Medical Writer – Clinical Development at The Fountain Group | Torre

Medical Writer – Clinical Development

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Full-time

Legal agreement: To be defined

Compensation USD76.1/hour
location_on
Marlborough, MA, USA
Shared by
Julien PETIT
5 days ago

Responsibilities


The Fountain Group is currently seeking a Medical Writer for a prominent client of ours.Medical Writer - Clinical DevelopmentJob DescriptionThe Medical Writer - Clinical Development will author, edit, and review clinical and regulatory documents supporting global clinical development programs. Responsibilities include:Author clinical study protocols and protocol amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing book materials, and IND/NDA summary and submission documents.Develop documents aligned with regulatory requirements, internal standards, medical writing plans, and clinical development objectives.Integrate scientific and clinical information from Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs functions.Manage document review cycles, incorporate reviewer comments, and coordinate deliverables against established medical writing timelines.Support regulatory submissions, health authority interactions, and inspection readiness activities.Contribute to medical writing templates, style guides, processes, and operational procedures.EducationBachelor's degree or higher in a relevant scientific, medical, or related discipline.Advanced degree preferred.Required SkillsHands-on medical writing experience withtechnology, CRO, or clinical research environments.Experience authoring or reviewing Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and Investigator Brochures (IBs).Experience with IND/NDA summary documents and regulatory submission materials.Knowledge of clinical development processes and ICH guidelines.Working knowledge of Good Clinical Practice (GCP) and clinical/regulatory documentation requirements.Experience supporting global clinical development programs and regulatory documentation.Preferred SkillsExperience developing briefing book materials for regulatory interactions.Experience supporting health authority interactions and inspection readiness.Experience developing or maintaining medical writing templates, style guides, and standard operating procedures.Experience managing multiple clinical/regulatory document deliverables across development programs.