Reporting to the Sr. Director, Medical Writing, the Principal Medical Writer is responsible for researching, planning, writing, and editing medical writing deliverables that support clinical development and regulatory writing objectives; works with minimal guidance to achieve goals; and is recognized as a scientific contributor and subject matter expert in preparation of selected clinical/regulatory documents. The Principal Medical Writer is coordinator and lead writer for documents such as clinical study protocols, clinical study reports, investigator’s brochures, summary sections of regulatory submissions.

Responsibilities (including, but not limited to) :

• Manages medical writing projects to prepare clinical/regulatory documentation (e.g., clinical study protocols, clinical study reports, investigator brochures, regulatory submission modules) in support of clinical development, clinical studies, and regulatory submissions, presenting clinical data objectively and clearly in a concise format consistent with industry guidelines
• Manages the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Leads the technical editing activities for assigned projects and reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
• Actively supports cross-functional project teams, representing Medical Writing and taking responsibility for timely and accurate Medical Writing deliverables, negotiating timelines as necessary
• Solves problems associated with Medical Writing scope of work, seeks advice from in-line management and others as needed, and exercises negotiation and communication skills with project team members
• May participate in orientation and coaching of junior team members or working in collaboration with Medical Writing contractors
• Participates in and leads within- and across‑department efforts to continuously improve Medical Writing processes and standards
• Produces high-quality documents with minimal supervision to meet aggressive timelines, ensuring consistent messaging across appropriate documents (nonclinical, clinical, and product labeling)
• Stays up to date on and understands regulatory guidance regarding content for various clinical/regulatory documents and can apply this knowledge

QUALIFICATIONS:

• 6+ years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections)
• Bachelor’s, Masters, or PhD degree in science, medical, clinical, or English/Communications required.
• Ability to lead/manage multiple projects in a fast-paced environment handling multiple demands and experience with project management software (e.g., MS Project, Smartsheet)
• Strong working knowledge of Adobe PDF, MS WORD, EXCEL, and PowerPoint
• Experience with automated document templates and style guides
• Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures
• Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the team
• Ability to interact effectively on cross-functional teams and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
• Excellent presentation, writing, and project management skills
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA
  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

• Manages medical writing projects to prepare clinical/regulatory documentation (e.g., clinical study protocols, clinical study reports, investigator brochures, regulatory submission modules) in support of clinical development, clinical studies, and regulatory submissions, presenting clinical data objectively and clearly in a concise format consistent with industry guidelines
• Manages the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Leads the technical editing activities for assigned projects and reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
• Actively supports cross-functional project teams, representing Medical Writing and taking responsibility for timely and accurate Medical Writing deliverables, negotiating timelines as necessary
• Solves problems associated with Medical Writing scope of work, seeks advice from in-line management and others as needed, and exercises negotiation and communication skills with project team members
• May participate in orientation and coaching of junior team members or working in collaboration with Medical Writing contractors
• Participates in and leads within- and across‑department efforts to continuously improve Medical Writing processes and standards
• Produces high-quality documents with minimal supervision to meet aggressive timelines, ensuring consistent messaging across appropriate documents (nonclinical, clinical, and product labeling)
• Stays up to date on and understands regulatory guidance regarding content for various clinical/regulatory documents and can apply this knowledg