Technical Writer/Labeling Specialist

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

USDM is looking for an enthusiastic Technical Writer/Labeling Specialist to join our team. The Technical Writer/Labeling Specialist will execute to deliver high quality documentation and in-product text updates for Instructions for Use and Packaging Component Labels.

Primary Responsibilities

• Research, write, edit, compile, revise, and review end-user documentation with minimal support from the Lead.
• Working on Service manuals, IFUs, knowledge of medical symbols
• Create Change Markup, PDF View file, Signature File
• Develops, writes, edits, and maintains technical documentation.
• Locate proper source Labeling in Agile
• Strong written and oral communication skills
• Locate source Labeling, Save As with the new items, update address
• Save As to create new Item Masters, Check fields for accuracy
• Great attention to detail
• Strong organizational skills
• Good analytical and problem-solving skills
• Working with engineers and subject matter experts

Additional Responsibilities

• Performs other related duties and assignments as required.

Qualifications

• Knowledge of Agile Software Document Management Solution.
• Functional knowledge of Microsoft Office Suite (MS Word, MS Excel).
• Basic knowledge of QSR/GMP (preferred).
• Knowledge of digital content software applications such as MadCap Flare or Author It.
• Basic experience w/ print publishing, design, or document control programs.
• Demonstrated knowledge in DTP software applications, Adobe FrameMaker.

Education & Certifications

• University certificate or degree with a minimum of 1 year of related industry exp.

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:

• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
• 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.

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.

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: https://usdm.com/careers