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About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

The Data Specialist will be responsible for collecting, analyzing and maintaining regulatory approval data and documents for products across the organization as directed. The Data Specialist will support data conversions for migration into data control software, contribute to data governance initiatives and participate in the definition and mapping of regulatory business processes to control and maintain approval data and documents.

Primary Responsibilities

• Review various regulatory filings, products, labels, IFUs and information systems to identify and collect the relevant approval data and documents required for the launch of data uploads for the MDR and Global Regulatory Information Management System (RIMS).
• Assist with research activities to obtain missing, partial or conflicting historical data or documents.
• Read and use information from existing regulatory documents and information systems to identify and list the SKU(s) covered by a single regulatory approval.
• Analyze data across multiple information systems, identify discrepancies and coordinate with regulatory leads for the impacted product line or region to resolve any data discrepancies.
• Interface with multiple departments including Information Management Systems, Corporate and Regional Regulatory representatives, Quality, Engineering, Product Development, etc.
• Coordinate with various departments to approve and lock data after it has been verified.
• Track progress of data collection and verification as assigned.
• Enter data into established repository by inputting alphabetic and numeric information utilizing training provided.
• Maintain and update regulatory data and documents throughout their lifecycle and as product changes are implemented.
• Assist with documenting processes and procedures for the collection, verification, control, and maintenance of approval data and documents.
• Follow best practices for data collection, data storage and database management.

Additional Responsibilities

• Participate in project team meetings and be accountable for assigned tasks.
• Contribute to the clients regulatory department effort and other regulatory information needs as required.

Qualifications

• 1-2 years relevant experience in data governance, management or analysis.
• Familiar with enterprise software management tools such as Oracle and Agile PLM preferred.
• Must be detail-oriented, proactive, adaptable and a fast learner.
• Must be able to work both in an office setting and remotely.
• Excellent organizational, teamwork, and collaboration skills.
• Demonstrated ability to acknowledge issues or problems and work quickly to identify solutions.
• Basic to intermediate skill in data analysis using Microsoft Excel or similar software.
• Basic skill with common software applications including Microsoft Word, Outlook, PowerPoint, Visio and Adobe Acrobat.

Education & Certifications

• Bachelor’s Degree preferred.

Compensation

Salary/Hourly Rate Range (W2): USD 30.00 – 40.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: http://www.usdm.com/careers

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
• Travel to client site for onsite work as needed.

Equal Opportunity Statement

USDM Life Sciences 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.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.