Senior Manager, Regulatory Writing

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is dedicated to upholding the highest standards of excellence to bring potential medicines to patients to improve outcomes and quality of life. We are looking for Regulatory Affairs professionals who bring a strategic mindset and a deep understanding of the regulatory environment. As a member of the team, you will play a crucial role in ensuring our processes meet regulatory requirements while maintaining high standards of compliance. The Senior Manager, Regulatory Writing is responsible for authoring regulatory documents, including but not limited to clinical study protocols, protocol amendments, clinical study reports (CSRs), clinical summaries, investigator’s brochures (IBs), pediatric documents, and regulatory authority briefing materials and responses. The individual will work independently with minimal oversight and in close collaboration with cross‑functional teams to lead the development of these documents. Responsibilities Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, and clinical summaries for complex submissions (IND, NDA, BLA, MAA). Provide support for health‑authority briefing documents and responses to questions/requests for information. Act as the lead writer and primary point of contact for assigned programs while support document timelines and content strategy. Oversee additional writing and QC work performed by vendors. Plan kickoff meetings, define overall timelines, and lead authoring and comment resolution for large, complex documents such as CSRs. Arrange and conduct comment‑resolution and review meetings with cross‑functional teams. Collaborate with Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology, and other cross‑functional stakeholder groups to set priorities, review content, and ensure scientific accuracy. Represent Regulatory Writing on project teams and advise on fit‑for‑purpose content and format requirements. Develop and drive timelines, and communicate the writing process to team members. Provide status updates of Regulatory Writing deliverables to management. Share and implement best practices to ensure efficiency and consistency across product teams. Contribute content to safety documents such as DSURs and RMPs. Serve as a subject‑matter expert on systems and process initiatives, including document‐management‐system implementations. Comply with established company policies, procedures, and industry and regulatory guidelines. Other duties as assigned. Qualifications BA/BS in a life‑science discipline with at least 8+ years of scientific or medical writing experience in a biotech or pharmaceutical company, OR MA/MS/PhD with at least 5+ years of regulatory/medical writing experience and a deep understanding of regulatory standards. Excellent oral and written communication skills. Ability to work independently and cross‑functionally with minimal supervision. Demonstrated ability to lead the development of large/complex regulatory and clinical documents, including CSRs, Module2 summaries, and regulatory‑authority‑meeting briefing documents. Ability to engage and disseminate information among appropriate stakeholders for effective document preparation. Strong attention to detail and the ability to write or summarize science‑and‑data‑driven content into clear, concise, and complete documents. Skilled in verifying data integrity, identifying errors and inconsistencies across various document types, and addressing them effectively. Ability to work effectively in a fast‑paced environment with multiple high‑priority projects. Ability to oversee consultants or contractors and serve as a liaison for project purposes. Excellent project‑management skills. Knowledge of regulatory guidelines such as ICH and Good Clinical Practice (GCP). Benefits Pay Range: $173,700 – $202,650 per year (U.S.) Remote work available. Cytokinetics is an Equal Opportunity Employer. #J-18808-Ljbffr