Director Medical Writer (m/w/d)

Das ist der Job

ppAre you a highly senior, hands‑on Medical Writing expert who thrives in agile, high‑impact environments?

Darum lohnt es sich

Do you want to own global clinical documentation strategies from inception to final submission, while guiding a lean, dedicated team? /p pOn behalf of our partner—a globally acting biopharmaceutical sponsor with a dynamic RD pipeline in the Basel area—we are seeking an bAssociate Director/ Director Medical Writer /b. /p pThis is a unique role that perfectly blends bhigh‑level strategic team and program leadership /b with bhands‑on authoring /b of complex submissions. /p h3Your Mission Key Responsibilities: /h3 pAs the strategic anchor for global marketing applications, you will drive the clinical documentation strategy across multiple development programs with a global reach. /p ul libDisciplinary Leadership Vendor Management: /b Supervise and mentor a lean, highly skilled team of Medical Writers and Disclosure Managers.

Oversee external writing vendors to ensure top‑tier quality and budget adherence. /li libProgram‑Level Submission Leadership: /b 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. /li libHands‑on Authoring Reviewing: /b Independently write and critically review complex regulatory documents, including bCSRs, CTD Module 2 documents /b, briefing packages, investigator brochures, and responses to regulatory agency questions. /li libStrategic Input: /b Act as the subject‑matter expert on global regulatory requirements, providing vital guidance on data‑pooling, analysis plans, and clinical data positioning. /li libInnovation Champion: /b Drive cross‑functional initiatives to enhance templates, authoring tools, and quality systems. /li /ul h3What You Bring (Requirements): /h3 pWe are looking for a stable, senior professional who has driven bPhase 3 clinical programs from beginning to end /b from a medical writing perspective. /p ul libEducation: /b Degree in Life Sciences (BSc minimum; MSc, PhD, PharmD, or MD is highly preferred). /li libDeep Industry Experience: /b b10+ years /b of medical writing experience within pharma/biotech, backed by a proven track record of multiple successful bglobal Phase III submissions /b. /li libProven Leadership: /b Demonstrated experience in bdisciplinary line management /b (direct reports), mentoring junior writers, and managing outsourced vendors. /li libCore Skills: /b Advanced knowledge of global regulatory guidelines, unparalleled ability to interpret complex scientific data, and fluent/advanced written and spoken English. /li libLocation: /b Modern office in the Basel region (3+ days a week on‑site required; non‑negotiable for team collaboration and long‑term sustainability). /li libThe Environment: /b 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. /li libCompensation: /b A highly competitive base salary and premium benefits package tailored to director‑level seniority. /li /ul /p