Sr Associate Regulatory Writing

As an integral part of the Amgen team, you will be responsible for preparing clinical regulatory documents for public disclosure. This includes tasks such as anonymization of personal data, redaction of commercially confidential information, and preparation of documents for public registries like ClinicalTrials.gov. You will collaborate closely with cross-functional stakeholders to define redaction strategies and ensure submission readiness. Your role will also involve maintaining consistent quality across documents, resolving problems, and escalating issues when necessary. Additionally, you will record and maintain written redaction strategies for studies and products, support trend analysis, process improvement, and execute clinical trial disclosure business processes in compliance with regulations, Amgen's policies, and SOPs. Key Responsibilities: - Prepare clinical regulatory documents for public disclosure - Work with cross-functional stakeholders to define redaction strategy and ensure submission readiness - Record and maintain written redaction strategy for the study and product - Support trend analysis and process improvement - Execute clinical trial disclosure business process in compliance with regulations and company policies - Serve as a tactical point of contact for assigned areas of responsibility - Assist/support trial disclosure audits and inspections - Serve as Process Administrator for CTRS and support active CTRS users - Generate/manage reports, trackers, portals, and metric activities In order to excel in this role, you should possess the following qualifications: - Experience in understanding and interpreting data/information for practical application - Self-motivated with strong multi-tasking, attention to detail, and follow-through skills - Ability to follow controlled processes - Excellent spoken and written English - Strong communication and negotiation skills to influence stakeholders - Project management skills with the ability to prioritize work to meet deadlines - Problem-solving ability Basic Qualifications: - Bachelor's degree - Minimum of 2 years" experience in preparing regulatory documents for public disclosure - Understanding of clinical research and clinical regulatory documents - Working knowledge of clinical trial disclosure regulations, guidelines, and best practices Amgen is committed to providing equal opportunities for all individuals. If you require accommodation to participate in the job application or interview process, perform essential job functions, or receive other benefits and privileges of employment, please reach out to us to request an accommodation.,