Senior Medical Writer (FSP)

Location: Frankfurt, Hesse, Germany

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Develop clinical and regulatory documents, including Clinical Trial Reports, trial protocols, Investigator’s Brochures, biomarker reports, and submission documents.
• Manage clinical documents in the Electronic Document Management System, including document setup, approvals, e-approval, publishing, and archiving checks.
• Plan and manage document timelines, review cycles, feedback alignment, and consensus-building with trial and project teams.
• Prepare, conduct, and document kick-off meetings, Results Alignment Meetings, trial team meetings, and submission meetings.
• Write drafts with appropriate tables and figures, integrate review comments, and deliver final document versions.
• Initiate and monitor quality control checks, resolve findings, and complete review and quality control documentation.

Requirements

• Bachelor’s degree in a scientific, clinical, regulatory, or related field; an advanced degree such as MSc, PhD, PharmD, or MD is preferred.
• Approximately 5 years of medical writing experience in the biopharmaceutical, biotechnology, or CRO industry, or equivalent clinical or preclinical development experience.
• Strong knowledge of global regulatory requirements and guidelines, including ICH, FDA, and EMA, across clinical development phases.
• Understanding of clinical research processes, study design, data analysis, and regulatory submission requirements.
• Ability to lead writing activities for complex documents, provide strategic input, manage multiple priorities, and meet tight deadlines.
• Proficiency in Microsoft Word, document formatting, electronic document management systems, document templates, style guides, and structured authoring tools.

Culture & Benefits

• Dedicated work embedded in sponsor processes, workflows, systems, tools, and methodologies.
• Participation in cross-functional project discussions, feedback and alignment meetings, and required training sessions.
• Work in a collaborative, team-oriented environment while operating independently when needed.
• Focus on quality, consistency, scientific accuracy, and seamless collaboration with internal teams.