Medical Writer

Medical Writer

W2 Contract

Pay Rate: $75 - $82 per hour

Location: South San Francisco, CA - Remote Role

Job Summary:

We are seeking a seasoned Medical Writing Contractor to lead the development of mission-critical clinical and regulatory documents. In this role, you will act as a key architect of our clinical narrative, ensuring that our innovative antiviral research is translated into clear, compliant, and high-impact submissions. This is a fully remote, high-autonomy position for a writer who thrives in a fast-paced, science-driven environment.

Duties and Responsibilities:

• Lead the end-to-end process for a broad range of regulatory documents, including Clinical Protocols, CSRs, Investigator Brochures, and DSURs.
• Contribute to high-stakes filings, including INDs/Amendments, BLA/MAA modules, and Briefing Packages.
• Expertly analyze and present complex clinical data, ensuring technical accuracy and alignment with AMA style and company standards.
• Partner with clinical, regulatory, and biostatistics teams to manage document timelines and resolve conflicting priorities.
• Ensure all deliverables meet ICH guidance, GCP standards, and global regulatory requirements.

Requirements and Qualifications:

• B.Sc., M.S., or Ph.D. in a scientific or healthcare-related field.
• Extensive (6 plus) medical writing experience within the biopharmaceutical industry, specifically in clinical regulatory authoring.
• Advanced proficiency in Microsoft Word (styles, templates, and document mapping), Teams, and SharePoint.
• Deep knowledge of medical terminology and a proven ability to interpret and present clinical data analysis.
• Exceptional interpersonal skills with the ability to influence stakeholders and manage resources effectively.
• A "plug-and-play" mindset; able to pivot between projects in a fast-paced environment with challenging deadlines.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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