Job Information
About the Position
Introduction
Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Overview
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.
Responsibilities
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)
Qualifications
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.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com
