Senior Manager, Regulatory Writing

🕒 March 6

🇺🇸 United States – Remote

💵 $173.7k - $202.7k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

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Cytokinetics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 $450M Post-IPO Debt on 2022-06

Biotechnology • Pharmaceuticals • Healthcare Insurance

Cytokinetics is a late-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of potential medicines aimed at improving muscle function. The company is particularly active in developing treatments for cardiovascular and neuromuscular diseases, such as heart failure, hypertrophic cardiomyopathy, and other conditions of impaired muscle function. Cytokinetics has a robust pipeline of small molecule muscle activators and inhibitors and is committed to improving patients' lives through its scientific research and development efforts. The company's mission revolves around empowering muscle and thereby empowering lives, with patients being the central focus of its activities. Based in South San Francisco, Cytokinetics has been pioneering the field of muscle biology for over 25 years.

📋 Description

• 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. • If a lead writer for assigned programs, serves 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. • May oversee additional writing and QC work performed by the vendors. • For large, complex documents (e.g., CSRs), 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 (e.g. comments and questions arising from the writing/review process). • 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).

🎯 Requirements

• BA/BS in one of the life sciences with a minimum of 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience with a deep understanding of regulatory standards and data-driven documentation. • 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 development of large/complex regulatory and clinical documents including but not limited to CSRs, module 2 summaries, and regulatory authority meeting briefing documents. • Ability to engage and disseminate information among appropriate stakeholders for effective document preparation. • Strong attention to detail with the ability to effectively write/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/contractors and serve as a liaison for project purposes. • Excellent Project management skills. • Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP).