H and LS Medical Writer
1 - 3 Years
Chennai
Job Description
OVERALL PURPOSE OF JOB
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.
PROCESSES :
.
Responsibilities/ Authorities :
oWriting first draft of Aggregate Report (e.g. RMP, PVP, PSURs, PADERs, ASRs, QSUSARs)
oLiterature Search
oNewly 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)
oConduct analysis of singles cases extracted
oEnsure consistency with quality, accuracy, and medical safety standards
oReview 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)
Requirements:
- No special physical demands.
- Major part of work done in office environment.
- High degree of accuracy and attention to detail.
- Good decision making ability.
- Demonstrated strong writing skills and has written publications.
- Ability to analyze, understand and interpret complex scientific data from a broad range of scientific disciplines
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.
PROCESSES :
.
Responsibilities/ Authorities :
oWriting first draft of Aggregate Report (e.g. RMP, PVP, PSURs, PADERs, ASRs, QSUSARs)
oLiterature Search
oNewly 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)
oConduct analysis of singles cases extracted
oEnsure consistency with quality, accuracy, and medical safety standards
oReview 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)
Requirements:
- No special physical demands.
- Major part of work done in office environment.
- High degree of accuracy and attention to detail.
- Good decision making ability.
- Demonstrated strong writing skills and has written publications.
- Ability to analyze, understand and interpret complex scientific data from a broad range of scientific disciplines
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