The Director, Regulatory Writing is responsible for overseeing and participating in writing, reviewing, and editing clinical, and regulatory documents including but not limited to clinical study protocols, protocol amendments, clinical study reports, clinical summaries, and regulatory authority meeting materials. This individual will work hands-on with teams to develop the aforementioned types of documents and will also manage external consultants while serving as the main Regulatory Writing contact for assigned projects/programs.  The Director, Regulatory Writing will work closely with cross-functional teams to ensure the documents are high quality, completed on time, and in compliance with ICH/GCP/regulatory guidelines, SOPs, and company goals. This individual may also support other Regulatory Writing activities as requested.

Responsibilities

• Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, Investigator’s Brochures, IND/NDA/BLA clinical summaries, and other documents as required for submissions.  In addition, provide support for health authority briefing documents, and responses to questions/requests for information, as needed
• For assigned programs and projects, serve as the primary Regulatory Writing point of contact for submission and project teams, overseeing authoring and QC work performed by consultants and contractors
• For large, complex documents (e.g., CSRs) work with the document owner to plan kickoff meetings and define overall timelines from the initial draft through content approval
• Arrange and conduct review meetings with teams and independently resolve document content issues and questions arising from the writing/review process
• Work with cross-functional stakeholder groups, including Clinical Research, Biometrics, and Drug Safety, to set priorities for document preparation and collaborate on document content.
• Provide status/updates of Regulatory Writing deliverables to management
• Represent Regulatory Writing on project teams and advise on content and format requirements for various documents
• Develop timelines and communicate the writing process and timelines to team members
• Serve as the owner for templates for Regulatory documents, Module 2 summaries, clinical study reports, and the Cytokinetics Style Guide
• May contribute content to safety documents (e.g., DSURs, RMPs)
• Assist in the development of SOPs for Regulatory Writing processes
• Serve as a subject matter expert on systems and process initiatives including document management system implementations and updates to document development practices
• Comply with established company policies and procedures, and industry and regulatory guidelines
• Other duties as assigned

Qualifications

• BA/BS in one of the life sciences with a minimum of 12 years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 4+ years of relevant regulatory/medical writing experience
• Excellent communication skills both orally and in writing
• Ability to work both independently and in cross-functional team environments with minimal supervision
• Demonstrated ability to lead the development of large/complex regulatory and clinical documents including but not limited to:  clinical study reports, module 2 summaries, and regulatory authority meeting briefing documents
• Ability to manage consultants/contractors
• Ability to work effectively in a fast-paced environment with multiple high-priority projects
• Project management skills
• Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP)
• Strong written and verbal communication skills. Ability to engage and disseminate information among appropriate stakeholders for effective document production.
• Attention to detail with an ability to detect errors and inconsistencies in various types of documents

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer