H and LS Medical Writer
2 - 6 YearsChennai
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
Company Profile
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functionsunderpinned by the worlds largest delivery networkAccenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 373,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com
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