Home
Jobs

Global Clinical Publishing Associate

3 - 5 years

12 - 16 Lacs

Posted:1 day ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.
Key Responsibilities
  • In collaboration with the clinical teams, compile, integrate and publish clinical documents with 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.
  • Under direct supervision of the immediate manager, acts as the Program Publisher for various programs in clinical development.
  • Publish clinical documents (taking into account 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, including minimizing publishing-related technical QC findings and no rework once finalized.
  • Timeliness of deliverables meet both individual document and overall project timelines.
Minimum Requirements
  • 3-5 years submission publishing experience in Pharma or related industry.
  • Experience with regulatory submission format, 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.
  • Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
  • Working knowledge of regulatory affairs, works independently and with minimal supervision.
  • Proficiency with computer programs/systems (MS office, etc. ) with demonstrated ability to learn new systems quickly.
  • Analytical skills and problem solving skills, ability to coordinate and work effectively with cross-functional teams.

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
NOVARTIS
NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

RecommendedJobs for You

Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru

Gurugram, Haryana, India