Senior/Principal Manager, Medical & Scientific Writing

This is a fully remote position, open to applicants in Germany.

📋 Description

• Take the initiative to oversee medical writing tasks related to late-stage clinical trials and corresponding regulatory submissions.

• Plan, draft, and manage clinical documentation for Biologics License Application (BLA) submissions.

• Prepare regulatory documents that support Phase 3 and early-stage clinical trials, including clinical trial applications in Europe and Investigational New Drug (IND) submissions in the USA.

• Draft clinical trial protocols and amendments, investigator brochures, and clinical sections of Investigational Medicinal Product Dossiers.

• Create briefing books for scientific advisory meetings in both Europe and the USA.

• Compose medical and scientific sections and formulate document strategies.

• Coordinate contributions from various functions, manage reviews, and resolve comments effectively.

• Oversee document timelines, dependencies, and deliverables to ensure alignment with study and submission deadlines.

• Provide guidance for external medical writers and vendors.

• Conduct and manage quality control processes for medical and scientific documents.

• Investigate scientific and clinical development topics and integrate insights into regulatory documents and internal summaries.

• Collaborate with both clinical and non-clinical teams in a multidisciplinary setting.

• Contribute to the advancement of PRAME immunotherapies aimed at cancer patients.

⛳️ Requirements

• A Master’s degree, preferably a PhD, in life sciences, medicine, pharmacy, or a related discipline.

• At least 4 years of medical writing experience in the biopharmaceutical sector or a similar field.

• Significant experience with Phase III clinical trials and BLA submissions.

• Strong knowledge of regulatory standards for clinical documents and submissions.

• Ability to convert intricate efficacy and safety data into coherent, scientifically robust regulatory documents.

• Excellent proficiency in English writing.

• Strong analytical and organizational skills.

• High level of precision in work.

• Capability to work autonomously and collaborate effectively across various functions.

• Experience in managing complex reviews and timelines.

• Experience supervising external medical writers or vendors is preferred.

• Expertise in immuno-oncology, specifically T-cell therapies or T-cell-engaging bispecifics, is highly desirable.

• Familiarity with AI-assisted tools for medical writing and document quality control is a plus.

🏝️ Benefits

• Company-sponsored pension plan.

• Childcare assistance.

• Opportunities for continuous learning.

• Flexible “Two Out of Three” benefits model.

• Subsidies for two of the following: EGYM Wellpass, JobRad, and JobTicket.

• Family-oriented work environment.

• Flexible work arrangements, including the option for remote work within Germany.