PV Licensing Technical Specialist (Associate)

Role Summary

PV Licensing Technical Specialist (Associate) role focusing on supporting PV Licensing systems, data quality, and SDEA tracking processes, with responsibilities spanning system management, reporting, and collaboration across functional lines.

Responsibilities

• Support PV Licensing team in developing efficient processes surrounding SDEA activities; uses established procedures to perform assigned tasks.
• Maintain PV Licensing systems and participate in enhancement projects.
• Act as a designated Subject Matter Expert for technical systems related to PV Licensing; apply technical skills to achieve tasks and assist with development of new procedures relevant to the systems used.
• Responsible for creation and generation of reports and metrics from PV Licensing systems.
• Contribute to project tasks; may lead projects with supervision and organize own work to meet deadlines.
• Provide data management support for PV Licensing activities and systems, including managing Quality Events, Data Quality, Quality Checks, Quality Review, and Contact List maintenance.
• Support maintenance of PV Licensing documents in designated central repositories (e.g., GDMS and PV Licensing Shared Drive).
• Develop relationships with functional lines related to SDEA activities; communicate clearly and verify understanding.
• Represent PV Licensing on operational forums as needed; participate in planning and logistics meetings with department management.
• Oversee and import information into repositories for document storage and sharing (e.g., SharePoint, GDMS, PV Licensing repository).
• Participate and contribute as a team member; may develop PV Licensing team presentations.
• Identify and resolve potential problems with basic complexity; complete assignments independently using appropriate methods.
• Handle confidential information appropriately.
• Manage project activities as assigned by PV Licensing Team Lead; exercise judgement to complete tasks.
• Provide support for PV Licensing Leads on operational and administrative issues; participate in special projects as required.
• Develop, implement, and use standardized working practices within the PV Licensing team based on global standards to ensure optimal usage and tracking of information.

Qualifications

• Bachelor‚Äôs degree (preferably in a scientific or technical field) and relevant 3+ years industry experience.
• Experience within or close interaction with Safety and/or Regulatory functions within a pharmaceutical company or Clinical development functions to understand operational requirements.
• Experience with resource management, administrative capabilities, MS Office software, audio/video equipment, and telecommunication technology.
• Strong verbal and written communication skills and strong organizational and project management skills.
• Detail-oriented with demonstrated success in process development and improvement.
• Ability to develop cross-functional relationships at all levels and adapt to changing priorities while managing several projects.

Technical Skills

• Fundamental and specialized knowledge in procedures, techniques, tools, materials, and equipment needed for the position.
• Contributes to completion of projects and tasks; identifies and implements delivery and process improvements.
• Fully trained in MS Office Applications.
• Knowledge of data management systems and related applications (e.g., Internet Explorer, Visio, WebEx, AV equipment, telecommunication tech).

Education

• Bachelor‚Äôs degree in a scientific or technical field is preferred.