Senior Manager, Regulatory Writing

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. This individual will work independently with minimal oversight and in close collaboration with cross-functional teams to lead the development of these documents. All work must ensure scientific accuracy, alignment with study and submission objectives, compliance with standard operating procedures (SOPs), ICH/GCP and regulatory guidelines, and company goals. The Senior Manager will interpret and summarize complex regulatory data from a variety of sources in a concise, fit-for-purpose manner. This role requires strong attention to detail, critical thinking, and adherence to best writing practices. The Senior Manager will also lead and facilitate cross-functional meetings such as document kickoff meetings, data interpretation meetings, and comment resolution meetings. In addition, the role involves managing multiple complex writing projects, requiring excellent time management, problem-solving, and stakeholder engagement skills. The individual in this role will have demonstrated experience as a lead writer for a range of regulatory documents, including submissions, briefing materials, and responses to health authority questions. The role may also support other departmental Regulatory Writing activities as needed.

Responsibilities

• 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). In addition, 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).
• 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.

Qualifications

• 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).

#LI-REMOTE Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $173,700 - $202,650 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our Apply tot his job Apply To this Job