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 #J-18808-Ljbffr Redbock - an NES Fircroft company
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