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Amgen Inc
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Associate Regulatory Writing

Associate Regulatory Writing

Amgen Inc

1 - 3 years

3 - 5 Lacs

hyderabad

Posted:11 hours ago| Platform:

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Skills Required

business process biotechnology basic compliance pharma project management clinical research issue resolution management auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Career Category Regulatory Job Description

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
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

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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Associate Regulatory Writing