Job Description
Title: Medical Writer, Clinical Development - Level IV+ (or very high level III)
Duration: 7 months with possible extension
Work Location: remote - Marlborough, MA
Estimated hours per week: 30-40
Position Summary
Key Responsibilities
Core Competencies
Qualifications
Education:
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Duration: 7 months with possible extension
Work Location: remote - Marlborough, MA
Estimated hours per week: 30-40
Position 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
- 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
- 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.
Education:
- Advanced degree Bachelor's degree or more
#ZR
#RESCIE1
#Linkd
Numbers & Facts
| Location | Marlborough, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $100.36–$112.28 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
About Company
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!
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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