Reporting Specialist

$27 - $30 per hour with option for medical benefits

6 month initial contract

Hybrid schedule after training - standard first shift business hours

Location: North Chicago, IL

Orion Group and our client a market leading pharmaceutical company, have an exciting contract opportunity for a Reporting Specialist in North Chicago!!!

We are seeking candidates with Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) . Don't pass on this amazing opportunity to join a global leader in Life Sciences!

Job Description:

The Reporting Specialist I is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. They will interface with regulators and serve as the liaison to the respective team when questions and requests arise.

Daily Responsibilities for the Reporting Specialist will include:

• Reporting Specialist I is responsible for executing all of the reporting in accordance with company and FDA regulatory guidelines regarding complaints.
• Decision maker for all reportability decisions
• Lead for all vigilance reporting, including local and global submissions
• Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate
• Ensures that relevant stakeholders have visibility to the reporting and where they are in the process
• Manages regular reporting needs and external requests (i.e. from the FDA)
• Manage the timeline for end to end reporting
• Owns translation services for reporting

Qualifications for the Reporting Specialist:

• High School Diploma or equivalent required. B.S. preferred
• Knowledge and application of computer systems for word processing and complaint management.
• 1+ years of experience working in pharmaceutical/biotech company.
• Knowledge and application of computer systems for word processing and complaint management.
• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
• Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• Solid written/verbal communication and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.