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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing for late-stage clinical trials and regulatory submissions, with a strong focus on BLA submissions and Phase III clinical trials. Proficient in collaborating across interdisciplinary teams and managing document quality control.
Highest-signal resume keywords
Medical Writing ExperienceRegulatory Document PreparationPhase III Clinical TrialsBLA SubmissionsImmuno-Oncology Expertise
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Document AuthoringRegulatory Submission PreparationDocument Strategy DevelopmentQuality Control of Medical DocumentsData Translation into Regulatory Documents
Soft Skills
Analytical AbilitiesOrganizational SkillsCollaboration SkillsIndependent Work CapabilityAttention to Detail
Tools & Technologies
AI-Assisted Tools for Medical Writing
Certifications & Qualifications
Master’s Degree in Life SciencesPhD in Related Field Preferred
Industry Keywords
Biopharmaceutical IndustryClinical TrialsInvestigational Medicinal Product DossiersT-Cell TherapiesBiosimilars
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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