Cytokinetics

Sales

• Deliver sales results, work autonomously, and serve as single point of accountability for the successful launch within your territory
• Develop territory-specific account plans that identify, assess, and prioritize opportunities to meet customer needs by coordinating the efforts of a local integrated field team consisting of medical, payer, and patient navigation/support colleagues
• Be a subject matter expert and resource to customers through the delivery of clinically relevant disease and product information while focusing on creating demand for the product launch
• Communicate approved resources to HCPs for the benefit of HCM patients such as marketing materials, payer information, formulary coverage, patient support services, and educational programs

Cardiovascular Account Specialist

Content Writer

• Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, clinical summaries, and other documents as required for complex submissions (IND/NDA/BLA/MAA)
• Provide support for health authority briefing documents, and responses to questions/requests for information, as needed
• Serve as the primary point of contact for submission and project teams while acting as the lead author for complex documents while supporting document timelines and content strategy
• Plan kickoff meetings, define overall timelines and lead authoring and comment resolution, from the initial draft through final approval
• Arrange and conduct comment resolution/review meetings with cross-functional teams and depending on nature and complexity resolve document content issues independently or collaboratively
• Work with cross-functional stakeholder groups, including Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology etc. as a significant contributor to set priorities for document preparation, collaborate on document content, and ensure scientific accuracy and alignment
• Represent Regulatory Writing on project teams and advise on fit for purpose content and format requirements for various documents
• Develop and drive timelines, and communicate writing process and timelines to team members
• Provide status/updates of Regulatory Writing deliverables to management
• Share and implement Regulatory Writing best practices to ensure efficiency and consistency across product teams
• May contribute content to safety documents (e.g., DSURs, RMPs)
• May 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.

Senior Manager, Regulatory Writing

Manager

• Lead day-to-day oversight and strategic management of study-specific TMFs
• Drive adherence to Cytokinetics’ TMF SOPs, policies, and regulatory requirements
• Support inspection preparation activities
• Provide regular TMF status and compliance reports to the Study Lead and key stakeholders
• Clarify functional document ownership and submission expectations

Cardiovascular Account Specialist

Senior Manager, Regulatory Writing

Contract – Trial Master File Manager