Clinical Affairs Specialist III (Fremont, CA)

Thermo Fisher Scientific • Fremont, CA

21h • $100,000 - $133,300 • Hybrid

About The Position

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: Fremont, CA. Relocation assistance is NOT provided.

Requirements

• A bachelor’s or master’s degree with a preference for majors in Biological Sciences is required.
• Must be able to write clear, understandable technical documentation
• Excellent writing and organizational skills with the ability to synthesize technical data into compliant reports.
• High attention to detail, skilled at managing multiple deliverables and collaborating across global time zones.
• Ability to work independently under minimal supervision while maintaining high quality output.

Nice To Haves

• Experience with an excellent understanding of EU IVD regulation and GCP a plus
• Preference for candidate who can work on site at Fremont, California facility. Hybrid option available for strong candidate.

Responsibilities

• Draft and maintain Scientific Validity Reports, Performance Evaluation Plans and Reports, Summary of Safety and Performance, and Post-Market Performance Follow-Up plans and Reports in accordance with EU IVDR regulation for Toxicology and Therapeutic Drug Monitoring Assays, and Clinical Chemistry Controls.
• Update the SOPs and templates as necessary related to IVDR documentation, clinical evidence generation, and post-market follow-up.
• Prepare, review, and archive clinical documentation including study plans, protocols, forms, memos, monitoring reports, data summary, and close-out summaries for all sites involved in the ongoing clinical trial.
• Support clinical site coordination, including communication with investigators, site leads to ensure adherence to approved protocols and regulatory expectations.
• Compile, review, and summarize the clinical data to support regulatory submissions and PMPF activities.
• Manage documentation trackers and ensure traceability of all reports and supporting evidence in the electronic document management system.
• Collaborate cross-functionally with Quality, Regulatory and Research and Development to ensure consistency across technical documentation and clinical submissions.
• Contribute to state-of-the-art literature searches and summaries demonstrating scientific validity and intended purpose of the IVDs.
• Participate in internal and external audits, providing supporting evidence for documentation.
• Perform other duties as assigned to support regulatory readiness, IVDR compliance, and clinical deliverables.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level