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 role offers remote flexibility, with quarterly travel to our Lexington, MA office preferred.
Responsibilities (including but not limited to):- Deliver High-Impact Scientific Documentation: Author, review, and manage a broad range of clinical, regulatory, technical, and medical documents, including clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs), regulatory submissions (INDs, NDAs, BLAs, briefing documents, CTD modules), CMC documentation, safety narratives, lay summaries, and Medical Affairs materials such as publications, slide decks, and educational content.
- Ensure Strategic Alignment and Consistency: Maintain consistent scientific messaging across documents and ensure alignment with program strategy, regulatory objectives, and organizational priorities.
- Lead the Writing Process End-to-End: Drive document planning, lead cross-functional review and comment adjudication meetings, manage timelines, and ensure on-time, high-quality deliverables across multiple programs.
- Champion Quality and Compliance: Ensure all documents meet internal quality standards and comply with global regulatory requirements, including ICH, GCP, FDA, EMA, and other applicable health authority guidelines.
- Enable Operational Excellence: Maintain version control, audit trails, and document workflows using document management systems such as Veeva Vault and SharePoint. Contribute to the development and maintenance of templates, style guides, and SOPs.
- Develop and Mentor Talent: Provide guidance and mentorship to junior writers and external contractors, fostering best practices and continuous improvement in writing quality and efficiency.
- Support Inspection Readiness: Contribute to regulatory inspections and health authority interactions by ensuring documentation is accurate, traceable, and inspection-ready.
- Partner Across Functions: Serve as a trusted collaborator with Clinical, Regulatory, Biostatistics, CMC, Safety, and Medical Affairs teams to ensure seamless document development and execution.
Standout Skills for Impact:- You bring scientific depth and editorial excellence, with the ability to translate complex clinical data into clear, compelling narratives.
- You balance precision and efficiency while managing multiple deliverables in a fast-paced development environment.
- You influence effectively across functions and levels through strong communication and collaboration.
- You demonstrate a strong commitment to quality, compliance, and regulatory rigor.
- You proactively identify opportunities to improve processes, templates, and documentation standards.
Qualifications and Experience:- Bachelor's degree in Life Sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.
- 12+ years of medical writing experience within the pharmaceutical or biotechnology industry.
- Demonstrated expertise authoring and managing clinical and regulatory documents, including protocols, study reports, investigator brochures, and IND/BLA/NDA sections.
- Strong knowledge of FDA and/or EMA regulations, GCP, and ICH guidelines, with experience working under established SOPs.
- Proficiency in Microsoft Office Suite; experience with Veeva Vault preferred.
- Exceptional written, editing, and verbal communication skills.
- Proven ability to manage multiple projects and priorities simultaneously.
- Salary is commensurate with experience.
- Kiniksa Benefits Summary - USA
The expected salary range for Director of Clinical and Technical Writing is $223,000 - $236,000 annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
