals, contracts, and invoicing. Creates basic request for proposals.
Develops internal cross-functional and external relationships. Manages issues and fosters teamwork.
Participates on cross-functional teams as necessary.
Competencies Required:
Basic knowledge of legislative & regulatory requirements with respect to investigational new drugs.
Teamwork and collaboration skills
Basic negotiation skills
Awareness of drug development process.
Basic analytical and influencing skills.
Basic understanding of Forecasting & Planning requirements.
Basic project management skills.
Basic knowledge of industry technologies
Qualifications
Prerequisite:
Bachelor’s degree preferred. 0 - 3 yrs experience in the pharmaceutical industry preferred.
Skills/Knowledge Required:
BA/BS preferred
0 – 3 years in Pharmaceutical industry related experience preferred
Strong background in cGMP, cGLP, and ICH requirements.
Demonstrated skills in project management and handling multiple projects simultaneously
Familiarity with legislative and regulatory requirements with respect to investigation of new drugs.
Demonstrated teamwork and collaboration skills
Basic knowledge of functional areas and drug development process
Basic analytical skills, able to analyze information / situations.
Awareness and basic understanding of Forecasting & Planning requirements.
Simultaneous