Clinical Affairs Specialist III

Regulatory Affairs Specialist III

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division-Specific Information:

Carlsbad, CA. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screen.

Discover Impactful Work:

This position is part of the Regulatory and Clinical Affairs organization, which ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically and internationally), and is submitted to the FDA in a complete, accurate, and timely manner for approvals in support of the business units.

A Day in the Life:

The primary role of this position is to support clinical studies and study site management. In this role, the primary responsibilities will include:

• Coordinating and conducting activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
• Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.
• Collect all clinical study essential documents.
• Participate in lab assessment visits.
• Ensure that CRO activities and timelines align with project requirements.
• Implement and document communication with CRO and laboratories to ensure project progress.
• Real-time escalation of clinical study issues to Clinical Study Managers.

Keys to Success:

Education and Experience

• Bachelor's degree in Biology, Chemistry, bioengineering, or related science required.
• 2 years working in the In Vitro Diagnostic or Medical Device Industry. In Vitro diagnostic experience is a plus.
• 2 + years of demonstrated experience with managing in-house and/or external clinical studies.
• Working knowledge of Good Clinical Practices (GCP) is required.
• Certification as a Clinical Research Professional (CCRP) is a plus. If certification is not in place, classwork or coursework in Good Clinical Practices is required.
• Experience working with multi-functional project teams is required.
• Computer literacy, including spreadsheet, database (EDC), and word-processing applications, is required.

Knowledge, Skills, Abilities

• Candidate must be an independent professional who proactively communicates frequently and effectively.
• Must be comfortable working on projects where the project and its team members may be located at other sites.
• Should be at ease with direct communication with internal project team members and external CROs.
• Should be well organized and able to work on multiple projects with tight deadlines.
• Willing to travel away from home on an occasional basis (up to 30% travel).
• High energy level; positive attitude; works well under stress; assertive and effective communicator.
• Hands-on, action-oriented, and able to execute tasks effectively.

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary pay range estimated for this position Regulatory Affairs Specialist III based in California is $83,300.00$105,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount