Job Title: Global Clinical Publishing Associate
Company: Novartis Healthcare Private Limited
Division / Business Unit: Development / Research & Development
Location: Hyderabad, India (Office)
Date Posted: Dec 03, 2024
Job Type: Full-time, Regular
Shift Work: No
Role Summary:
The Global Clinical Publishing Associate ensures compliance with internal and external guidelines to compile, integrate, and publish clinical and regulatory documents. This role supports timely submission of documents to Health Authorities (HAs) and provides publishing consultancy to clinical teams and other line functions.
Key Responsibilities:
Compile, integrate, and publish clinical documents in collaboration with clinical teams using word processing, electronic publishing, and document management systems.
Perform technical quality control (electronic functionality, adherence to internal and external standards) of published documents.
Maintain knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
Act as the Program Publisher under the supervision of the immediate manager for various clinical development programs.
Ensure published documents meet internal and external quality standards, minimize technical QC findings, and require no rework once finalized.
Deliver documents in a timely manner in alignment with project and departmental KPIs.
Key Performance Indicators (KPIs):
Timely and accurate publication of clinical documents based on complexity and size.
Compliance with internal and external quality standards for submissions.
Minimal publishing-related errors and rework.
Meeting individual document timelines and overall project timelines.
Minimum Requirements / Qualifications:
Experience with regulatory submission formats, including CTD format criteria.
Familiarity with regulatory requirements and Health Authority guidance (FDA, ICH, EMA).
Effective interpersonal, written, and oral communication skills.
Project management and time management skills for multiple ongoing projects.
Working knowledge of regulatory affairs and clinical documentation processes.
Proficiency with computer programs/systems (MS Office, etc.) and ability to learn new systems quickly.
Analytical and problem-solving skills.
Ability to work independently and coordinate effectively with cross-functional teams.
Desired Skills / Competencies:
Clinical Study Reports (CSR) preparation
Data analysis
Documentation management
Operational excellence
Regulatory compliance
Lifesciences domain knowledge
Cross-cultural collaboration and operations management
Languages Required:
English
Additional Information / Benefits:
Novartis offers competitive benefits and rewards, focusing on personal and professional growth.
The company promotes an inclusive and accessible work environment and reasonable accommodations for individuals with disabilities.
Employees are encouraged to join the Novartis talent network to stay informed about suitable career opportunities.
Contact for Accommodation: diversityandincl.india@novartis.com (include job requisition number: REQ-10006976)
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