Director, Medical Writing — Clinical Narratives & Strategy

Regulatory Jobs; Lexington (MA); On-site; USD 225,000 - 239,000; Full time

Job summary

Kiniksa Pharmaceuticals seeks a Director of Medical Writing to lead and mature the medical writing function across clinical development programs. Based in Lexington, MA, this role requires onsite presence five days a week and strategic contribution to high-quality, scientifically robust documents.

You will author and oversee CSRs, protocols, IBs, and program-level deliverables, translating complex data into compelling narratives while aligning messaging across teams.

Qualifications

• Degree in life sciences or related field.
• 8–12+ years of experience in medical/clinical writing in biopharma or CRO.
• Demonstrated expertise in authoring complex clinical documents independently.
• Thorough knowledge of drug development, ICH guidelines, Good Clinical Practice, CTD/eCTD organization, health authority expectations, and relevant pharmaceutical regulations.
• Strong ability to synthesize and communicate complex data clearly.
• Experience working in cross-functional clinical development teams.
• Excellent communication, organization, and stakeholder management skills.

Responsibilities

• Lead the planning, authoring, and review of key clinical documents (CSRs, protocols, IBs).
• Translate complex data into clear, concise scientific narratives.
• Partner with Clinical Development, Clinical Operations, Biostatistics, and Safety to align documents.
• Drive process improvements and template/tool development for medical writing.

Skills

Scientific writing

Storytelling

Attention to detail

Stakeholder management

Autonomy

Education

Life sciences degree

Job description

Kiniksa Pharmaceuticals seeks a Director of Medical Writing to lead and mature the medical writing function across clinical development programs. Based in Lexington, MA, this role requires onsite presence five days a week and strategic contribution to high-quality, scientifically robust documents.

You will author and oversee CSRs, protocols, IBs, and program-level deliverables, translating complex data into compelling narratives while aligning messaging across teams.