Senior Medical Writer, Clinical Evaluation Expert

Abbott; Santa Clara (CA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Medical coverage (HIP PPO)

Retirement plan with employer contrib.

Tuition reimbursement / FreeU

Job summary

Abbott is seeking a Senior Medical Writer, Clinical Evaluation, to join our Regulatory Clinical Evaluation team at our U.S. sites. You will author Clinical Evaluation Reports and related regulatory documents for Neuromodulation, CAHF, and Vascular products.

You will evaluate clinical evidence, collaborate with stakeholders, and ensure compliant deliverables across product lifecycles, with emphasis on quality and regulatory standards. Maple Grove MN/Santa Clara CA sites offer on-site roles.

Qualifications

• Bachelor’s degree in Science or equivalent.
• 3+ years in R&D, technical product development, or quality in healthcare.
• Strong written and verbal communication, multitasking and prioritization.
• Experience writing engineering/technical documentation for new products.

Responsibilities

• Author CERs, CEPs, PMS/PMCF plans and reports.
• Summarize clinical evidence from literature and studies.
• Collaborate with cross-functional teams on CER projects.
• Support regulatory submissions and inquiries and risk management.
• Ensure quality and regulatory compliance of deliverables.

Skills

Clinical writing

Regulatory writing

Quality systems

Project management

Communication

Education

Bachelor’s degree in science

Job description

Abbott is seeking a Senior Medical Writer, Clinical Evaluation, to join our Regulatory Clinical Evaluation team at our U.S. sites. You will author Clinical Evaluation Reports and related regulatory documents for Neuromodulation, CAHF, and Vascular products.

You will evaluate clinical evidence, collaborate with stakeholders, and ensure compliant deliverables across product lifecycles, with emphasis on quality and regulatory standards. Maple Grove MN/Santa Clara CA sites offer on-site roles.