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 Senior Medical Writer
Job Description:
Job Purpose (State in one sentence the overall objective of the role)
To write, edit, reconcile and manage high quality medical and scientific communications including narratives, CTRDs, CTDs and Phase 1 & 2 CSRs for publication/ presentation or for submission to regulatory authorities and/or clinical teams.
Major Activities
1. Prepares patient narratives, CTRDs, CTDs and Phase 1 & 2 CSRs, manuscripts (simple) working from various data sources including clinical study reports, patient profiles, protocols etc.
2. Performs quality control (QC) checking / proof reading of narratives, CTRDs, CTDs, literature review, abstracts, posters, and slide sets to meet customer expectations.
3. Manages up to two assigned team projects at any given time.
4. Ensures getting feedback from customers and supports implementation of customer management tactics.
5. Comply with and support group’s project management tool, standards, policies and initiatives.
6. Follow Novartis specifications for documentation, specifically Novstyle, templates etc.
7. Follow and track clinical trial milestones for assigned projects.
8. Maintain records for all assigned projects including archiving.
9. Maintain 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:
- Impact on the organization: Timely preparation of medical and scientific documents to meet regulatory requirements, for publication of clinical trial results, to increase customer awareness of company products, and to support marketing activities.
- Ideal Background (State the preferred education and experience level) Education (minimum/desirable): Minimum science degree or equivalent,
B.Sc./equivalent with 6 years Clinical Research (CR) experi-ence, M.Sc./M.Pharm +4 years of clinical research (CR) ex-perience
Desired – Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent) PhD + 2 year of CR experience, MBBS/equivalent + 2 year of CR experience, MD +1 year of CR exp
Languages: Excellent written and oral English
Additional Information:
Experience: 1-6 years
Location: Hyderabad / Secunderabad
Education: M.Pharm, B.Sc, M.Sc, Ph.D, MBBS, MD
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Medical Writer
Job ID: 65053BR
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