Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Publisher - I
Job Description
1) 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.
2) Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents.
3) Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
4) Act as the Program Publisher for various programs in clinical development to ensure publishing resources are allocated to program-specific studies and submissions.
5) Provide input and advice to project and trial teams on the “publishing-readiness” requirements for document components.
6) Provide input on process issues to Document Management as relevant.
1) 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.
2) Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents.
3) Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
4) Act as the Program Publisher for various programs in clinical development to ensure publishing resources are allocated to program-specific studies and submissions.
5) Provide input and advice to project and trial teams on the “publishing-readiness” requirements for document components.
6) Provide input on process issues to Document Management as relevant.
Candidate Profile
1. Masters Degree in Science or Pharmacy with Minimum 3 years to 5 years of relevant experience in publishing/Regulatory Operations
2. Ability to plan and priorities workload
3. Ability to work in a matrix environment
4. Ability to build effective relationships across teams
5. Active command in English with excellent written and spoken communication skills
6. Good knowledge of Regulatory tools.
7. Adequate knowledge of software and computer tools.
8. Creative thinking and effective interdisciplinary collaboration with other functions.
1. Masters Degree in Science or Pharmacy with Minimum 3 years to 5 years of relevant experience in publishing/Regulatory Operations
2. Ability to plan and priorities workload
3. Ability to work in a matrix environment
4. Ability to build effective relationships across teams
5. Active command in English with excellent written and spoken communication skills
6. Good knowledge of Regulatory tools.
7. Adequate knowledge of software and computer tools.
8. Creative thinking and effective interdisciplinary collaboration with other functions.
Additional Information
Experience : 3-5 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th May, 2018
Experience : 3-5 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th May, 2018
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