Associate Director, Clinical and Technical Writing

1 day ago

Lexington, Massachusetts, United States Kiniksa Pharmaceuticals Full time

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. The ideal candidate will bring strategic insight, scientific rigor, and cross-functional collaboration to ensure timely and compliant delivery of key documents that support our innovative pipeline. This position reports to the Senior Director of Regulatory Affairs Strategy.

This position offers remote flexibility, with quarterly travel to our Lexington, MA office preferred.

Responsibilities (including, But Not Limited To)

  • 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.

Qualifications And Experience

  • Bachelor's degree in Life Sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.
  • 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, experience with Veeva preferred.
  • Exceptional writing, editing, and communication skills.
  • Ability to lead/manage multiple projects in a fast-paced environment
  • Kiniksa Benefits Summary - USA

The expected salary range for Associate Director of Clinical and Technical Writing is $178,000 - $189,000 annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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