Medical Monitor

Responsibilities

• Provide clinical development support across late-stage programs and contribute scientific and medical input to program discussions.
• Review, interpret, and help resolve clinical trial data issues, including tables, listings, figures, and safety and efficacy findings.
• Contribute to the authoring, review, and finalization of clinical and regulatory documents, including CSRs, ISS, ISE, IB updates, DSURs, narratives, and submission-related materials.
• Support study design and conduct by reviewing protocols, amendments, informed consent documents, statistical analysis plans, and other supporting trial documents.

Requirements

• A physician with at least 5+ years of drug development experience.
• Experience with nephrology and/or immunology is preferred.
• Ability to collaborate with internal clinical development, biometrics, regulatory, pharmacovigilance, and CRO partners.
• Experience supporting clinical trial data review, medical data review, issue resolution, and clinical/regulatory document development.

About the role

We are partnering with this company to find a skilled clinical development professional who can provide scientific insight and medical oversight across late-stage programs. Our team is seeking someone who can support data review, regulatory documentation, study conduct, and cross-functional collaboration to help advance important clinical trial activities.

Qualifications

• A physician with at least 5+ years of drug development experience.
• Experience with nephrology and/or immunology is preferred.
• Ability to collaborate with internal clinical development, biometrics, regulatory, pharmacovigilance, and CRO partners.
• Experience supporting clinical trial data review, medical data review, issue resolution, and clinical/regulatory document development.

Skills

• Strong scientific and medical background.
• Excellent communication and collaboration skills.
• Proficiency in regulatory and clinical document development.

Benefits

At SSi People, we believe in putting people first. We offer a comprehensive benefits package that includes:

• Competitive compensation and benefits package.
• Flexible work arrangements to support your personal and professional life.
• Continuous learning and development opportunities.
• A supportive and inclusive workplace culture.

Pay

The salary range for this position is $80,000 - $120,000 annually, commensurate with experience.

Schedule

The role is remote and flexible, allowing for a schedule that best suits your needs.