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Post: H and LS Medical Writer
Job Description:
Writing, Reconciling, editing and/or managing the production of high quality clinical documents that are components of regulatory marketing approval. Knowledge of clinical terminology is a must. They ensure that documents are written consistent with company and regulatory guidelines.
Responsibilities/Authorities:
- Writing first draft of Aggregate Report (e.g. RMP, PVP, PSURs, PADERs, ASRs, QSUSARs) oLiterature Search
- Newly analyzed, ongoing and completed study information from, but not limited to, clinical, non-clinical, and epidemiology studies. oCurrent Reference Safety Information (e.g., CCSI/CCDS/CPLP)
- Conduct analysis of singles cases extracted oEnsure consistency with quality, accuracy, and medical safety standards
- Review and follow-up reports with relevant stakeholders internally (Lead TA, local market PV, Global Regulatory Teams, Medical Surveillance Team, Pharmaco-epidemiology, etc.)
- Attaches/ reviews all letters and queries for appropriateness and completeness
- Oversees all the team resources in the work
- Oversee execution of Quality Control and discrepancy management for outputs
- Assist in training for new resources and as a part of continuous improvement
- Assist in the development of documentation such as work instructions or task checklists for readiness activities as required
- Ensure compliance with client and company policies
- Own assist and comply to all SLAs (Cycle time and quality)
Candidate Profile
Ph.D. in Life Sciences or Pharmacy/M.D. in Pharmacology or Physiology or Human Genetics or Public Health
Additional Information:
Experience: 4-6 years
Location: Chennai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Coder
Job Number: J1740
End Date: 20th January, 2016
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