Sr Associate Regulatory Writing

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Roles & Responsibilities:

• Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov
• Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
• Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
• Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues
• Record and maintain written redaction strategy for the study and product
• Support trend analysis and process improvement
• Execute clinical trial disclosure business process and ensure
• delivery in compliance with regulations, Amgen’s policy and SOPs/ and guidance documents
• Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
• Assist/support trial disclosure audits and inspections
• Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
• Generate /manage reports, trackers, portals and metric activities
  
  

Required Skills:

• Experience understanding and interpreting data/information and its practical application
• Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
• Ability to follow controlled processes
• Excellent spoken and written English
• Ability to communicate and negotiate to influence stakeholders
• Project management skills, including ability to prioritize work in order to meet required 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
  
  

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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