Clinical Trials Disclosure Associate

2 days ago

Hyderabad Telangana, India Amgen Full time

**Clinical Transparency & Disclosure Associate**

**Role Name**:Clinical Transparency & Disclosure Sr. Associate

**Department Name**:Global Regulatory Affairs & Strategy (GRAAS)

**Role GCF**:3

**Hiring Manager Name**:Jennifer Vande Weghe

**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, 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

**Required Skills**:

- 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

**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.

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