Job Summary

Provides critical support to Medical Affairs, specifically with the Investigator Initiated Studies (IIS) Program, tracking of Non-Disclosure Agreements (NDAs) and granted study agreements, as well as managing the tracking and shipping of medical devices.

Key Accountabilities

• Maintain accurate records of all NDAs and research agreements
• Monitor the status of research agreements and ensure timely execution
• Manage the inventory of medical devices used in Investigator Initiated Studies, including coordination of shipments and returns of loaned devices to and from research sites
• Maintain approprate records to support successful reporting for loaned / free-of-charge materials; attend audits of compliance records as neeeded
• May support the clinical affairs team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
• Coordinate and communicate with investigators, and legal and compliance teams to address any issues or delays
• Work with logistics and supply chain teams to resolve any shipping issues
• Performs other duties and responsibilities as assigned.

Networking/Key relationships

• Medical Affairs
• Operations (Logistics)
• Legal and Compliance
• External Stakeholders (Investigators, clinical study participants, etc)

Minimum Knowledge & Experience for the position:

• High School Diploma or equivalent required
• 3 years of administrative support experience

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Strong working knowledge of Microsoft Word, Excel, and PowerPoint
• Demonstrated written and oral communication skills
• Detail-oriented and highly organized
• Ability to work independently
• Great attention to detail and exceptional organization skills.
• Respects the need for compliance to applicable regulatory requirements.

Travel requirements:

Up to 5% of time. Periodic travel may be required to other Werfen sites.