Sr Associate Regulatory Writing

Amgen Inc

2 - 7 years

2 - 5 Lacs

hyderabad

Posted:13 hours ago| Platform:

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Skills Required

project management regulatory documentation clinical research regulations fda usfda ich-gcp guidelines ent regulatory compliance gmp pharmacovigilance ra ich ctd quality assurance regulatory affairs drug regulatory affairs clinical trials dmf

Work Mode

Work from Office

Job Type

Full Time

Job Description

ABOUT AMGEN

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, Amgens 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:

Bachelors 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

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