Senior Medical Writer – Regulatory & Scientific Leadership

Aroga Biosciences; San Diego (CA); Hybrid; USD 128,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits package

Annual incentive bonus

Job summary

Aroga Biosciences, a full-service CRO, seeks a Principal Medical Writer to lead regulatory and scientific writing for complex submissions. You will translate clinical data into regulatory documents, mentor team members, and help enhance processes and SOPs.

The role combines leadership with hands-on writing, requiring strong writing, regulatory knowledge, and collaboration across multidisciplinary teams. Remote or hybrid in San Diego is supported, with competitive compensation.

Qualifications

• Regulatory writing and submission experience required.
• Strong scientific and medical writing background.
• Ability to independently author and critically review complex regulatory documents.
• Experience with regulatory guidance (GCP, ICH, ICMJE, CONSORT).

Responsibilities

• Author, co-author, and review regulatory and scientific documents for submissions.
• Lead assigned projects and advise on content, format, and regulatory expectations.
• Mentor team members and improve medical writing processes and SOPs.

Skills

Regulatory writing

Scientific writing

Editing

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Master's/PhD/PharmD preferred

Tools

Microsoft Word

PowerPoint

Excel

Job description

Aroga Biosciences, a full-service CRO, seeks a Principal Medical Writer to lead regulatory and scientific writing for complex submissions. You will translate clinical data into regulatory documents, mentor team members, and help enhance processes and SOPs.

The role combines leadership with hands-on writing, requiring strong writing, regulatory knowledge, and collaboration across multidisciplinary teams. Remote or hybrid in San Diego is supported, with competitive compensation.