The Medical Writer is responsible for authoring, reviewing, and coordinating the development of high-quality clinical and regulatory documents that support global clinical development programs.
This role works closely with cross-functional stakeholders to ensure documents are scientifically accurate, strategically aligned, and delivered according to established timelines and medical writing plans.
Key Responsibilities:
Author, edit, and review clinical and regulatory documents, including:
Clinical study protocols and protocol amendments
Investigator Brochures (IBs)
Clinical Study Reports (CSRs)
Briefing Book support
IND and NDA summary documents and other regulatory submission materials
Develop documents that are consistent with regulatory requirements, internal standards, and medical writing plans, while supporting the overall clinical development lifecycle and program objectives for one or more clinical development programs.
Collaborate with cross-functional teams, including Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, to gather, interpret, and integrate scientific and clinical information into clear, accurate, and submission-ready documents.
Negotiate document deliverable milestones and timelines with cross-functional teams to ensure alignment across functions and adherence to medical writing plans and program objectives.
Facilitate document review cycles, resolve reviewer comments, and drive consensus among stakeholders while maintaining quality and schedule commitments.
Ensure documentation complies with applicable regulatory guidance, Good Clinical Practice (GCP), company standards, and industry best practices.
Contribute to the development and continuous improvement of medical writing processes, templates, style guides, and operational procedures.
Support regulatory submissions, health authority interactions, and inspection readiness activities as needed.
Core Competencies:
Scientific and regulatory writing expertise
Project and timeline management
Cross-functional collaboration and influence
Strategic thinking and problem solving
Attention to quality and regulatory compliance
Effective communication and stakeholder management
Skills: Qualifications:
Advanced degree Bachelor's degree or more.
Experience authoring clinical and regulatory documents within the pharmaceutical, biotechnology, or clinical research industry.
Strong knowledge of clinical development, regulatory requirements, and applicable guidance documents (e.g., ICH guidelines).
Excellent scientific writing, editing, and communication skills.
Demonstrated ability to manage multiple projects and negotiate timelines in a cross-functional environment.
Strong organizational skills, attention to detail, and ability to work independently and collaboratively.
Numbers & Facts
Location
Marlborough, MA (Remote)
Salary
$110 Per Hour
Skills
Best Practicesunmatched
Biostatisticsunmatched
Brochuresunmatched
Clinical Informationunmatched
Clinical Practices/Protocolsunmatched
Clinical Study Publicationsunmatched
Clinical Supportunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Data Managementunmatched
Detail Orientedunmatched
Documentationunmatched
Documentation Reviewunmatched
Drug Developmentunmatched
Editingunmatched
GCP (Good Clinical Practices)unmatched
Healthcare Qualityunmatched
Industry Standardsunmatched
Medical Affairsunmatched
Medical Protocolsunmatched
Medical Writingunmatched
Multitaskingunmatched
Negotiation Skillsunmatched
Operations Processesunmatched
Organizational Skillsunmatched
Pharmacovigilanceunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Product Lifecycleunmatched
Project/Program Managementunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Research Protocolsunmatched
Scientific Publicationsunmatched
Style Guideunmatched
Support Documentationunmatched
Time Managementunmatched
Writing Skillsunmatched
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