Job Description
Job Title: Medical Writer Clinical Development
Location: Remote Marlborough, MA
Duration: 6 Months
Pay Rate: $110 $112.28/hour
Job Summary
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
Core Competencies
Qualifications
Education
Location: Remote Marlborough, MA
Duration: 6 Months
Pay Rate: $110 $112.28/hour
Job Summary
- Estimated hours per week: 30 40
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
Qualifications
- Bachelor's degree or higher; advanced degree preferred.
- 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.
Education
- Bachelor's degree or higher; advanced degree preferred.
Numbers & Facts
| Location | Marlborough, MA (Remote) |
| Industry | Other/Not Classified |
| Company Size | 100 to 499 employees |
| Year Founded | 1998 |
| Website | www.eteaminc.com |
About Company
Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.
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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