Senior Manager, Regulatory Writing
Cytokinetics
full-time
Posted on:
Location Type: Remote
Location: Remote • Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $173,700 - $202,650 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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.
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
- 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).
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical writingregulatory writingmedical writingdata-driven documentationdocument managementproject managementscientific accuracycontent strategycomment resolutiondocument preparation
Soft skills
communication skillsattention to detailindependent workcross-functional collaborationleadershipinformation disseminationproblem-solvingtime managementadaptabilitystakeholder engagement