Senior/Principal Manager, Medical & Scientific Writing

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🔥 1 minute ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

✏️ Content Writer

👻 Ghost score 10%

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Immatics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2000

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Immatics is a biotechnology company focused on developing targeted immunotherapies for cancer patients, particularly in treating solid tumors. The company combines the discovery of cancer immunotherapy targets with the development of specific T cell receptors to enable a robust immune response. Immatics' pipeline includes Adoptive Cell Therapies and TCR Bispecifics, and it collaborates with global leaders in the pharmaceutical industry. The company's mission is to advance its therapies to improve the lives of cancer patients, and it maintains a strong commitment to innovation in immunotherapy technologies.

📋 Description

• Independently manage assigned medical writing activities for late-stage clinical trials and associated regulatory submissions • Plan, author, and coordinate clinical documents for BLA submissions • Prepare regulatory documents supporting Phase 3 and early clinical trials, clinical trial applications in Europe, and IND submissions in the USA • Prepare clinical trial protocols and amendments, investigator’s brochures, and clinical sections of Investigational Medicinal Product Dossiers • Prepare briefing books for scientific advice meetings in Europe and the USA • Write medical and scientific sections and develop document strategies • Coordinate cross-functional input, reviews, and comment resolution • Manage document timelines, dependencies, and deliverables to meet study and submission milestones • Provide oversight of external medical writers and vendors • Perform and coordinate quality control of medical and scientific documents • Research scientific and clinical development topics and integrate findings into regulatory documents and internal summaries • Collaborate with clinical and non-clinical teams in an interdisciplinary environment • Contribute to development of PRAME immunotherapies for patients with cancer

🎯 Requirements

• Master’s degree, preferably a PhD, in life sciences, medicine, pharmacy, or a related field • 4+ years of medical writing experience in the biopharmaceutical industry or a comparable environment • Substantial experience with Phase III clinical trials and BLA submissions • Strong understanding of regulatory requirements for clinical documents and submissions • Ability to translate complex efficacy and safety data into clear, scientifically sound regulatory documents • Excellent English writing skills • Strong analytical and organizational abilities • High level of accuracy • Ability to work independently and collaborate effectively across functions • Ability to manage complex reviews and timelines • Experience overseeing external medical writers or vendors preferred • Expertise in immuno-oncology, particularly T-cell therapies or T-cell-engaging bispecifics, highly desirable • Experience using AI-assisted tools for medical writing and document quality control is an advantage

🏖️ Benefits

• Company-sponsored pension scheme • Childcare support • Continuous learning opportunities • Flexible “Two Out of Three” benefits concept • Subsidies for two of: EGYM Wellpass, JobRad, and JobTicket • Family-friendly work environment • Flexible work arrangement, including remote work within Germany

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