Medical writer – clinical development

Duties Medical Writer – Clinical Development:

Looking for individual contributor (Hands on keyboard writer for Protocols, CSRs, IB, submission documents, briefing books) Must be available for US work hours (East Coast / West Coast location is not problematic) Employee must be available for US East Coast as well as Japan hours. Occasionally 8 AM US East Coast meetings do occur (Many occur between 9 AM US East Coast time and 5 PM US East Coast time) as well as some 6-8 pm US East Coast time meetings to align with Japan.

5+ years regulatory writing experience Need to have recent experience with CNS (central nervous system) and would be nice to have biologics experience or vaccine experience. Note if only experience is oncology (not a good fit) or only recent experience for many years is oncology they would not be a good fit for our Biologics Business Unit.

Approx 20-40 hours per week (flexing up/down with need) SMPA's hope would be to increase hours and responsibility if the person is available and they are competent and meeting our needs.

Work Location:

remote - Marlborough, MA

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.

Skills; Qualifications

• 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.

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

Education

Advanced degree Bachelor's degree or more.