Novartis Hiring: Global Clinical Publishing Associate
About Company:
Ensure compliance with internal and external guidelines, compile and add electronic navigation to clinical and regulatory documents. Support timely submission of documents to Health Authorities (HAs) and provide publishing consultancy to clinical teams and other line functions.
Position Name: Global Clinical Publishing Associate
Organization: Novartis
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience: 1 to 2 Years
Salary: Not Disclosed
Location: India
Major Accountabilities:
- Compile, integrate, and publish clinical documents using word processing, electronic publishing, and document management systems.
- Perform technical quality control of published documents.
- Maintain knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
- Act as the Program Publisher for various programs in clinical development.
Key Performance Indicators:
| Task | Expectation |
|---|---|
| Publish Clinical Documents | In accordance with department standards and organization KPIs |
| Quality of Published Documents | Meet current internal and external quality standards for electronic and/or paper HA submissions |
| 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 and time management skills to handle multiple ongoing projects simultaneously.
- Familiarity with regulatory requirements and HA guidance, including FDA regulations, ICH, and EMA guidelines/directives.
- Ability to work independently and with minimal supervision.
- Proficiency with computer programs/systems (MS Office, etc.) with the ability to learn new systems quickly.
- Analytical 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.
- Life Sciences.
- Operational Excellence.
- Regulatory Compliance.
Languages: English
