Redbock - an NES Fircroft company
Medical Writer Job at Redbock - an NES Fircroft company in San Diego
Redbock - an NES Fircroft company, San Diego, CA, US, 92189
Contract Length: Three months renewable
Location: San Diego, CA; Local candidates are ideal, must be able to work onsite in office, two-weeks per month
Commitment: 40-hours/week or more
Start: Immediate (backfill due to unexpected departure)
Overview
Our client is seeking an experienced Medical Writer to support critical deliverables across clinical development and regulatory submission activities. This person will work closely with Biostatistics, Programming, Clinical, and cross-functional teams to produce high-quality statistical and clinical documentation on tight timelines.
This is an urgent, onsite-heavy role for someone who thrives in a fast-moving, collaborative environment. This is a great team with an excellent company culture
Key Responsibilities
Lead or contribute to the development of:
Clinical Study Reports (CSRs)
Topline/Interim Results Summaries
ISS/ISE documentation and submission-linked statistical sections
Study reports and statistical result narrativesPublications, abstracts, and manuscripts
Translate statistical analyses and TFLs into clear, accurate written content.
Collaborate closely with Biostatistics and Programming teams to ensure accuracy and consistency.
Manage timelines and document workflows in a fast-paced environment.
Support cross-functional document reviews and respond to comments efficiently.
Ensure alignment with ICH, regulatory, and internal quality standards.
Qualifications
10+ years of experience and BS degree minimum
Strong experience in statistical or regulatory medical writing within pharma/biotech.
Direct experience writing CSRs, topline summaries, and ISS/ISE sections.
Ability to interpret statistical analyses and translate them for regulatory documentation.
Excellent communication skills; clarity, accuracy, and attention to detail.
Ability to thrive in a small-company, high-collaboration environment.
Availability to work onsite in San Diego two weeks/month
Job Details
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Writing/Editing, Strategy/Planning, and Quality Assurance
Industries: Biotechnology Research and Pharmaceutical Manufacturing
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