Associate - Regulatory Writing

2 days ago

Hyderabad, Telangana, India Amgen Inc Full time

Roles & Responsibilities:

  • Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
  • Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
  • Collaborate with team members to resolve problems and escalate issues
  • Record and maintain written redaction strategy for the study and product
  • Manage timelines and coordinate work across team
  • Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen 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
  • Project management skills, including ability to prioritize work in order to meet required deadlines
  • Problem solving ability

Basic Qualifications:

  • Bachelors degree
  • Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment
  • Familiarity with clinical research and clinical regulatory documents
  • Knowledge of clinical trial disclosure regulations, guidelines, and best practices

Preferred Qualifications:

  • One year experience preparing regulatory documents for public disclosure
  • Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), , EudraCT, EU CTIS, and other registries
  • Familiarity with redaction/anonymization of clinical trial documents

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