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1–2 jobs· newest first

Medical Writer – Clinical DevelopmentNew
Sunrise Systems Inc · Remote, US
Remote · Contract · Mid
Director, Statistical Programming - Immunology
AbbVie · Irvine, US
Hybrid · Manager

+10K new in the last hour

S

Medical Writer – Clinical Development

Sunrise Systems Inc · Posted Nov 11, 2026

Remote, United States
Remote
Contract · Mid
5+ years

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AI

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The Medical Writer is responsible for authoring, reviewing, and coordinating the development of high-quality clinical and regulatory documents that support global clinical development programs.

Compensation

The hourly rate for this position is between $XX-XX per hour.

Responsibilities

Author, edit, and review clinical and regulatory documents, including Clinical study protocols and protocol amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Briefing Book support, IND and NDA summary documents and other regulatory submission materials
Develop documents that are consistent with regulatory requirements, internal standards, and medical writing plans, while supporting the overall clinical development lifecycle and program objectives for one or more clinical development programs
Collaborate with cross-functional teams, including Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, to gather, interpret, and integrate scientific and clinical information into clear, accurate, and submission-ready documents
Negotiate document deliverable milestones and timelines with cross-functional teams to ensure alignment across functions and adherence to medical writing plans and program objectives
Facilitate document review cycles, resolve reviewer comments, and drive consensus among stakeholders while maintaining quality and schedule commitments

Requirements

Bachelor's degree or more
Nice to have: Biologics experience
Nice to have: Vaccine experience

Skills

Scientific writing Regulatory writing Clinical development knowledge ICH guidelines knowledge

Benefits

ACA compliant medical coverage
Dental insurance
Vision insurance
Sick time benefits

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Director, Statistical Programming - Immunology

AbbVie · Posted Nov 6, 2026

Irvine, California, United States
Hybrid
Manager
12+ years

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Lead and manage the statistical programming team to ensure efficient and high-quality deliverables across multiple therapeutic areas within immunology.

Responsibilities

Oversee a team of statistical programmers
Provide strategic guidance on programming activities
Ensure compliance with regulatory requirements
Develop and maintain standard operating procedures
Collaborate with cross-functional teams

Requirements

MS in Statistics, Computer Science or related field
BS in Statistics, Computer Science or related field
Nice to have: Immunology experience
Nice to have: Experience utilizing AI in statistical programming activities

Skills

SAS programming Macro development Pharmaceutical experience with clinical trials Familiarity with FDA and EMEA NDA/BLA filing experience ISS or ISE experience

Management experience

Leadership of direct reports

ICH Guidelines knowledge

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)

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