Associate Regulatory Writing
Associate Regulatory Writing
India - Hyderabad APLICAR AHORAABOUT 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, 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:
- Bachelor’s 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), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
- Familiarity with redaction/anonymization of clinical trial documents
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.