Medical Writer

Advanced Recruiting Partners; United States; Presencial; USD 70 000 - 110 000; Tempo integral

Resumo da oferta

Advanced Recruiting Partners is seeking Medical Writer – Regulatory Writing to develop, review, and edit clinical and regulatory documents for pharmaceutical, biotechnology, and medical device programs.

You will collaborate with cross-functional teams to ensure accuracy, scientific soundness, and regulatory compliance across multiple projects and timelines.

Qualificações

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 2+ years of medical or regulatory writing experience in CRO/pharma/biotech.
• Experience writing clinical and regulatory documents; knowledge of ICH and GCP.

Responsabilidades

• Prepare and edit regulatory and clinical documents for health authority submissions.
• Develop CSRs, clinical protocols, investigator brochures, consent forms, safety reports, and submission materials.
• Translate complex data into clear, well-organized documents; ensure regulatory compliance.

Conhecimentos

Scientific writing

Editing

Regulatory writing

Communication

Attention to detail

Formação académica

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Ferramentas

Microsoft Word

Excel

PowerPoint

Descrição da oferta de emprego

Multiple Medical Writing openings !!! Great opportunity with a small CRO!

Medical Writer – Regulatory Writing

The Medical Writer will be responsible for developing, reviewing, and editing clinical and regulatory documents in support of pharmaceutical, biotechnology, and medical device programs. This role will work closely with clinical, regulatory, safety, and other cross-functional teams to ensure documents are accurate, consistent, scientifically sound, and compliant with applicable regulatory requirements.

Responsibilities

• Prepare and edit regulatory and clinical documents for submission to health authorities.
• Develop documents such as clinical study reports (CSRs), clinical protocols, investigator brochures, informed consent documents, safety reports, and regulatory submission materials.
• Review and interpret clinical and scientific data and translate complex information into clear, concise, and well-organized documents.
• Ensure documents follow applicable regulatory guidelines, company procedures, and client requirements.
• Collaborate with clinical, biostatistics, data management, regulatory affairs, pharmacovigilance, and other project team members.
• Manage multiple projects and timelines while ensuring high-quality deliverables.
• Participate in document review cycles and incorporate feedback from internal and external stakeholders.
• Perform quality control and consistency checks on assigned documents.
• Support development and maintenance of templates, style guides, and standard processes.
• Conduct literature and background research as needed to support document development.
• Ensure appropriate referencing, formatting, and documentation of source materials.
• Communicate project status, timelines, and potential issues to project teams and management.
• Support client meetings and discussions related to assigned writing projects.
• Stay current with applicable regulatory guidance and industry standards.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline; advanced degree preferred.
• 2+ years of experience in medical or regulatory writing within a CRO, pharmaceutical, biotechnology, or related environment.
• Experience writing clinical and/or regulatory documents.
• Strong understanding of clinical development and the drug development process.
• Knowledge of applicable regulatory guidelines and standards, including ICH and GCP.
• Excellent scientific writing, editing, and proofreading skills.
• Ability to interpret and communicate complex scientific and clinical information clearly.
• Strong attention to detail and organizational skills.
• Ability to manage multiple projects and meet deadlines.
• Strong communication and collaboration skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, and related documentation tools.
• Experience working in a CRO environment and directly with pharmaceutical or biotechnology clients is preferred.