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Kiniksa Pharmaceuticals · 13 hours ago

Associate Director, Clinical and Technical Writing

Lexington, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$178K/yr - $189K/yr

10+ years exp

Kiniksa Pharmaceuticals is seeking a highly motivated and experienced Associate Director of Clinical and Technical Writing to join our dynamic team. This role will be instrumental in supporting the development of high-quality documentation across Clinical, Regulatory, Technical, and Medical Affairs functions.

BiopharmaBiotechnologyMedical

Responsibilities

Author, review, and manage a broad range of documents including:

Clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs)

Regulatory submissions (INDs, NDAs, BLAs, briefing documents, CTD modules)

Technical documents (CMC sections, safety narratives, lay summaries)

Medical Affairs materials (scientific publications, slide decks, educational content)

Ensure consistency of messaging across documents and alignment with strategic objectives

Lead or contribute to document planning meetings, comment adjudication sessions, and submission timelines

Ensure documents meet internal standards and comply with ICH, GCP, FDA, EMA, and other global regulatory requirements

Maintain version control and audit trails using document management systems (e.g., Veeva Vault, SharePoint)

Contribute to the development of templates, style guides, and SOPs

Mentor junior writers or contractors as needed

Support inspection readiness and regulatory authority interactions

Partner with Clinical Development, Regulatory Affairs, Biostatistics, CMC, Safety, and Medical Affairs teams

Qualification

Medical writing experienceClinical document managementFDA/EMEA regulations knowledgeMicrosoft Office SuiteVeeva Vault experienceEditing skillsExceptional writing skillsCommunication skillsProject management

Required

Bachelor's degree in Life Sciences or related field required

10+ years of medical writing experience with a strong scientific background in the pharmaceutical industry

Proven track record in authoring and managing clinical and regulatory documents (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections)

Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures

Strong working knowledge of Microsoft Office Suite

Exceptional writing, editing, and communication skills

Ability to lead/manage multiple projects in a fast-paced environment