Contract: 06 months contract on W2 with possible extension
Key Responsibilities
Provide operational support to departmental projects or larger scale department/division-wide efforts. Duties may include tracking information and generating reports, research and follow through, schedule coordination and database management.
Purpose: • The Reporting Specialist I is responsible for executing all 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.
Responsibilities: • 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: • 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.
Years of experience/education and/or certifications required: • 1+ year experience
Top 3-5 skills requirements • 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.
Nice to have (but not required) • Degree is preferred • Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. • Clinical background including bio background, nursing, physicians from other countries without US practice has worked out as well.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.