Associate Director/ Senior Medical Writer (m/w/d)

Are you a highly senior, hands-on Medical Writing expert who thrives in agile, high-impact environments? Do you want to own global clinical documentation strategies from inception to final submission, while guiding a lean, dedicated team? On behalf of our partner—a globally acting biopharmaceutical sponsor with a dynamic RD pipeline in the Basel area,we are seeking an Associate Director/ Senior Medical Writer. This is a unique role that perfectly blends high-level strategic team and program leadership with hands‑on authoring of complex submissions. Your Mission Key Responsibilities: As the strategic anchor for global marketing applications, you will drive the clinical documentation strategy across multiple development programs with a global reach. Disciplinary Leadership Vendor Management: Oversee external writing vendors to ensure top-tier quality and budget adherence. Program-Level Submission Leadership: Lead, oversee, and coordinate deliverables for full CTD submissions (with a heavy focus on clinical overview and summary modules), ensuring absolute scientific integrity and on‑time global delivery. Hands‑on Authoring Reviewing: Independently write and critically review complex regulatory documents, including CSRs, CTD Module 2 documents, briefing packages, investigator brochures, and responses to regulatory agency questions. Strategic Input: Act as the subject‑matter expert on global regulatory requirements, providing vital guidance on data‑pooling, analysis plans, and clinical data positioning. Innovation Champion: Drive cross‑functional initiatives to enhance templates, authoring tools, and quality systems What You Bring (Requirements): We are looking for a stable, senior professional who has driven Phase 3 clinical programs from beginning to end from a medical writing perspective. Education: Degree in Life Sciences (BSc minimum; MSc, PhD, PharmD, or MD is highly preferred). Deep Industry Experience: 10+ years of medical writing experience within pharma/biotech, backed by a proven track record of multiple successful global Phase III submissions. Proven Leadership: Demonstrated experience managing outsourced vendors. Core Skills: Advanced knowledge of global regulatory guidelines, unparalleled ability to interpret complex scientific data, and fluent/advanced written and spoken English. Location: Modern office in the Basel region (3+ days a week on‑site required; non‑negotiable for team collaboration and long‑term sustainability). The Environment: Mid sized, lean, fast growing and agile biotech which is able to leverage on its global, big sized and well established parent company’s structures, funds and resources. You will not be an anonymous cog in a giant corporate machine; your work has direct, visible impact. Compensation: A highly competitive base salary and premium benefits package tailored to director‑level seniority. #J-18808-Ljbffr