Job ID: REQ-10006976
Date Posted: May 26, 2024
Location: India, Hyderabad (Office)
Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No
Summary:
Ensure compliance with internal and external guidelines to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions.
About the Role:
Major Accountabilities:
Collaborate with clinical teams to compile, integrate, and publish clinical documents using word processing, electronic publishing, and document management systems in the Novartis Development environment.
Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents.
Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
Act as the Program Publisher for various programs in clinical development under direct supervision of the immediate manager.
Key Performance Indicators:
Publish clinical documents (considering complexity and size) in accordance with department standards and organization KPIs.
Ensure published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, minimizing publishing-related technical QC findings, and avoiding rework once finalized.
Ensure the timeliness of deliverables meets both individual document and overall project timelines.
Minimum Requirements:
Experience with regulatory submission formats, including familiarity with submission publishing activities and CTD format criteria.
Effective interpersonal skills, strong written and oral communication, and presentation skills.
Project management and time management skills to manage multiple ongoing projects simultaneously.
Familiarity with regulatory requirements and HA guidance, including FDA regulations, ICH, and EMA guidelines/directives.
Working knowledge of regulatory affairs.
Ability to work independently with minimal supervision.
Proficiency with computer programs/systems (MS Office, etc.) and demonstrated ability to learn new systems quickly.
Analytical skills and problem-solving skills.
Ability to coordinate and work effectively with cross-functional teams.
Work Experience:
Cross-cultural experience.
Functional breadth.
Collaborating across boundaries.
Operations management and execution.
Project management.
Skills:
Clinical Study Reports.
Data Analysis.
Documentation Management.
Lifesciences.
Operational Excellence.
Regulatory Compliance.
Languages:
English.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more about our people and culture: Novartis People and Culture
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Novartis Talent Network
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