Director, Clinical and Technical Writing

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    "requisitionDescription": "<div><div><div><div><div><div><div><div><div><div><div><div><div><div><div class=\"fr-view\"><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;' data-pasted=\"true\"><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">Kiniksa Pharmaceuticals is seeking a highly motivated and experienced 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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">This role offers remote flexibility, with quarterly travel to our Lexington, MA office preferred.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><strong>Responsibilities (including but not limited to):</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Deliver High-Impact Scientific Documentation:&nbsp;</strong>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.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Ensure Strategic Alignment and Consistency:</strong> Maintain consistent scientific messaging across documents and ensure alignment with program strategy, regulatory objectives, and organizational priorities.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Lead the Writing Process End-to-End:</strong> Drive document planning, lead cross-functional review and comment adjudication meetings, manage timelines, and ensure on-time, high-quality deliverables across multiple programs.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Champion Quality and Compliance:</strong> Ensure all documents meet internal quality standards and comply with global regulatory requirements, including ICH, GCP, FDA, EMA, and other applicable health authority guidelines.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Enable Operational Excellence:</strong> 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.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Develop and Mentor Talent:</strong> Provide guidance and mentorship to junior writers and external contractors, fostering best practices and continuous improvement in writing quality and efficiency.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Support Inspection Readiness:</strong> Contribute to regulatory inspections and health authority interactions by ensuring documentation is accurate, traceable, and inspection-ready.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Partner Across Functions:</strong> Serve as a trusted collaborator with Clinical, Regulatory, Biostatistics, CMC, Safety, and Medical Affairs teams to ensure seamless document development and execution.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><strong>Standout Skills for Impact:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">You bring scientific depth and editorial excellence, with the ability to translate complex clinical data into clear, compelling narratives.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">You balance precision and efficiency while managing multiple deliverables in a fast-paced development environment.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">You influence effectively across functions and levels through strong communication and collaboration.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">You demonstrate a strong commitment to quality, compliance, and regulatory rigor.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">You proactively identify opportunities to improve processes, templates, and documentation standards.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><strong>Qualifications and Experience:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Bachelor&rsquo;s degree in Life Sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">12+ years of medical writing experience within the pharmaceutical or biotechnology industry.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Demonstrated expertise authoring and managing clinical and regulatory documents, including protocols, study reports, investigator brochures, and IND/BLA/NDA sections.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong knowledge of FDA and/or EMA regulations, GCP, and ICH guidelines, with experience working under established SOPs.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Proficiency in Microsoft Office Suite; experience with Veeva Vault preferred.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Exceptional written, editing, and verbal communication skills.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Proven ability to manage multiple projects and priorities simultaneously.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Salary is commensurate with experience.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Kiniksa Benefits Summary &ndash; USA</strong></li></ul></div><p><span style=\"color: rgb(0, 0, 0); font-family: arial, sans-serif; font-size: 14px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; float: none; display: inline !important;\" data-pasted=\"true\">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.</span></p><p><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">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.</span></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>\n",
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