Oncology Medical Writer requires in Novartis

By: Mitul Shah | Views: 4066 | Date: 21-May-2010

Oncology Medical Writer requires in Novartis

A global healthcare leader, 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: Oncology Medical Writer

Job Description:
1. Prepares patient narratives, CTRDs, CTDs and phase I clinical study reports working from various data sources including clinical study reports, patient profiles etc..
2. Performs quality control (QC) checking / proof reading of narratives and CTRD documents to meet customer expectation.
3. Manages assigned individual projects.
4. Obtains feedback from customers.
5. Complies with and support group’s project management tool, standards, policies and initiatives.
6. Follows Novartis specifications for documentation, specifically Novstyle, templates etc.
7. Follows and track clinical trial milestones for assigned projects.
8. Maintains records for all assigned projects including archiving.
9. Maintains audit, SOP and training compliance.
10. Performs additional tasks as assigned.

Key Performance Indicators (Indicate how performance for this role will be measured)
1. Preparation of the above referenced documents meeting set quality standards and on time for submission to Health Authorities/ Clinical teams / Journals as appropriate. (i.e. complying with standards e.g. CONSORT regarding publication of trial results, complying with journal formatting requirements etc).
2. Publications are acceptable to internal and external authors (no issues with authorship).
3. Publications are acceptable to marketing and other internal customers.
4. Completion of an adequate number of medical and scientific documents (taking into account complexity) per year.

Candidate profile:
Minimum: Life-science degree or equivalent
B.Sc./equivalent with 4 years Clinical Research (CR) experience, M.Sc./M.Pharm + 2 years of CR experience,
Desired – Doctoral degree, Qualification in Medical Sciences (MBBS/MD/equivalent)
PhD + 1 year of CR experience, MBBS/equivalent + 1 year of CR experience
Good written and oral English skills

Additional Information: 
Experience: 2-4 years
Location: Hyderabad
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Development & Medical
Job ID: 68123BR

clik here to apply

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